Careers with Cirtec – Medical Device Design, Manufacturing, and Finished Device Assembly

We actively seek creative candidates in the fields of sales, program management, mechanical engineering, quality engineering, electronics and software engineering, process engineering, and manufacturing engineering, including technicians, assemblers and supervisors. Our employees have the satisfaction of knowing that the work they do is helping patients live better, longer lives, and they take pride in the work they perform for one of the industry’s top medical device companies. Here at Cirtec, every employee is highly valued and crucial to our success. We place a high value on performance excellence, career development, safety, rewards and communication. Cirtec has rewarding opportunities where you can make a difference. To view all current positions and apply online, visit the Cirtec Career Center:

If you value teamwork, client focus, accountability and innovative thinking, Cirtec is the place for you! We want to be your career choice in the Medical Device Industry. Cirtec is an equal opportunity employer and does not discriminate based on race, gender, ethnicity or sexual orientation.

Opportunities in Brooklyn Park, MN

Machine Maintenance Technician

Summary:

This position is responsible for preventative maintenance on all machines in the production areas ensuring optimum performance.

This position is first shift.

Responsibilities:

  • Maintain preventative operation of all production equipment
  • Perform preventative maintenance as instructed by the Computer Machine Maintenance System (CMMS)
  • Complete work orders in the specified time, directed by the CMMS
  • Perform projects and other duties in a similar nature and complexity, as assigned by Manager
  • Keep work area clean and presentable while performing assigned tasks
  • Must be able to use basic hand and power tools
  • Work in a safe manner
  • Safely use chemicals while performing assigned tasks
  • Lock/Out Tag Out of equipment when necessary, or instructed by Manager
  • Able to work independently when performing assigned tasks
  • Accountable for work performed
  • Performing Coolant tank Cleaning

Qualifications:

  • 2+ years’ practical hands-on experience
  • Good Mechanical aptitude
  • Some Electronic/Electrical experience
  • Some Prior machine tool maintenance would be helpful
  • Must be willing to learn All Aspects of machine tools, Fabrication and Clean room equipment

PHYSICAL DEMANDS
While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 50 pounds.

The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

WORKING ENVIRONMENT
Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Vice President Quality Assurance & Regulatory Affairs

Summary:

As the VP of RA/QA, you will be responsible for the management, development, implementation and coordination of the regulatory affairs and quality assurance functions with a focus on understanding, implementing and ensuring compliance with global quality/regulatory requirements for Cirtec Medical. The successful candidate will build a flexible and knowledgeable team able to develop and execute quality and regulatory strategies tailored to the needs of each customer in a broad risk spectrum of product categories.

Responsibilities:

  • Manages and direct all areas of Regulatory Affairs, Quality Systems and related customer communication.
  • Develops, implements, and maintains required Regulatory compliance with all requisite regulatory agencies, including, but not limited to, U.S. FDA, EU/ISO, Canadian, Asia-Pacific and Latin America regulations.
  • Maintains current working knowledge of FDA and global regulatory requirements, and keeps Management apprised of new developments and potential impacts to our customers and the organization.
  • Establishes and executes processes to provide customers with Regulatory Affairs support, including preparation and planning of submissions.
  • Ability to interact with Global Regulating Agencies (FDA, Notified Bodies, etc.) to secure product approvals and define Regulatory strategies. Respond to requests from regulatory agencies. Leads in the creation of reports and documentation needed for regulators.
  • Designs and implements programs, policies, and practices to ensure Quality Assurance, GMP compliance, and lead a quality culture within the organization.
  • Responsible for and leads all aspects of the company’s ISO and FDA compliance.
  • Manages strategy and approach for all inspection/audits in compliance with local and global regulatory agencies and with customers.
  • Provides Quality Assurance oversight of vendors; prepare and maintain quality agreements. Promotes and maintains Certified Supplier programs, including required audits.
  • Responsible for CAPA, Non-conformance Reporting, deviations, and product complaint investigations.
  • Facilitates improvement in quality tools and techniques including SPC and provides quality and statistical expertise to team.
  • Manages changes in systems or procedures when necessary. Develop appropriate change and communication approach as needed.
  • Provides sponsorship and acts as change facilitator for APC, FMECA, DOE and process validation.
  • Develops and manages departmental strategic plans, tactics, and budgets.
  • Promotes organization to customers around the world and fosters customer/industry relations.
  • Other responsibilities and duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum 15 years of experience in a medical device environment in increasing leadership roles, preferably in a Regulatory Affairs or Quality, with supervisory and decision-making responsibilities.
  • Bachelor of Science, preferably in an engineering discipline (Master’s Degree preferred.
  • Quality/Regulatory Certifications (preferred).
  • Experience in managing regulatory submissions for CL II and CL III active implantable products.
  • Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), especially pertaining to product development, manufacturing, supplier management, quality control and customer complaints.
  • Experience in effectively managing audits by customers and regulatory agencies.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
  • Strong verbal and written communication skills; ability to present complex data to internal and external contacts.
  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines, while increasing employee engagement and retention.

PHYSICAL DEMANDS:
While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT:
Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Coordinator

Summary:

A material coordinator maintains production and distribution of product by pulling orders from inventory; delivering production materials and supplies; staging finished product.

Responsibilities:

  • Maintains inventory by identifying, labeling, and placing materials and supplies in stock, recording location of inventory.
  • Locates materials and supplies by pulling and verifying materials and supplies listed on production orders
  • Maintains in-process inventory at work centers by delivering and opening materials and supplies
  • Documents materials and supplies disposition by recording units delivered and location of units
  • Receives credit-return material and supplies from production by verifying materials and supplies code and lot number and quantity, placing materials in stock
  • Prepares finished stock for shipment by identifying, pulling, packing, crating, loading, and securing product
  • Documents product shipment by recording units shipped
  • Maintains material-handling equipment by completing pre-use inspections, making operator repair notes
  • Contributes to team effort by accomplishing related results as needed
  • Review jobs requiring materials via the ERP system
  • Issue materials to assigned jobs physically and in ERP system
  • Return materials from completed jobs physically and in ERP system if applicable
  • Perform monthly cycle count in assigned area(s)
  • Communicate any material shortages to appropriate departments as needed
  • Prepare outgoing shipments to subcontract suppliers
  • Copy all documents necessary for and file into the DHR file
  • Maintain and monitor manual or computerized inventory control system for raw materials and finished stock
  • Investigate all discrepancies
  • Perform cycle counts and assist with annual physical inventory as required
  • Support or provide back-up to Shipping, Production and Inventory Control functions as required
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or GED required, college experience a plus
  • 2+ years’ experience in materials management desired
  • Be able to read, write and speak fluent English
  • Must have good communication skills and work well with people
  • Attention to detail.
  • Computer literate (MS Office Suite, Syteline, ERP/MRP)
  • Ability to interpret written and verbal work instructions
  • Able to think creatively, get out of the box and solve problems
  • Must have good organizational and time management skills
  • Understanding of scheduling and the importance of details, accuracy, and meeting deadlines
  • Continually looks for Process Improvement opportunities
  • Accurate data entry skills and understanding of Inventory Control
  • Knows how to work safely and looks for opportunities to improve safety

PHYSICAL DEMANDS
While performing the duties of this job, the employee is frequently required to talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee will be on their feet for entire shift. The employee must be able to lift 50 pounds. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT
Work is performed in a warehouse and cleanroom environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Calibration Technician

Summary:

This position will be responsible for ensuring Cirtec Medical inspection and testing equipment meets all defined and specified requirements related to their mechanical, electrical, and/or electronic performance, maintenance and calibration to ensure measurement/testing accuracy as applied to the determination of conformity for Quality Assurance and Control of Cirtec Medical products.

Responsibilities:

  • The position will be responsible for ensuring operational adherence and compliance to Cirtec Medical’s Quality Management System (QMS) requirements.   Specific elements of the QMS, as part of daily essential duties and responsibilities, include:
    • Inspection/Test Equipment Calibration & Maintenance,
    • Inspection/Test Equipment Selection and Qualification (Metrology and Gage R&R),
    • Inspection/Test Equipment Identification and Control.
    • Maintenance of the Calibration System to ensure that all inspection, measurement and test equipment, including mechanical, automated, of electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing accurate and valid results.
  • Additional duties and responsibilities include, but are not limited to:
    • Present equipment calibration and maintenance data to internal and external partners/customers.
    • Utilize knowledge of Statistical methods and tools to monitor and report on calibration system status and compliance.
    • Perform periodic audits of the calibration and maintenance systems to ensure compliance, control and accurate reporting of inspection/test equipment.
    • Support site internal and customer-requested auditing activities (Cirtec, Customer and Customer Regulatory Agencies).
    • Support and reinforce Quality Best Practices and GDP/GMP behaviors and continuous improvement efforts within Cirtec Medical.
    • Ensure all personnel are knowledgeable of, and adhere to, the Cirtec Medical Quality Management System and its requirements.
    • Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidelines and rules.
    • Must maintain an organized and operationally effective work environment.
    • Must adhere to professional workplace attire, time, attendance and leave of absence policies.
    • Other duties and responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

Required Education & Experience: 

  • High School Diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
  • 1-5 years of Manufacturing Quality experience.

Preferred Qualifications & Experience:

  • Post-Secondary Education/Training/Certification coursework (Manufacturing or Engineering discipline preferred).
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Other regulated manufacturing industry experience (e.g. Aerospace, Automotive, Defense, Pharmaceutical, etc.)
  • Knowledge of, and experience with, GMP/ISO Standards.

Technical Requirements, Skills and Training:

  • Strong verbal and written English language communication skills.
  • Must demonstrate ability to perform visual inspections (i.e. detect defects) using a microscope and/or magnification visual inspection system.
  • Must demonstrate ability to read manufacturing prints and identify associated specification/characteristics related to inspection and testing to be performed.
  • Must have a fundamental understanding of Quality Management Systems and how Calibration Systems fit in the overall scheme of Manufacturing Quality Control and compliance.
  • Must have a fundamental understanding of Quality philosophies, principles, systems, tools, standards and controls, internal customer service, and professional ethics.
  • Must be able to successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements as provided.
  • Must demonstrate ability and/or experience in computer use and general office software – Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT
Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Laser Technician

Summary:

This position is responsible for the safe and functional operation of laser cutting and welding equipment.  Will be responsible for developing manual or CAD programs required to cut or weld components.  Will assist in the development of tooling and fixtures required.

There are two positions open one on second shift and one on weekend shift.

Responsibilities:

  • Job set up and first piece check.
  • Provide process training to production operators
  • Perform characterizations, IQ’s, OQ’s, PQ’s, and validations
  • Provide Laser samples when appropriate to support sales effort
  • Provide assistance to Engineering to develop laser quotations and manufacturing procedures
  • Develop CNC programming using a camming software to efficiently meet print requirements
  • Assist Engineering in designing tooling for production
  • Interface with Quality to develop inspection procedures to verify acceptability of components
  • Maintain and promote laser and team safety
  • Evaluate and recommend alternative manufacturing methods
  • Maintain and encourage other to maintain a clean and orderly work area
  • Research and recommend capital equipment for the yearly budget
  • Ensure laser maintenance program is 100% up to date
  • Provides leadership to the team and interrelates well with all areas of the company
  • Effectively resolves all problems that arise or seek assistance in a timely manner
  • Assists the Team Manager in developing highly skilled individuals to be high quality efficient operators
  • Performs duties in a manner to promote good department morale with the team
  • Trains team members and new employee on machines and department procedures
  • Maintains schedules of machines to best meet customer requirements based on meeting daily production schedule as supplied by M2M and Production Control
  • Demonstrates responsibility for department efficiency, quality, pre-production planning, process control, corrective actions, cleanliness and safety
  • Ensures that job BOM’s are accurate and tooling is ordered on timely manner
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Recent pulsed laser cutting experience
  • Experience with high tolerance cutting, welding and drilling of metals
  • Set up of laser parameters
  • Experience or a desire to learn CAD/CAM software

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Laser Team Lead

Summary:

Lead team in a manner to maximize production, manage team production, Quality, and day-to-day functions. To be self-motivated. To ensure the product is done on time maintaining the highest quality possible and produced to meet production standards. To follow the department budget and is responsible for team to strive to meet company and department goals.

Responsibilities:

  • Provides leadership to the team and interrelates well with all areas of the company.
  • Effectively resolves all problems that arise or seek assistance in a timely manner.
  • Understands company policies and procedures and ensures the team members follows them.
  • Assists the Supervisor in developing highly skilled individuals to be high quality efficient operators.
  • Maintains schedules of machines to best meet customer requirements based on meeting daily production schedule as supplied by M2M and Production Control.
  • Performs duties in a manner to promote good department morale with the team.
  • Demonstrates responsibility for department efficiency, quality, pre-production planning, process control, corrective actions, cleanliness and safety.
  • Participates in maintaining budget goals.
  • Continually trains co-workers to encourage individual growth within company.
  • Programs jobs, sets up jobs and orders tooling as required.
  • Provides tool checks back to Engineering (within 24 hours of being requested if required).
  • Develops performance reviews and makes recommendations.
  • Works with Supervisor on employee disciplinary action in a professional manner as per company guidelines.
  • Assists in all department functions.
  • Seeks out new and better means of productivity.
  • Responsible for all quality and productivity within the department.
  • Trains team members and new employee on machines and department procedures.
  • Responsible for meeting or exceeding team budgets and goals.
  • Ensures that job BOM’s are accurate and tooling is ordered on timely manner.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum of 3 years’ experience in laser/team supervision.
  • Exceptional written and verbal communication skills.
  • Must work well with people and in a team environment.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Receiving Inspector

Summary:

In the fast-paced medical contract manufacturing space, this position is primarily responsible for ensuring incoming products and materials meet all defined specifications.  Also, our Receiving Inspectors assist with day to day inspection of Cirtec Medical products for determination of conformity to the requirements.

Responsibilities:

  • Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel.
  • Indicate inspection status of parts with assigned labels and stamps.
  • Maintain product identification and traceability.
  • Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action.
  • Protect product during handling and storage in the performance of work.
  • Monitor factory environmental conditions, record data and alert adverse conditions.
  • Assist with distribution and control of process documentation and quality records.
  • Assist with control of measuring and test equipment calibration.
  • Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
  • Assist with statistical methods of verifying and controlling process capability.
  • Provide input when required to quality planning for specific projects and products.
  • Provide leadership to production personnel on quality issues.
  • Comply with and reinforce the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations and other customer standards.
  • Follow Occupational Safety and Health regulations, including laser safety practices.
  • Other agreed duties within the Quality Department consistent with training, qualification and experience.
  • Provide Quality Support for the disposition of discrepant material.
  • Provide leadership to production personnel in relation to quality.
  • Provide Quality Control support to Manufacturing & Engineering.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Requires a high school diploma, GED, or equivalent
  • Requires directly transferrable work experience (experience in the engineering / manufacturing environment of medical device component assembly preferred)
  • 1-3 years of professional workplace experience
  • Prefer experience and familiarity with operations such as cleanroom manufacturing, swiss machining, milling, stamping, laser cutting, laser welding, coiling, crimping, swaging, adhesive bonding/backfill, liquid silicone & thermoplastic injection molding, annealing, and general mechanical assembly
  • Excellent working knowledge of technical drawings, blueprints, specifications, illustrations and geometric tolerances
  • Strong problem solving and process validation experience is a plus
  • Strong computer skills including MS Office, Project, Document Control systems, Adobe Acrobat
  • Must be able to read, write and speak fluent English
  • Possess good reading, writing, communication, and organizational skills
  • Maintain performance with changing priorities under minimal supervision
  • Possess strong team collaboration skills
  • Strong desire to learn and apply new technology
  • The employee may be required to work overtime and/or flexible hours, including weekends, nights and holidays based on special projects and/or critical situational business priorities.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.   The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 50 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT:

Work is performed in an office, cleanroom and/or manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Control Inspector – Third Shift

Summary:

This position is primarily responsible for performing receiving, first piece, in-process and final inspection or test on a wide variety of parts and document results. Indicate inspection status, maintain product traceability and non-conforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records and equipment calibration.

This position will be on third shift Sun-Thurs 11pm-7:30am

Responsibilities:

  • Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel.
  • Indicate inspection status of parts with assigned labels and stamps.
  • Maintain product identification and traceability.
  • Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action.
  • Protect product during handling and storage in the performance of work.
  • Monitor factory environmental conditions, record data and alert adverse conditions.
  • Assist with distribution and control of process documentation and quality records.
  • Assist with control of measuring and test equipment calibration.
  • Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
  • Assist with statistical methods of verifying and controlling process capability.
  • Provide input when required to quality planning for specific projects and products.
  • Provide leadership to production personnel on quality issues.
  • Comply with and reinforce the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations and other customer standards.
  • Follow Occupational Safety and Health regulations, including laser safety practices.
  • Other agreed duties within the Quality Department consistent with training, qualification and experience.
  • Provide Quality Support for the disposition of discrepant material.
  • Provide leadership to production personnel in relation to quality.
  • Provide Quality Control support to Manufacturing & Engineering.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English
  • High school diploma
  • 3-5 years’ minimum experience in manufacturing, preferably medical devices, with increasing responsibility or a minimum of 5 years’ experience in a manufacturing environment.
  • Certificate/s of training related to this field of work (medical or quality assurance
  • 3 years’ experience as a Quality Control Inspector
  • Proven experience in inspection and documenting results
  • Able to demonstrate competence in interpreting technical drawings & specifications
  • Proficient in the use of microscopes, measuring and test equipment
  • Able to check dimensions, squareness, hole locations, surface relationships, finish material defects and mechanical strength of product following appropriate training
  • Have experience in the use of PC’s and Microsoft Office software applications

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

WORKING ENVIRONMENT:

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Control Inspector

Summary:

This position is primarily responsible for performing receiving, first piece, in-process and final inspection or test on a wide variety of parts and document results. Indicate inspection status, maintain product traceability and non-conforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records and equipment calibration.

This position will be on first shift.

Responsibilities:

  • Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel.
  • Indicate inspection status of parts with assigned labels and stamps.
  • Maintain product identification and traceability.
  • Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action.
  • Protect product during handling and storage in the performance of work.
  • Monitor factory environmental conditions, record data and alert adverse conditions.
  • Assist with distribution and control of process documentation and quality records.
  • Assist with control of measuring and test equipment calibration.
  • Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
  • Assist with statistical methods of verifying and controlling process capability.
  • Provide input when required to quality planning for specific projects and products.
  • Provide leadership to production personnel on quality issues.
  • Comply with and reinforce the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations and other customer standards.
  • Follow Occupational Safety and Health regulations, including laser safety practices.
  • Other agreed duties within the Quality Department consistent with training, qualification and experience.
  • Provide Quality Support for the disposition of discrepant material.
  • Provide leadership to production personnel in relation to quality.
  • Provide Quality Control support to Manufacturing & Engineering.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English
  • High school diploma
  • 3-5 years’ minimum experience in manufacturing, preferably medical devices, with increasing responsibility or a minimum of 5 years’ experience in a manufacturing environment.
  • Certificate/s of training related to this field of work (medical or quality assurance
  • 3 years’ experience as a Quality Control Inspector
  • Proven experience in inspection and documenting results
  • Able to demonstrate competence in interpreting technical drawings & specifications
  • Proficient in the use of microscopes, measuring and test equipment
  • Able to check dimensions, squareness, hole locations, surface relationships, finish material defects and mechanical strength of product following appropriate training
  • Have experience in the use of PC’s and Microsoft Office software applications

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

WORKING ENVIRONMENT:

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Project Manager Transfers

Summary:

The Project Manager will play an integral part in leading Sustaining Transfer projects. Scope of projects includes all product support activities from validations, re-validations, layouts, and working with the customer. Project size ranges from small one-off tasks to large product transfers. Work directly with supporting cross-functions across operations and other manufacturing sites. Cross-functional teams include, but not limited to, Research & Development, Quality, Operations, Supplier Engineering/Quality, and Supply Chain.

Responsibilities:

  • Lead cross-functional teams and manages multiple projects from small to large scope, including schedule, scope, costs and resources.
  • Project Management and have direct contract with customers
  • Update the core team on timeline, cost, and delivery
  • Serve as core team member for strategic programs.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Develops and implements overall project plan, including cost, schedule, risk and performance and monitors progress against business key objectives and goals.
  • Identify prioritization and resources needs for assigned projects and activities with supporting cross-functions.
  • Identify, communicate and manage technical challenges and business risks.
  • Drive and influence results by acting with speed, agility and adaptability, assigning clear authority and accountability while integrating and aligning efforts across manufacturing sites.
  • Provides structured thinking to project team on overall approach and delegates as appropriate.
  • Leads the team in appropriate decision making through strong judgment and the ability to analyze options and implications.
  • Investigate and develop approach/solution to address technical problems with project teams.
  • Direct control over activities and budget of one or more functional areas, product groups, projects/programs and/or operations
  • Foster a diverse workplace that enables all team members to contribute to their full potential in pursuit of organizational objectives.
  • Provide timely communication on project progress updates to all relevant cross-functions and levels within the organization, including presentations to senior leadership.
  • Experience with and managing with ISO 9001 and ISO 13485 procedures preferred.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manager Assembly Engineering

Summary:

This position is primarily responsible to provide functional supervision to the manufacturing engineering department. The ME Manager will assist production technicians and project engineers in defining and developing processes prior to introduction into standard production and lead process improvement efforts and day-to-day support of production products. Managing new assembly products and contract review as these projects transition into operations.

Responsibilities:

  • Provide support & supervision to direct reports for the timely completion of projects, initiatives and key activities.
  • Mentor associates and foster a learning and growth environment. Perform evaluations at regular intervals.
  • Provides in-put for the budget process.
  • Organize a project plans with required actions.
  • Track and communicate project status, plans, issues, timelines, and action items.
  • Performs tasks to support the project engineers with the development of processes and documentation for new or modified products.
  • Works with technicians on developing processes and documentation for new or modified products.
  • Develops and implements process improvements for current production products.
  • Troubleshoot production processes when part failures occur.
  • Track key programs and report out overall performance.
  • Create action plans that will drive improvement.
  • Coordinate and direct projects, making detailed plans to accomplish goals and directing the integration of technical activities.
  • Communicate with customers on process improvements and/or manufacturing changes.
  • Participates in the development of new products, work with customers to understand their requirements.
  • Lead small projects, including standard work.
  • Prepare periodic reports on project activities.
  • Assign tasks to engineers.
  • Provide support for contract review of new components.
  • Collaborate with the sales team to create new products.
  • Perform other responsibilities duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Incredible problem-solving abilities.
  • Interpersonal skills to manage a team on engineers.
  • Ability to meet deadlines and manage projects.
  • Ability to handle multiple projects at any given time.
  • Above average oral and written communication skills at all levels for technical personnel and customer contact.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities.
  • Willingness to travel, if required.
  • High ethical standards, good organizational skills
  • Demonstrated skills with project management tools, methodologies and problem solving.
  • Demonstrated success in leading and managing people in a team-based environment.
  • Must be able to read, write and speak fluent English.
  • Minimum Associates degree or equivalent experience. Preferred bachelor’s degree in an engineering discipline or equivalent.
  • Minimum 3 years of experience in manufacturing engineering.
  • Strong computer skills, including the MS Office suite.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Above average oral and written communication skills at all levels for technical personnel and client contact.
  • Ability to work independently using available resources.
  • Must have demonstrated organizational skills to manage multiple priorities and schedule revisions.
  • Must be able to use lean methodologies and drive a culture of change.

PHYSICAL DEMANDS:
While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT:
Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Pr. Engineer, Design Quality

Summary:

This position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.

Responsibilities:

  • This position may have direct-reporting responsibilities for daily activities of site Quality personnel (responsibility dependent on geographic organizational structure).
  • Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System.
  • Author and execute Quality Plans for Quality Product Design and Development projects.
  • Initiate and/or consult in the development and/or update of Risk Management and Hazard Analysis documentation in cooperation with cross-functional engineering teams per project requirements.
  • Develop and perform operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
  • Provide direction in implementing Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans.
  • Develop and justify appropriate sampling plans with characterization of test/inspection methods.
  • Author, review and/or approve documentation for Design Control activities for Design and Project Phase Reviews as well as Product Verification testing in cooperation with cross-functional engineering teams per project requirements.
  • Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
  • Represent Quality Engineering in design and phase reviews throughout the product development process.
  • Provide Leadership Engineering Technical Expertise and Guidance for site-level Quality functions.
  • Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NCMR’s.
  • Provide statistical data / trending analysis on CAPA, Complaint, NCMR and other quality metrics.
  • Support site customer-requested auditing activities (Customer and Regulatory Agencies).
  • Ensure compliance of all site personnel to Corporate and site-level QMS and training requirements.
  • Administration of employment practices, which includes, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees.  Responsible to ensure these actions are performed in compliance with Federal, local and organizational laws/policies.
  • Other duties and responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

Required Education & Experience:

  • Minimum 4-Year degree or equivalent of directly transferable industry work experience (Engineering or Quality discipline preferred).
  • Minimum of 2 years Leadership/Supervisory-level experience, with decision-making authority/responsibilities.
  • Minimum of 7 years’ experience in a regulated manufacturing environment.

Preferred Qualifications & Experience:

  • Advanced Post-Secondary Education/Training/Certification coursework
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Knowledge and experience with external standards:  ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.

Technical Requirements, Skills and Training:

  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.
  • Strong verbal and written English language communication skills.
  • Successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements.
  • Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

HR Manager

Summary:

The Human Resources Manager position is primarily responsible for supporting specific functions, working closely with management and employees on people-related issues: talent management, employee relations, coaching/development, compensation, conflict management, organizational development and more. The role of Human Resources Manager is instrumental in initiating, developing and driving HR programs/initiatives within specific functions aligned with the overall business strategy with considerable focus on scaling for growth and culture retention.

Human Resources Managers will plan, direct, and coordinate the administrative functions of the site and/or function’s they support. Human Resources Managers oversee the recruiting, interviewing, and hiring of new staff; consult with top executives on strategic planning; and serve as a link between an organization’s management and its employees.

Responsibilities:

  • Be a part of a dynamic HR team that works together closely to build culture, drive outcomes in the best interest of the business and enable our employees to be their best.
  • Writes directives advising department managers of Company policy regarding equal employment opportunities, compensation, and employee benefits.
  • Consults legal counsel to ensure that policies comply with federal and state law.
  • Develops and maintains a human resources system that meets top management information needs.
  • Oversees the analysis, maintenance, and communication of records required by law or local governing bodies, or other departments in the organization.
  • Identifies legal requirements and government reporting regulations affecting human resources functions and ensures policies, procedures, and reporting are in compliance. Studies legislation, arbitration decisions, and collective bargaining contracts to assess industry trends.
  • Recruits, interviews, tests, and selects employees to fill vacant positions.
  • Plans and conducts new employee orientation to foster positive attitude toward Company goals.
  • Coordinates management training in interviewing, hiring, terminations, promotions, performance review, safety, and sexual harassment.
  • Advises management in appropriate resolution of employee relations issues.
  • Administers performance review program to ensure effectiveness, compliance, and equity within organization. Administers salary administration program to ensure compliance and equity within organization.
  • Administers benefits programs such as life, health, and dental insurance, pension plans, vacation, sick leave, leave of absence, and employee assistance.
  • Conducts wage surveys within labor market to determine competitive wage rate.
  • Prepares employee separation notices and related documentation, and conducts exit interviews to determine reasons behind separations.
  • Prepares reports and recommends procedures to reduce absenteeism and turnover.
  • Contracts with outside suppliers to provide employee services, such as temporary employees, search firms, or relocation services.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BA/BS in related field.
  • Minimum 7 years of prior human resources management experience; multi-site experience desired.
  • Successful experience as an HR leader in a 400+ employee company aligned to an Engineering or Product client group.
  • A deep knowledge of HR programs and practices, including applicable state and federal employment laws and regulations.
  • Demonstrated analytical thinking, problem solving and decision-making skills.
  • Ability to listen and understand the needs of the employees, together with those of the company.
  • Ability to stylistically adapt communication based on audience.
  • Capability to respond effectively to the most sensitive inquiries or complaints.
  • Ability to write speeches and articles using original or innovative techniques or style.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.   The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT:

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Supply Chain Manager

Summary:

The Supply Chain Manager is responsible for management and execution of planning, purchasing, scheduling and materials management. The role drives continuous improvement in safety, reliability, cost, and team development. The role creates and leads teams while contributing directly to the success of multiple locations on site leadership teams. The Supply Chain Manager establishes and nurtures internal relationships to solve problems, drive improvement and successfully meet customer requirements. The role is responsible for ensuring business tool capabilities are leveraged fully. Strong team development and change management skills are required.

Responsibilities:

  • Serve on leadership teams to develop and execute business growth strategies
  • Develop and manage a multi-site, cross-discipline supply chain organization
  • Ensure smooth transfers to manufacturing during design transfer and insourcing efforts
  • Drive continuous improvement in supply planning and production scheduling
  • Provide change management leadership to formal and informal teams
  • Own on time delivery to Customers
  • Produce favorable total cost of ownership variances year over year
  • Drive improvement in cash flows through inventory velocity and customer- vendor- owned inventory programs
  • Establish and improve KPIs associated with supply chain functions such as schedule attainment, purchase price variance, inventory turns and accuracy, etc.
  • Improve supply planning accuracy — work with multiple departments to correct data used in ERP systems to effect step improvements targeting capacity utilization and constrained supply plans
  • Design and improve business processes to improve internal supply chain performance
  • Manage SIOP data including deployment of supply plans and development of capacity feedback models (RCCP)
  • Manage medium- and long-term improvement projects across functions and locations.
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Demonstrated supply chain management and improvement experience
  • Ability to solve problems and build consensus among teams
  • Strong leadership, communication, and change management skills
  • Experience leading and implementing SIOP/S&OP processes
  • A record of improving on time delivery through forecasting, supply planning, capacity planning, inventory, and production planning
  • Working knowledge and experience in Lean and Six Sigma methods
  • Experience implementing or improving ERP and QMS systems preferred
  • Logistics, procurement and warehouse management experience required
  • Experience operating in regulated industries – experience with ISO 9001 or ISO 13485.
  • Minimum of 5 years’ management experience in medical, pharmaceutical and or contract manufacturing
  • Bachelor’s degree, MBA preferred
  • Frequent travel between the Minnesota locations is required

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.   The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Manager Component Engineering

Summary:

This position is primarily responsible to provide functional supervision to the manufacturing engineering department. The ME Manager will assist production technicians and project engineers in defining and developing processes prior to introduction into standard production and lead process improvement efforts and day-to-day support of production products. Managing new components and contract review as these projects transition into operations.

Responsibilities:

  • Provide support & supervision to direct reports for the timely completion of projects, initiatives and key activities.
  • Mentor associates and foster a learning and growth environment.  Perform evaluations at regular intervals.
  • Provides in-put for the budget process.
  • Organize a project plans with required actions.
  • Track and communicate project status, plans, issues, timelines, and action items.
  • Performs tasks to support the project engineers with the development of processes and documentation for new or modified products.
  • Works with technicians on developing processes and documentation for new or modified products.
  • Develops and implements process improvements for current production products.
  • Troubleshoot production processes when part failures occur.
  • Track key programs and report out overall performance.
  • Create action plans that will drive improvement.
  • Coordinate and direct projects, making detailed plans to accomplish goals and directing the integration of technical activities.
  • Communicate with customers on process improvements and/or manufacturing changes.
  • Participates in the development of new products, work with customers to understand their requirements.
  • Lead small projects, including standard work.
  • Prepare periodic reports on project activities.
  • Assign tasks to engineers.
  • Provide support for contract review of new components.
  • Collaborate with the sales team to create new products.
  • Perform other responsibilities duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Incredible problem-solving abilities.
  • Interpersonal skills to manage a team on engineers.
  • Ability to meet deadlines and manage projects.
  • Ability to handle multiple projects at any given time.
  • Above average oral and written communication skills at all levels for technical personnel and customer contact.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities.
  • Willingness to travel, if required.
  • High ethical standards, good organizational skills.
  • Demonstrated skills with project management tools, methodologies and problem solving.
  • Demonstrated success in leading and managing people in a team-based environment.
  • Must be able to read, write and speak fluent English.
  • Minimum Associates degree or equivalent experience.  Preferred bachelor’s degree in an engineering discipline or equivalent.
  • Minimum 3 years of experience in manufacturing engineering.
  • Strong computer skills, including the MS Office suite.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Above average oral and written communication skills at all levels for technical personnel and client contact.
  • Ability to work independently using available resources.
  • Must have demonstrated organizational skills to manage multiple priorities and schedule revisions.
  • Must be able to use lean methodologies and drive a culture of change.

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

Work Environment:

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

VP/GM of Engineering Services

Summary:

The Vice President and General Manager (VP/GM) of Engineering Services is fully responsible for the P&L of the Global Engineering Services organization.  Engineering Services encompasses the business processes between customer proposals through design transfer of products to the Engineering Organization and is considered the growth vehicle of Cirtec Medical.  This position oversees an organization consisting of over 130 personnel across a wide range of program management, engineering disciplines, design quality and supply chain located at 5 different sites.  The VP and GM will maintain overall responsibility for new product development and improvement to existing product development activities; design and develop a differentiated product platform on time and within budget based on customer design specifications; accountable for the evaluation and implementation of timely and efficient project plans, product mapping, budget planning and anticipated product launches; supervise roadmaps and execution for technology development and product transfers.  Particular focus will be placed on customized product development and design-for-manufacturability, to meet the needs of customers. VP/GM will be an important member of the senior leadership team, playing a vital role in the development of company/corporate objectives and policies, and the achievement of business goals.

Responsibilities:

  • Drives the P&L of Global Engineering to ensure profitability goals are obtained.
  • Develop, execute and maintain short and long-term strategic plans in support of custom product development and existing company product improvements.
  • Immediately and continuously evaluate and develop methods, techniques, projects, and related programs to ensure on time and within budget achievement of corporate and departmental objectives.
  • Determine appropriateness of overall technology portfolio to achieve agreed objectives.
  • Contribute to the management of the patent portfolio; recommend priority for patent filings.
  • Provide strategic leadership and insight, ensuring the development and goal achievement of a highly effective engineering team.
  • Provide technical, logistical and planning guidance to resolve all product development issues.
  • Ensure cost effective measures and budget compliance; develop cost saving initiatives to meet or exceed financial performance requirements.
  • Partner cross-functionally in support of organizational goals and objectives.
  • Maintain knowledge of Good Manufacturing Practices (GMP), ISO-9000 and related regulations and Standard Operating Procedures (SOPs) as appropriate.
  • Ensure continual regulatory and quality compliance.
  • Maintain up-to-date knowledge of industry trends, new technologies, and competitor business; evaluate and adopt recent developments in appropriate scientific field for new product potential and improvement of existing products.
  • Other responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree (engineering, biomedical engineering, or related) required, with a related advanced degree preferred.
  • A minimum of fifteen (15) years previous progressive experience in manufacturing, product development and program management experience (at least five years’ experience at a senior leadership level).
  • Strong background and demonstrated results in a related “active implant” field (Neuromodulation, Cardiac Rhythm Management, etc.)
  • Demonstrated success in organizational development and driving results in a fast-growing enterprise
  • Experienced in budgeting, forecasting and driving improvement in financial performance with budgets in excess of $1 million required.
  • Record of successful late stage product development and subsequent product launch.
  • Superior communication skills and demonstrated negotiation abilities.
  • Superior knowledge and leadership skills with various project planning and management methodologies.
  • Strong focus on collaboration and teamwork.
  • Demonstrated success implementing projects or solving issues that significantly impact the overall success of an organization.
  • Must possess effective decision-making skills and analytical ability.

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

Work Environment:

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Test Station Engineer

Summary:

This position is primarily responsible for developing test code, writing test protocols, code, executing for active and passive implantable/external medical devices, mobile applications and embedded medical devices. Requires close communication with the product development team to track testing status, regression testing and documentation. This individual will work with a multi-disciplinary engineering team including software, electrical and mechanical hardware engineers and all other functions of the company to ensure high quality and on-time product introductions. This team player will have experience with multi-tasking in a high energy fast paced environment. The person needs to have strong self-starting qualities to independently manage coordination of multiple projects to ensure timely and successful completion. Must be enthusiastic, positive, even tempered and have strong skills in areas of dependability, interpersonal relationships, communication, organizational, flexibility and professional.

Responsibilities:

  • C# and UI development experience to create programs for medical device production floor operators
  • M2M and SQL databases
  •  Create interfaces to MICS base stations and implants
  • Create, review test software requirements, architecture, develop and executing the test code
  • Develop user and system documentation
  • Participate in product development meetings and software/hardware design and risk analysis reviews
  • Experience in creating and executing test cases and scripts to verify software and hardware requirements
  • Working knowledge of testing active and passive implantable/external medical devices; mobile applications and embedded medical devices
  • Specify and assemble hardware for test station
  • Ensure that medical device components are compliant with applicable international standards and requirements
  • Maintain software/hardware design history file and participate in periodic phase reviews
  • Report defects to the stakeholders and create test logs
  • Provide inputs to the team in order to improve the medical device design and test outcomes
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • 5-7 years’ experience in testing active implantable devices, hand-held devices and test equipment used for testing medical devices.
  • Working knowledge in electronics; analog, power and digital, oscilloscopes, general electronic test equipment.
  • Knowledge of Quality Control principles and methodology is an asset
  • Good Communication and interpersonal skills
  • Analytical reasoning and problem solving
  • Experience in developing test code instructions and procedures
  • C#, LabVIEW, National Instruments TestStand, SQL
  • Develop user, system and process documentation IQ, OQ, PQ
  • Agile development, scrum master
  • Familiarity with medical development standards such as IEC 60601-1, 62304, 60601-1-2,  ISO 14708-1, 14708-3
  • Excellent oral, written, and presentation communication skills
  • Bachelor’s Degree preferable in Electrical/Electronic/Biomedical/Computer Engineering or extensive professional experience in AIMD testing
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Manager, Development Quality

Responsibilities:

  • Manage the validation and design quality engineering team to provide strategic direction for Quality Assurance of Medical Devices.
  • This role works closely with hardware and software development teams to ensure quality compliant products.
  • Works with process development teams to ensure robust validation activities occur in a timely manner.
  • Oversee the review and approval of validation packages and design control related documentation generated on site such that the Quality Records comply with site and regulatory requirements.
  • Establish service level agreements to ensure timely completion and monitor teams performance in support of the sites validation, design control and on market change projects to ensure best speed to market for new/changed products.
  • Participate in the progress of failure/quality investigations and CAPAs associated with site validation and design control activities.
  • Implement and maintain site change, validation and design control activities through management of the Validation & Design Control QA group and interaction with the groups that execute such tasks.
  • Ensure that members of the department stay current on the requirements, practices, and training of the validation and design control regulations and guidance documents.
  • Ensure the expertise and material is available to be able to deploy change, validation and design control training to the site.
  • Work with Quality peers to ensure the development of consistent, best practice validation and design control policies and procedures.
  • Manage the Validation & Design QA budget to ensure spending is within agreed limits.
  • Maintain awareness of financial performance.
  • Support the development of cost-efficient business processes whilst ensuring compliance and quality requirements are met.
  • Take responsibility for financial planning of Validation & Design QA for future budget cycles.
  • Other duties and responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • Minimum 4-Year degree or equivalent of directly transferrable work experience (Engineering discipline preferred).
  • Quality and/or Regulatory certification(s) preferred (ASQ, RAPS, etc.).
  • Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDR, TGA, MHW, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPA and customer complaints.
  • Experience in effectively managing audits by customers and regulatory agencies.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
  • Experience with the preparation, review and catalogue of SOPs, Work Instructions and other Quality Systems documents.
  • Strong verbal and written communication skills. Ability to present complex data to internal and external contacts.
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines, while increasing employee engagement and retention.
  • Experience with the preparation of Engineering protocols & reports.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Wire EDM Programmer

Responsibilities:

  • Produces Wire EDM programs for the Wire EDM machines and Hole Popper ensuring that programs are error free, produced timely, and user friendly
  • Inspects completed components for size, squareness, and location accuracy
  • Maintains WEDM print control through updates of programs at the end of die build and deletions of obsolete prints and programs
  • Responsible for the maintenance of the Wire EDM filing system
  • Works with the Wire EDM Director, Designer and Tool Room to maintain WEDM preparation standards
  • Provides electronic design data in the most efficient manner for design updating. Works with the Wire EDM Director and Designer
  • Troubleshoots, maintains, and corrects minor problems with the Wire EDM. Assists with the measuring and cutting of parts
  • Serves as back up to the Wire EDM Director
  • Pro-actively pursues continuing education and personal development opportunities in area of expertise
  • Follows all Company and ISO procedures. Maintains procedures as assigned. Actively participates in continuous improvement initiatives
  • Promotes a SAFE and positive work environment
  • Supports activities required to implement and maintain the Company’s strategic and departmental objectives
  • Keeps abreast of latest in technology regarding area of expertise. Makes recommendations to implement, where feasible
  • Effectively communicates with other departments, supervisors, and managers, including participation in meetings as required
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • High school diploma or equivalent
  • Completion of a tool and die making apprenticeship program or a combination of four to five years of trade school, tool and die making courses and related experience or equivalent
  • Experience in Job Boss and internet skills
  • Proficient in the use and setting of variables and their interpretation and application in the programming of Wire EDM programs
  • Accepts responsibility and accounts for own actions
  • Maintains high ethical standards
  • Able to get along well with a variety of personalities and individuals
  • Able to learn and apply new technology
  • Uses thinking and reasoning to solve problems
  • Excellent customer service while following company procedures
  • Demonstrated ability for systematic problem solving
  • Identifies and resolves problems in a timely manner
  • Must be able to make clear and accurate decisions

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Design & Development Quality Engineer

Summary:

The position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.

Responsibilities:

  • Design Input/ Output Characterization & Specification
  • Manufacturing Process Verification & validation Controls
  • Gage R&R, Test/Inspection Method Development & Qual.
  • Statistical Qualitative and Quantitative Data Analysis
  • Complaints Investigation/Returned Materials Analysis
  • Manufacturing Engineering support
  • Education & Training
  • ISO Class Controlled Environments
  • Metrology & Calibration (including Gage R&R)
  • Tracking and Trending Quality Objectives and Metrics,
  • Other Quality Management System Functions

This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.

Requirements:

Educational: 

  • Associate/Bachelor of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly-transferable industry work experience (Engineering or Quality discipline preferred).

Technical: 

  • Minimum of 2-5 years of experience in a regulated manufacturing environment.
  • Experience with medical device design and manufacturing requirements, specifically in the areas of design control and design transfer for manufacturing/production.
  • Demonstrable knowledge and experience with Design Assurance tools/methodologies including: Design Controls, Design Change Assessment, Risk Management (Hazard Analysis), Design and Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation.
  • DFx / DFm / DFr knowledge and experience preferred.
  • Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDD, TGA, MHLW, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPAs and customer complaints.

Skills: 

  • Strong verbal and written English language communication skills, including experience in technical protocol and report writing.
  • Ability to work with cross-functional groups and teams including R&D, Manufacturing, and QA as required working collaboratively to accomplish results with minimal guidance.
  • “Hands-on” self-starter with ability to work both independently and as part of a team.

Training: 

  • Training or equivalent work experience with general computer use and software applications (e.g. Microsoft Word, Excel, Power Point, Visio and Access).
  • Experience with statistical software tools (i.e. Minitab) experience preferred.
  • Must be able to drive and implement quality initiatives, interpret collected data, and present the data to multiple levels of management as part of continuous improvement / continuation engineering activities.

Performance: 

  • Interaction: Capability to present information in public speaking forums including, but not limited to, the ability to meet with external agencies and clients/customers, as required/desired.
  • Initiative: Capability to function independently without supervision.
  • Leadership: Capability to effectively lead and initiate discussions and meetings with Sr. Management staff and team.
  • Analytical Problem Solving: Capability to employ systematic and logical approached to problem-solving and develop and execute plans to take action/make adjustments.
  • Team Player: Must be able to work and thrive in a team environment.
  • Effective Communication: Excellent verbal and written communication skills and the capability to interface and communicate ideas, concepts, challenges and solutions with staff, cross-functional peers and personnel effectively.
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Chandler, AZ

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Opportunities in Enfield, CT

Quality Engineer-Design & Development

Summary:

This position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.

Responsibilities:

  • Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System.
  • Author and execute Quality Plans for Quality Product Design and Development projects.
  • Initiate and/or consult in the development and/or update of Risk Management and Hazard Analysis documentation in cooperation with cross-functional engineering teams per project requirements.
  • Establish severity and risk-based Design Verification and Process Master Validation Plan strategies with appropriate V&V rationales.
  • Support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
  • Drive Test Method development (w/ Operational and Business considerations) and execution of Test Method Validations to measure effectivity.
  • Provide direction in implementing Incoming, In-Process and Final Product Inspection plans.
  • Develop and justify appropriate sampling plans with characterization of test/inspection methods.
  • Champion First Article Inspections and Component Qualifications.
  • Author, review and/or approve documentation for Design Control activities for Design and Project Phase Reviews as well as Product Verification testing in cooperation with cross-functional engineering teams per project requirements.
  • Represent Quality Engineering in design and phase reviews throughout the product development process.
  • Support initial qualification audit activities (Customer and Regulatory Agencies).
  • Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
  • Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NCMR’s, as applicable.
  • Ensure compliance of all site personnel to Corporate and site-level QMS and training requirements.
  • Administration of employment practices, which includes, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees. Responsible to ensure these actions are performed in compliance with Federal, local, and organizational laws/policies.
  • Other duties and responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

Required Education & Experience:

  • Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).
  • Minimum of 2-5 years’ experience in a regulated manufacturing environment.

Preferred Qualifications & Experience:

  • Advanced Post-Secondary Education/Training/Certification coursework.
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.)
  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.

Technical Requirements, Skills and Training:

  • Experience in effectively supporting audits by customers and external regulatory agencies.
  • Strong verbal and written English language communication, organizational, and management skills.
  • Successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements.
  • Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

2nd SHIFT-Technician I

Summary:

This position is primarily responsible for manufacturing processing, inspection, standard documentation and packaging of products. The Technician I works under the direction of the Production Team Leader and the upper level Technicians they are assigned to assist or be trained by.  This position is designed to augment the ability of the Technician’s and other manufacturing personnel to meet goals for quality and production rates in a cost-effective manner.

Responsibilities:

  • Primary function of assisting production operators and technicians engaged in processing and product fabrication.
  • Will be proficient in the task of loading components into product specific tools.
  • Demonstrates strict adherence to all safety, GMP & quality system guidelines.
  • Has the responsibility of following established documentation for product manufacturing.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre-weld operations such as assembly and part cleaning.
  • Performs various post-weld operations such as cleaning or post weld assembly.
  • Assists in packaging of finished goods as needed.
  • Maintains cleanliness of work areas, machines, tools and equipment.
  • Assists Quality Control with inspection duties as required.
  • Performs other duties as assigned by the Production Manager.
  • Takes direction within the manufacturing cell from upper level Technicians assigned to that cell.
  • Performs workstation set-ups with assistance from qualified technicians.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Must be able to read, write and speak fluent English.
  • High school diploma or General Education Degree (GED) is required.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

NPI Buyer

Summary:

The New Program and Product Introduction Buyer is responsible for sourcing, selection and development of vendors in support of strategic projects and programs. The NPI Buyer will lead sourcing efforts during the design and development process of new and existing medical devices and device components. The role requires effective communication and collaboration with project and program teams as well as external partners and vendors. Strong multitasking skills required to ensure all program deliverables are completed successfully.

Responsibilities:

  • Responsible for vendor selection, qualification and development.
  • Quote and procure components, services and equipment required for assigned projects and programs.
  • Develop strong relationships with vendors to ensure quality and delivery at best in class costs.
  • Establish and improve purchasing and planning parameters (lead times, MOQ’s, tiers and pricing).
  • Ensure vendor performance supports design requirements and production goals.
  • Review MRP to verify accurate demands and to place orders for inventory components on a timely basis.
  • Transition production ready vendors, supplies, and services to sustaining buyers.
  • Support project and program teams as key sourcing and supply chain resource.
  • Work with Engineering to review new item masters to ensure compliance with finance, inventory and purchasing guidelines.
  • Execute other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Demonstrated supply chain creation, management, and improvement experience.
  • A record of creating and improving vendor relationships.
  • Demonstrated experience in technical sourcing resulting in improved quality, delivery, cost and inventory turnover.
  • Ability to read and interpret technical specifications, prints and requirements.
  • Experience in ASIC, PCBA, and related supply chains a plus.
  • Minimum of 5 years’ experience in contract and or medical device manufacturing with demonstrated progressive sourcing experience.
  • Bachelor’s degree preferred.
  • Working knowledge and experience in Lean and Six Sigma methods, ERP and QMS systems, and logistics and procurement processes.
  • Experience with ISO 9001 and ISO 13485 procedures preferred.
  • Execute other duties as assigned.

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Supply Chain Manager

Summary:

The Supply Chain Manager is responsible for management and execution of planning, purchasing, scheduling and materials management. The role drives continuous improvement in safety, reliability, cost, and team development. The role creates and leads teams while contributing directly to the success of multiple locations on site leadership teams. The Supply Chain Manager establishes and nurtures internal relationships to solve problems, drive improvement and successfully meet customer requirements. The role is responsible for ensuring business tool capabilities are leveraged fully. Strong team development and change management skills are required.

Responsibilities:

  • Serve on leadership teams to develop and execute business growth strategies
  • Develop and manage a multi-site, cross-discipline supply chain organization
  • Ensure smooth transfers to manufacturing during design transfer and insourcing efforts
  • Drive continuous improvement in supply planning and production scheduling
  • Provide change management leadership to formal and informal teams
  • Own on time delivery to Customers
  • Produce favorable total cost of ownership variances year over year
  • Drive improvement in cash flows through inventory velocity and customer- vendor- owned inventory programs
  • Establish and improve KPIs associated with supply chain functions such as schedule attainment, purchase price variance, inventory turns and accuracy, etc.
  • Improve supply planning accuracy — work with multiple departments to correct data used in ERP systems to effect step improvements targeting capacity utilization and constrained supply plans
  • Design and improve business processes to improve internal supply chain performance
  • Manage SIOP data including deployment of supply plans and development of capacity feedback models (RCCP)
  • Manage medium- and long-term improvement projects across functions and locations.
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Demonstrated supply chain management and improvement experience
  • Ability to solve problems and build consensus among teams
  • Strong leadership, communication, and change management skills
  • Experience leading and implementing SIOP/S&OP processes
  • A record of improving on time delivery through forecasting, supply planning, capacity planning, inventory, and production planning
  • Working knowledge and experience in Lean and Six Sigma methods
  • Experience implementing or improving ERP and QMS systems preferred
  • Logistics, procurement and warehouse management experience required
  • Experience operating in regulated industries – experience with ISO 9001 or ISO 13485.
  • Minimum of 5 years’ management experience in medical, pharmaceutical and or contract manufacturing
  • Bachelor’s degree, MBA preferred
  • Frequent travel between Enfield, CT and Lowell, MA

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.   The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Shipper/Receiver

Summary:

This position is primarily responsible for the shipping and receiving of materials, verifies and maintains accurate records of incoming and outgoing shipments according to company’s Quality System Procedures, assists with inventory control and management,  performs cycle counting, kits and issues materials to production job orders, and orders production consumable supplies as required.

Responsibilities:

  • Receive customer supplied and/or purchased materials.  This includes proper labeling, storage and documenting movement of materials.
  • Unpack, examine and route incoming shipments, reject damaged items and record shortages.
  • Performs ERP transactions necessary to track movement of goods prior to acceptance into inventory.
  • Generate required documentation for domestic and international shipments.
  • Monitor inventory levels of production consumables and place orders as necessary.
  • Maintain adequate inventory of shipping materials and supplies.
  • Place orders for R&D materials as assigned.
  • Receive and process all defective products returned for repair, investigation or credit.
  • Schedules Shipper/Courier pickups as required.
  • Maintain the work area and equipment in a clean and orderly condition.
  • Follow prescribed Safety Regulations.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High School Diploma.
  • Minimum of 3-5 years shipping/receiving experience preferably in a regulated industry.
  • Fluent and literate in English.
  • Experience with computers and computer software programs. (i.e. FedEx application)
  • Ability to read and interpret technical documentation.
  • Capacity to work well under pressure and take on new challenges.
  • Organizational and time management skills.
  • Ability to work to tight deadlines.
  • Awareness of health and safety issues as they relate to the device manufacturing.
  • Ability to work independently using available resources.
  • Previous experience with FDA standards, ISO 13485 and GMP principles.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is required to stand, and/or walk.  The employee must occasionally lift and/or move up to 30 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Quality Engineer-Design & Development

Summary:

This position is primarily responsible for Design Control (product development), Regulatory compliance, qualitative and quantitative data analysis, complaint investigation and analysis, Manufacturing support, Training, Metrology and Gage R&R, and other Quality functions. Additionally, this role is expected to provide input and contribute on Quality System strategies and approach.

Responsibilities:

  • Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System.
  • Author and execute Quality Plans for Quality Product Design and Development projects.
  • Initiate the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments per project requirements.
  • Establish severity and risk-based Design Verification and Process Master Validation Plan strategies with appropriate V&V rationales.
  • Support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
  • Drive Test Method development (w/ Operational and Business considerations) and execution of Test Method Validations to measure effectivity.
  • Provide direction in implementing Incoming, In-Process and Final Product Inspection plans.
  • Develop and justify appropriate sampling plans with characterization of test/inspection methods.
  • Champion First Article Inspections and Component Qualifications.
  • Author, review and/or approve documentation for Design Control activities for Design and Project Phase Reviews as well as Product Verification testing in cooperation with cross-functional engineering teams per project requirements.
  • Represent Quality Engineering in design and phase reviews throughout the product development process.
  • Support initial qualification audit activities (Customer and Regulatory Agencies).
  • Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
  • Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NCMR’s, as applicable.
  • Ensure compliance of all site personnel to Corporate and site-level QMS and training requirements.
  • Administration of employment practices, which includes, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees.  Responsible to ensure these actions are performed in compliance with Federal, local, and organizational laws/policies.
  • Member of customer and 3rd party quality audit team.  May be required to lead this effort.
  • Provide Engineering Technical Expertise and Guidance for site-level Quality functions.
  • Other duties and responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

Required Education & Experience:

  • Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).
  • Minimum of 4-6 years’ experience in a regulated manufacturing environment.

Preferred Qualifications & Experience:

  • Advanced Post-Secondary Education/Training/Certification coursework.
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.)
  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Knowledge and experience with external standards:  ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.

Technical Requirements, Skills and Training:

  • Experience in effectively supporting audits by customers and external regulatory agencies.
  • Strong verbal and written English language communication, organizational, and management skills.
  • Successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements.
  • Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.
  • Demonstrated use of Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, and Gauge R&R.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Engineer

Summary:

This position is primarily responsible for developing and implementing robust cost-effective manufacturing processes and methods in accordance with product specifications and Class III medical device quality standards.  This position recommends and implements improvements to sustained production processes, methods and controls; as well as coordinates the launch of new products into pilot production.

Responsibilities:

  • Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
  • Prepares engineering change orders and coordinates the deployment of changes including training operation team members.
  • Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
  • Coordinates the manufacturing launch of new products including establishing yield targets, run rates, training needs and evaluating results.
  • Develop and qualify various tools and equipment required for manufacturing processes.
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
  • Utilizing tools associated with risk management (e.g. PFMEA) to identify potential risks and the associated corrective actions.
  • Supporting required equipment qualification and process validations (IQ, OQ and PQ).
  • Troubleshoot manufacturing processes when defects occur.  Determine root cause and implement effective containment and countermeasures.
  • Disposition non-conforming products and develop re-work procedures.
  • Communicate with customers regarding process improvements and production changes.
  • Represent manufacturing on cross functional teams.
  • Participate in Kaizen events and drive continuous improvement efforts.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree in Engineering or related field
  • Knowledge of manufacturing and assembly processes
  • Excellent verbal and written communication skills
  • Fluency in English
  • Minimum 2-5 years of experience with Class II or III Medical devices, FDA standards, ISO 13485 and GMP principles.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Association with supporting documents including, ECN’s, process deviation, non-conformances, stop shipment notifications and all associated quality related documents.
  • Strong computer skills associated with MS Office suite, Minitab and SolidWorks a plus.
  • Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles.
  • The ability to understand a range of engineering functions and procedures.
  • Interpersonal, presentation and communication skills.
  • The capacity to work well under pressure and take on new challenges.
  • Organizational and time management skills.
  • Project management skills and the ability to work to tight deadlines

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Process Development Engineer

Summary:

This position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients on projects of moderate complexity.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets.
  • Provide guidance and direction to coworkers on areas of technical expertise.
  • Troubleshoot production processes as required.
  • Evaluate and select appropriate test methods for product requirements.
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection
    • Process development and documentation
    • Device Verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process Validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging.
    • Materials sourcing and device prototyping.
    • Design verification and validation activities, including data for regulatory submission
    • Manufacturing transfer and support of existing product lines as applicable.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Willingness to travel, if required.
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills.
  • Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures.
  • Must be able to read, write and speak fluent English.
  • A Bachelors’ degree in an engineering discipline with 5 years of relevant experience; Associates degree in an engineering discipline w/10 years of relevant experience; or equivalent.
  • Experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents.
  • Strong analytical skills, must be able to obtain and evaluate secondary research information.
  • Ability to learn and apply new technology.
  • Moderate knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Process & Development Engineering Technician

Summary:

This position is primarily responsible to develop and improve assembly operations or in an effort to improve productivity, yield and process flow. Must provide excellent trouble shooting ability on equipment and assembly fixturing. Assist Manufacturing Engineer to develop new processes, documentation, perform experiments and develop tooling/fixturing as needed.

Responsibilities:

  • Develop processes and documentation in support of new and existing components and assemblies to include clean room assembly, machining, coiling, and laser processing support.
  • Active participation in improving quality and processes for the products we manufacture. Focusing on the clean room.
  • Excellent working knowledge of blueprint and geometric tolerances.
  • Understand and promote good manufacturing practices (GMPs) including all clean room related requirements.
  • Assist in training employees on equipment and assembly skills.
  • Interact effectively and assist engineering in improving quality and solving problems.
  • Work with tooling engineer to design fixtures for procedures developed.
  • Show self-motivation to optimize job performance on a continual basis.
  • Evaluate alternative manufacturing methods.
  • Maintain a clean and orderly work area.
  • Ability to diagnose and solve problems with jobs in a timely manner.
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • 3-5 years’ experience in a medical device clean room assembly environment. Includes, but not limited to working with different bonding agents, such as epoxies, UV adhesives & silicones. Also, familiarity with operations such as laser welding, crimping, swaging, thermoforming, annealing and general mechanical assembly.
  • Knowledge of laser operation.
  • Excellent working knowledge of blueprint and geometric tolerances.
  • Strong Problem solving and process validation experience.
  • Experience running all types of CNC machines is a plus, but not required.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Site Quality Manager

Summary:

This position will be responsible for the Leadership and management of all site-level Quality-organizational personnel and resources to ensure adherence and compliance to Cirtec Medical’s Quality Management System. The Site Quality Manager shall be the designated Site-Level Management Representative for the Quality Management System of their assigned Cirtec Medical Facility.

Responsibilities:

  • This position may have multiple direct-reporting subordinate Managers and Supervisors in addition to having direct-reporting responsibilities for daily activities of site Quality personnel (responsibility dependent on geographic organizational structure).
  • Designated Site-level Management Representative for assurance of compliance to the Cirtec Medical Quality Management System and member of the Site-Senior Management Team for the facility.
  • Drive and Support Corporate QMS initiatives and continuous improvement activities.
  • Ensure establishment and maintenance of site regulatory registrations (ISO 13485, FDA, etc.).
  • Provide organizational Quality Leadership, coaching, mentoring and guidance to all Quality personnel as well as cross-functional teams.
  • Support for integration of new manufacturing capabilities, product transfers, development programs and manufacturing customers.
  • Provide Leadership and Guidance for site-level Quality functions including Documentation Control and records retention, Complaint Handling/Returns, Corrective and Preventive Actions, Training, Supplier Quality Management, Nonconforming Material Handling, and Metrology/Calibration Control Systems.
  • Provide oversight and ensure compliance of Quality System support elements for the site QMS: Internal Auditing, Supplier Quality Management, Complaint Handling, Corrective and Preventive Actions, Nonconforming Materials Controls; and the tracking & reporting of associated metrics.
  • Act as site-level Champion for Quality Best Practices and GDP/GMP continuous improvement efforts.
  • Provide Leadership and Guidance for site-level Quality functions including incoming (Receiving & Inspection), in-process inspection, final inspection, and product release support.
  • Provide Leadership and Guidance for site-level Design and Development programs, Sustained Manufacturing and Continuous Improvement/Continuation Engineering activities and initiatives.
  • Provide Leadership and Guidance for Risk Management (Hazard Analysis and Assessment – Design & Process), Design and Limit Characterization, and Process Qualification (DV&V and PV).
  • Oversee and coordinate site auditing activities (Customer and Customer Regulatory Agencies).
  • Ensure compliance of all site personnel to Corporate and site-level QMS and training requirements.
  • Administration of employment practices, including, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees. Responsible to ensure these actions are performed in compliance with Federal and local laws as well as Cirtec Medical policies.
  • Must adhere to professional workplace attire, time, attendance and leave of absence policies.
  • Other duties and responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

Required Education & Experience:

  • Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).
  • Minimum of 4 years Leadership/Supervisory-level experience, with budget and decision-making authority/responsibilities.
  • Minimum of 6 years’ experience in a regulated manufacturing environment.

Preferred Qualifications & Experience:

  • Advanced Post-Secondary Education/Training/Certification coursework
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.

Technical Requirements, Skills and Training:

  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.
  • Strong verbal and written English language communication skills.
  • Successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements.
  • Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Los Gatos, CA

Software (Embedded) Engineer

Summary:
Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

Based out of our facility in Los Gatos, CA, The Sr. Software (Embedded) Engineer will be mainly responsible for development and integration of embedded software for novel Class II and Class III medical devices.

Responsibilities:

  • Design, implementation and testing of embedded software
  • Participate in software system architecture development and document software requirements and development plan
  • Perform detailed design analysis and reviews with hardware engineering team to achieve product performance, cost, reliability and manufacturability requirements
  • Track software related issues and lead resolution of issues with a well-documented and methodical approach
  • Develop software test and verification plans and protocols, and conduct prototype testing and verification testing
  • Work closely with hardware engineering team to debug/integrate software with hardware
  • Collaborate with program managers to create and manage development plans and project plans related to software development
  • Develop and contribute towards creation of software design history file, risk management documentation, issue tracking, configuration management, etc.
  • Develop and maintain relevant documentation (for e.g. specifications, designs, test plans and reports, etc.) required for medical product Design History Files
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS in Electronics or Computer Engineering or in an equivalent engineering discipline.
  • Minimum 2 years of experience in embedded software development in the medical device industry or a highly regulated industry
  • Experience with ARM Cortex-A9, TI MSP, PIC or, DSP Processors
  • Extensive experience programming in C and C++
  • Strong HW / SW bring-up and debugging skills
  • Capable of working independently in a hardware lab with oscilloscopes, signal generators, power supplies and other test equipment.
  • Knowledge and understanding of IEC 62304, FDA guidance for medical device development and other relevant medical device regulatory standards highly preferred but not mandatory.
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT
Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Software (Embedded) Engineer

Summary:

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

Based out of our facility in Los Gatos, CA, The Sr. Software (Embedded) Engineer will be mainly responsible for development and integration of embedded software for novel Class II and III medical devices.

Responsibilities:

  • Lead and coordinate design, implementation and testing of embedded software
  • Participate in software system architecture development and document software requirements and development plan
  • Perform detailed design analysis and reviews with hardware engineering team to achieve product performance, cost, reliability and manufacturability requirements
  • Track software related issues and lead resolution of issues with a well-documented and methodical approach
  • Develop software test and verification plans and protocols, and conduct prototype testing and verification testing
  • Work closely with hardware engineering team to debug/integrate software with hardware
  • Collaborate with program managers to create and manage development plans and project plans related to software development
  • Lead and contribute towards creation of software design history file, risk management documentation, issue tracking, configuration management, etc.
  • Develop and maintain relevant documentation (for e.g. specifications, designs, test plans and reports, etc.) required for medical product Design History Files
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS in Electronics or Computer Engineering or in an equivalent engineering discipline.
  • 10+ years’ experience in embedded software development in the medical device industry or a highly regulated industry
  • Experience with ARM Cortex-A9, TI MSP, PIC or, DSP Processors
  • Extensive experience programming in C and C++
  • Strong HW / SW bring-up and debugging skills
  • Cyber security / safe boot loader experience
  • Capable of working independently in a hardware lab with oscilloscopes, signal generators, power supplies and other test equipment.
  • Knowledge and understanding of IEC 62304, FDA guidance for medical device development and other relevant medical device regulatory standards highly preferred but not mandatory.
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Engineer

Summary:

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

Based out of our facility in Los Gatos, CA, the Manufacturing Engineer will be mainly responsible for manufacturing process development, launching new products into clinical and/or pilot production and supporting sustained production.

Responsibilities:

  • Develops and implements robust cost-effective manufacturing processes, and improves product flow and product quality and safety performance for both sustained and new products
  • Leads design transfer of new products to production including establishing assembly time and yield targets, training needs and quality control
  • Develops, tests and implements tools, fixtures and equipment required for manufacturing processes
  • Develops manufacturing process instructions, inspection plans and lot history travelers
  • Leads creation of manufacturing process validation plans, validation protocols and reports, and implements manufacturing process validations and test method validations
  • Collaborates with cross-functional teams during development phase(s), and provides inputs and recommendations for design for manufacturability (DFM)
  • Develops and maintains process risk documentation (e.g. PFMEA) to identify potential risks, and implement preventive and corrective actions
  • Manages and/or supports production and test equipment maintenance, qualification and calibration
  • Performs analysis for cost reduction, and quality and efficiency improvement
  • Prepares engineering change orders and coordinates the implementation of changes including training production staff
  • Troubleshoots designs and processes when defects occur, leads investigation to determine root cause and implements effective containment and counter measures
  • Dispositions non-conforming products and develops required re-work procedures
  • Communicates with customers regarding process improvements and production changes
  • Perform other responsibilities duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS in Mechanical / Industrial Engineering or in an equivalent engineering discipline
  • 5+ years of experience in medical device process development and/or manufacturing engineering
  • Experience with capital electromechanical products (involving circuit boards and displays) preferred
  • Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies preferred
  • Solid knowledge of GMP and ISO 13485 regulations
  • Must be able to review and interpret technical drawings and specifications. Proficiency in Solidworks preferred.
  • Strong computer skills, including the MS Office suite
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
  • Must have demonstrated organizational skills to manage multiple priorities and schedules

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Lowell, MA

Sr. Design & Development Quality Engineer

Summary:

This position is primarily responsible for Design Control (product development), Regulatory compliance, qualitative and quantitative data analysis, complaint investigation and analysis, Manufacturing support, Training, Metrology and Gage R&R, and other Quality functions. Additionally, this role is expected to provide input and contribute on Quality System strategies and approach.

Responsibilities:

  • Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System.
  • Author and execute Quality Plans for Quality Product Design and Development projects.
  • Initiate the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments per project requirements.
  • Establish severity and risk-based Design Verification and Process Master Validation Plan strategies with appropriate V&V rationales.
  • Support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
  • Drive Test Method development (w/ Operational and Business considerations) and execution of Test Method Validations to measure effectivity.
  • Provide direction in implementing Incoming, In-Process and Final Product Inspection plans.
  • Develop and justify appropriate sampling plans with characterization of test/inspection methods.
  • Champion First Article Inspections and Component Qualifications.
  • Author, review and/or approve documentation for Design Control activities for Design and Project Phase Reviews as well as Product Verification testing in cooperation with cross-functional engineering teams per project requirements.
  • Represent Quality Engineering in design and phase reviews throughout the product development process.
  • Support initial qualification audit activities (Customer and Regulatory Agencies).
  • Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
  • Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NCMR’s, as applicable.
  • Ensure compliance of all site personnel to Corporate and site-level QMS and training requirements.
  • Administration of employment practices, which includes, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees.  Responsible to ensure these actions are performed in compliance with Federal, local, and organizational laws/policies.
  • Member of customer and 3rd party quality audit team.  May be required to lead this effort.
  • Provide Engineering Technical Expertise and Guidance for site-level Quality functions.
  • Other duties and responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

Required Education & Experience:

  • Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).
  • Minimum of 4-6 years’ experience in a regulated manufacturing environment.

Preferred Qualifications & Experience:

  • Advanced Post-Secondary Education/Training/Certification coursework.
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.)
  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Knowledge and experience with external standards:  ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.

Technical Requirements, Skills and Training:

  • Experience in effectively supporting audits by customers and external regulatory agencies.
  • Strong verbal and written English language communication, organizational, and management skills.
  • Successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements.
  • Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.
  • Demonstrated use of Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, and Gauge R&R.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Senior Manager, Operations

Summary:

This position is responsible for the management of production and engineering management all assembly operations and related support functions, production planning, equipment maintenance functions, formulating and recommending manufacturing policies and programs. Create and direct a team-oriented workforce to achieve and / or exceed employee and customer satisfaction, business and profit objectives, including continuous improvement within areas of safety, reliability, cost savings, team building and personnel management. Develop and implement business plans and programs in a manner that aligns with identified objectives.

Responsibilities:

  • Establish, monitor and improve KPIs associated with the manufacturing facility such as lead times, inventory turns, labor efficiency and on-time delivery.
  • Collaborate with cross-functional partners to achieve annual site operational goals.
  • Develop plans to improve business processes related to Supply Chain management practices associated to planning, purchasing and materials management.
  • Manage the S&OP data associated to assigned facility — create a comprehensive process for communicating data for the S&OP meetings.
  • Hire, develop and manage the performance of a cross-discipline supply chain organization.
  • Manage cross-functional projects as assigned.
  • Execute other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree.
  • Demonstrated supply chain planning improvement experiences.
  • Strong leadership, communication, and change management skills across multiple discipline of supply chain or operations.
  • Minimum of 10 years’ experience in contract or medical device manufacturing.
  • A record of improving forecasting, supply planning, capacity planning, inventory, and production planning.
  • Working knowledge and experience in Lean and Six Sigma methods, implementation of ERP and QMS systems, logistics and procurement processes, and warehouse management is required.
  • Experience with and managing with ISO 9001 and 13485 procedures preferred.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Buyer/Planner

Summary:

The Buyer Planner creates and owns material plans in support of production needs. The Buyer Planner generates purchase orders and manages supplier deliveries. The Buyer Planner is responsible for the availability and flow of produced and purchased materials.

Responsibilities:

  • Create, maintain, and improve material and production plans and schedules
  • Plan and execute purchase orders to support production plans and financial goals
  • Drive improvements in schedule attainment and inventory velocity
  • Establish and maintain secure and dependable relationships with internal and external suppliers
  • Ensure best in class service and pricing from preferred suppliers
  • Other responsibilities as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Demonstrated purchasing and supplier management background
  • Experience in planning and scheduling techniques to drive on time delivery to Customers
  • Understanding of ERP/MRP based planning systems and lean manufacturing principles
  • 3 – 5 years relevant manufacturing experience required in medical, pharma and or similarly regulated industries
  • Bachelor’s degree and or APICS/ASCM certification
  • Knowledge of Supply Chain Management concepts and processes
  • Strong interpersonal communication skills including in-person and virtual

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position. Occasional overnight travel may be required up to twenty percent.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Industrial Engineer-Continuous Improvement

Summary:

The Industrial Engineering (IE) role in the Operational Excellence group is a key member of the organization. The IE is responsible for identifying and leading execution of a wide range of Continuous Improvement projects using industry best practices in Lean and Six Sigma approaches.  He/she leads, facilitates, executes, and manages team training initiatives and projects to reduce waste, cost and variation through use of Lean and Six Sigma tools and methodologies. He/she will utilize his/her knowledge of COGs, gross margin, facility design, material handling equipment, labor management, staff planning and project execution to identify, prioritize and recommend improvement projects and training modules that align with the Operational Excellence team charter and organizational goals and objectives.

Responsibilities:

  • Participates in identification and planning of department goals implementation of initiatives intended to improve quality, cost and delivery.
  • Serves as an engaging and collaborative teacher/trainer providing internal standardized lean training and consulting support for Lean & Six Sigma tools, data mining and presentation with heavy emphasis on MS Excel.
  • Supports productivity, quality, process efficiency, space utilization, standard updates and lead time improvement efforts for existing and new product development programs.
  • Supports the philosophy of waste reduction through implementation of Lean and Six Sigma approaches within the organization.
  • Utilizes tools and methodologies including, but not limited to: time studies, line balancing, setup time reductions, line layout creation, flow improvement, 5S, standard work, visual factory improvements and accountability systems.
  • Collaborates with cross-functional teams.
  • Evaluates, designs and implements new production line and facility layouts.
  • Leads and/or facilitates A3 projects and teams.
  • Collaborates with others on Key Process Indicator development and implementation.
  • Seeks out continuous improvement opportunities, weighs their value based on benefit, investment and risk, and prioritizes work, accordingly.
  • Participates in project work to help customers and operators achieve sustainable results.
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS degree in Industrial Engineering highly preferred.   Advanced degree a plus.
  • 2 to 5 years manufacturing experience, preferably in medical device and/or machining.
  • Strong MS Excel knowledge.
  • Six Sigma or Lean Certification (ASQ or IASSC) is a plus.
  • Strong analytical, problem solving and project management skills.
  • Be a learner; adaptable to accept new changes in the field of lean manufacturing and desire to remain knowledgeable with regard to the latest developments in field.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to influence and engage others to accomplish projects
  • Must be a clear communicator of ideas in both written and oral forms to all levels of the organization.
  • Strong organizational abilities; can multitask and prioritize to meet deadlines in timely manner.
  • Ability to travel to other sites (approximately 5-10%).

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None/PPE

WORKING ENVIRONMENT

Work is performed in both an office and manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Engineer

Summary:

This position is primarily responsible for Design Control (product development), Regulatory compliance, qualitative and quantitative data analysis, complaint investigation and analysis, Manufacturing support, Training, Metrology and Gage R&R, and other Quality functions.   Additionally, this role is expected to provide input and contribute on Quality System strategies and approach.

Responsibilities:

  • Develop and perform operational and process qualifications for customer manufacturing processes in conjunction with other engineering departments.
  • Assist with the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments.
  • Initiate the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments per project requirements.
  • Generate the Quality Plan for development projects.
  • Provide direction in implementing Incoming Inspection plan, First Article Inspection plans, In-Process and Final Product Inspection.
  • Create appropriate sampling plans along with identifying inspection and acceptance criteria.
  • Review and/or document Design Control activities for Project Phase Reviews and Product Verification testing as required per project requirements.
  • Perform vendor audits and qualifications.
  • Represent quality engineering in phase reviews and other aspects throughout product development.
  • Manage the internal audit system schedule and perform the duties of a Lead Auditor including    training internal auditors.
  • Perform internal audits to assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality System, including investigation observations and findings and reporting.
  • Member of customer and 3rd party quality audit team.  May be required to lead this effort.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NMR’s.
  • Provide trending analysis on CAPA, NMR and other quality metrics.
  • Provide quality oversight on maintaining ISO Class 7 clean rooms including review and trending of the testing and monitoring reports.
  • Strong verbal and written communication skills, including technical report writing.
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.
  • Demonstrated use of Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, and Gauge R&R.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • AS/BA/BS in Quality Engineering or related discipline.
  • Minimum experience in medical/manufacturing environment: 5 years (BS) OR 10 years (AS).
  • Extensive experience with medical device QSRs in design control and production environments.
  • Strong familiarity with Class II or Class III medical devices requirements.
  • Knowledge of FDA/cGMP and MDD regulations/guidelines.
  • Experienced with ISO13485.
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess excellent verbal communication, organizational and management skills.

Preferred Requirements:

  • CQE certification.
  • Strong verbal and written communication skills, including technical report writing.
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.
  • Demonstrated use of Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, and Gauge R&R.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Thin Film Process Development Engineer

Summary:

This position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients on projects of low to moderate complexity.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Have input to project manager for tracking and communicating project status, plans, issues, timelines, action items, and budgets.
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection, and technology identification in support of high-volume manufacturing of thin film devices
    • Process development of, metallization system using thin film deposition and plating methods
    • Development of photolithography and etching processes (wet and dry)
    • Process Failure Mode Effects Analysis
    • Prototype builds
    • Process Validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation
    • Materials sourcing and device prototyping
    • Design verification and validation activities, including data for regulatory submission
    • Manufacturing transfer and support of existing product lines as applicable
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Willingness to travel, if required.
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills.
  • Must be able to read, write and speak fluent English.
  • A Bachelor’s degree in an engineering discipline and minimum 4 years appropriate work experience; or Associate’s degree in engineering discipline and a minimum or 6 years appropriate work experience; or a minimum 10 years relevant work experience; or equivalent.
  • Experience in an engineering and cleanroom manufacturing environment with a focus on mechanical, photolithography, wet and dry etching manufacturing processes.
  • Experience with thin film metallization deposition equipment and customer process development.
  • Experience with manual and automatic photolithography equipment and development of custom processes.
  • Experience developing wet and dry etching processes.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
  • Ability to learn and apply new technology.
  • Technical report preparation and formal presentation skills.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Equipment Maintenance Technician

Summary:

This position is primarily responsible for all preventative and corrective maintenance on equipment located in the fab and plating areas.  Maximum emphasis is placed on positive response to the concerns and needs of the company and its environmental health and safety. This is a hands-on position that the equipment maintenance technician works independently and is capable of being successful in a matrix organization.

Responsibilities:

  • Responsible for preventative and corrective maintenance on all fab / plating area tool sets, including component disassembly / assembly / repair.
  • Responsible for identifying needed parts for repairs / preventative maintenance.
  • Properly hand and store chemicals and hazardous waste..
  • Maintain written logs of maintenance and repairs in our online system.
  • Ensure that facility maintenance requirements are consistently met.
  • Promptly respond to facilities related issues and ensure effective resolution.
  • Keep apprised of current regulations in order to effectively address and ensure compliance with ADA (Americans with Disabilities Act), OSHA (Occupational Safety & Health Administration), fire codes requirements, and Material Management for Hazardous Material.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • Minimum 4 years’ experience in performing preventative and corrective maintenance on semiconductor related equipment.  Similar equipment experience will be considered.
  • Able to troubleshoot electronic circuits to a component level.
  • Familiar with vacuum systems.
  • Must have good computer, written and oral skills.
  • Manual dexterity and visual acuity are required to perform responsibilities.
  • Must be able to lift 60 lbs.
  • Must be willing to work some weekends, alternating coverage with other maintenance techs.
  • Must be legally authorized to work in the United States.
  • Extensive experience with supplier negotiations and supplier management.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 60 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

General Referral Application

General Referral

Don’t see a position that fits your background and experience? We are always accepting applications and resumes that we keep on file. If we open a new position that better fits your background and experience we can review your general referral application.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com