Careers with Cirtec – Medical Device Design, Development and Manufacturing

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

Calibration Technician

Summary:

The calibration technician will inspect, test, maintain and repair a variety of electronic and mechanical equipment to ensure measurement accuracy. The calibration technician will also review customer requirements to ensure proper gaging is procured prior to manufacturing produces the parts.

Responsibilities:

  • Establishes and maintains a calibration system to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results
  • Establishes and maintains a calibration system to ensure that equipment is routinely calibrated, inspected, checked, and maintained. Ensure there are provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained
  • Ensures the calibration system is well documented to ensure equipment is calibrated on a routine schedule and are traceable to national standards when applicable
  • Coordinates calibration onsite service calls
  • Assists the quality department in developing and maintaining the ISO procedures and work instructions
  • Adheres to Cirtec operational procedures to maintain ISO and FDA compliance
  • Ensures effective gage planning and procurement while being aware of cost impact and maintaining budget spending
  • Ensures that control of nonconforming product is identified, documented, evaluated, segregated, and disposition has been determined
  • Calibration of all measuring devices being conducted on time (0% past-due)
    • Maintains the calibration system and ensures no equipment is used beyond the recommended calibration period
    • Ensures all equipment is marked stating the status of calibration. If calibration is not required, the equipment will maintain a sticker stating reference only.
  • Creates Gage kits for Manufacturing Teams within two days
    • Works with Engineering and Manufacturing teams to create Gage Kits for long running manufacturing jobs within two days of request
  • Ensures gages are procured and received prior to start of production
    • Reviews released jobs and ensures gaging is ordered and received prior to start of production
  • Decreases the cost of Calibration
    • Continually looks at ways to save money
    • Requests quotes for procured equipment
    • Schedules multiple on-site calibration at same time to reduce cost
  • Develops time saving Inspection Methods
    • Enhances capabilities, by leveraging automation, fixturing, etc., and be more efficient with inspections, while still maintaining a high level of quality
  • Trains and coaches employees on all inspection, measuring, and test equipment and other courses as they are created
  • Communicates the quality status of all styles to leadership team
  • Provides quality leadership and expertise to teams
  • Actively promotes an environment that focuses on customer quality, continuous improvement and teamwork
  • Represents QA on project teams
  • Participates in internal, regulatory, and supplier quality audits
  • Participates in Material Review Board (MRB), as needed
  • Other tasks as assigned

Requirements:

  • Self-starter, ability to handle multiple priorities, and detail oriented
  • A solid understanding of blueprint reading, geometric dimensioning and tolerances, statistical process control, visual inspection tools, and mechanical measuring tools
  • Solid troubleshooting, root-cause, and continuous improvement skills
  • Excellent written and verbal communication
  • Working knowledge of Microsoft Office
  • BS, High school diploma, or GED
  • Five years of related experience
APPLY NOW  – or email Careers@Cirtecmed.com

Development Test Technician

Summary:

The Development Test Technician provides technical quality engineering support on product development teams for R&D efforts; primarily focused on developing, validating and executing test methods and verification/validation testing of medical devices.

Responsibilities:

  • Executes documented test methods and provide summary data.
  • Confidently converts customer and engineering requirements into test methodologies with limited supervision.
  • Conducts measurement system analysis, including Gage R&R, to assess equipment and test methods.
  • Maintains calibration schedule for tools and equipment per the corporate Quality System.
  • Provides initial training of new test methods to appropriate designees.
  • Drafts and executes installation and tooling qualifications on simple fixtures and/or equipment.
  • Development of new equipment and fixturing to support test methods.
  • Interacts effectively and assists engineering in improving quality and solve problems.
  • Works with engineering or designers to design fixtures for procedures developed.
  • Incorporates FDA guidance and international standards into functional test methods and their validations
  • Development of new equipment and fixturing to support test methods.
  • Implementation of standardized test methods into robust test method, test protocol, and test report templates
  • Understands and integrates clinical relevance/risk when appropriate.
  • Incorporates user needs into test method development (i.e., ergonomic impact, lab efficiency, etc.)
  • Understands appropriate statistical methods to analyze Test Method Validation data and present results
  • Shows self-motivation to optimize job performance on a continual basis.
  • Maintains a clean and orderly work area.
  • Ability to diagnose and solve problems with jobs in a timely manner.

Requirements:

  • 3-5 years of experience in research and development and/or design assurance testing
  • Experience in the Medical Device industry
  • Established experience with: Design Controls, Design Review, Design Verification and Validation, Test Method development and validation, DOE, Statistics including  ANOVA, Characterization, Validation
  • Able to manage work load across multiple tasks
  • Self-directed
APPLY NOW  – or email Careers@Cirtecmed.com

Tool Design Engineer

Summary:

Provide support to engineering, production, and quality while adhering to quality system requirements. This position is responsible for developing and improving tooling and fixtures from concepts and sketches into drafting prints while complying with industry drafting standards. Activities completed in this position must be implemented in accordance with Good Manufacturing Practices, Good Documentation Practices, ISO and FDA requirements.

Responsibilities:

  • Generates 3D models and Engineering drawings
  • Creates detailed tooling, gage, and fixture engineering drawings independently and with input from the subject matter expert or engineer
  • Reviews engineering drawings to ensure adherence to specifications and standards
  • Performs dimensional stack-ups, making adjustments as needed for best-fits
  • Manages workload to support various departments
  • Reviews external customer CAD files for drawing requirements and modifies as needed to support internal customers
  • Initiates and or reviews ECO’s for Drawing releases and revisions
  • Works effectively with other departments to resolve drawing discrepancies
  • Works with product development teams to ensure compliance when transferring documents to production releases
  • Maintains strict adherence for multiple CAD file relationships, models, assemblies, libraries and symbols
  • Maintains compliance to procedures and regulatory requirements
  • Understands and follows safety policies and practices, attend safety training and wear PPE as required
  • Other duties as assigned

Requirements:

  • FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
  • 3 plus years’ experience in the engineering/manufacturing environment (Machining, Finishing, and assembly) for medical devices related to drafting and tool design
  • Proficiency with Solidworks required with Pro-E/CREO experience
  • Solid working knowledge of dimensioning and Geometric tolerances, GD&T
  • Blueprint reading
  • Computer skills associated with Microsoft software
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Maintains performance with changing priorities under minimal supervision
  • Possess team collaboration skills
  • Must be able to make clear and accurate decisions
  • Strong mechanical aptitude
  • PDM file management experience preferred
  • Associates degree in an Engineering discipline or related field
APPLY NOW  – or email Careers@Cirtecmed.com

Customer Service Manager

Summary:

Supervise Customer Service department personnel while assisting Engineering and Sales in the functions of their department.  This position will be responsible for reporting the on-time delivery metric and providing this information to senior management. Must be able to perform diverse, complex, analytical administrative duties and requires strong organizational and communication skills to the Engineering and Sales Departments.   This position will interface with key customers and sales representatives as related to incoming orders, RFQ’s, purchase order related requests/concerns.   Manage a wide variety of confidential assignments and situations.

Responsibilities:

  • Assists engineers in developing and maintaining project documentation
  • Organizes large amounts of information into a meaningful, systematic format
  • Maintains the integrity of the documentation database as it pertains to Engineering, Sales and Quality
  • Prioritizes a variety of tasks with little or no supervision to meet deadlines
  • Manages, maintains and analyzes engineering documents
  • Coordinates changes to engineering documents and quality records through the ECO system including distribution/retrieval, obsolescence, verification of compliance with policies and procedures and manufacturing database information entry
  • Custodian of electronic files within the Made2Manage system as it pertains to Engineering
  • Monitors, distributes and maintains quotes and leads as they pertain to sales reps and provide monthly reports to leadership team

Requirements:

  • Must have strong professional presentation and interpersonal skills over the phone and in person
  • Possesses an advanced level of computer skills with MS Office Suite (Excel, Word, Access, and Outlook).  This includes the ability to apply advanced formatting to MS Word documents, to build Excel spreadsheets and to create forms and reports
  • 5 years of experience in a professional office environment, which required interaction with internal and external customers
  • Read, write and communicate using English language sufficient to perform job function
  • BS Degree in Business Administration/Management (preferred)
  • A minimum 10 years of Customer Service experience (Customer Service Management preferred)
  • Leadership and Supervisory training (desired)
  • Ability to solve practical and complex problems
  • Ability to manage a variety of instructions furnished in written, oral, diagram or schedule form
  • Knowledge of documentation procedures and ISO
  • Ability to interpret blueprints and engineering specifications
APPLY NOW  – or email Careers@Cirtecmed.com

Quality Inspector - 2nd or 3rd Shift

Summary:

The Quality Inspector ensures that all Cirtec products meet requirements for both visual and mechanical inspections as required based on print and inspection plans. Strict workmanship standards have been established and are taught to each employee.

Responsibilities:

  • Must demonstrate ability to perform visual inspections with microscopes at specified magnification and with a Visual Measuring System
  • Must be able to use Visual Measuring System and develop required statistical data
  • Ability to decipher blueprints and inspection plans to fully understand customer quality requirements
  • Attain knowledge of all Cirtec’s procedures, work instruction and forms related to your job process
  • Maintain a clean and orderly work area on a consistent basis
  • Communicate the quality status of all styles to the Inspection Lead
  • Read and follow Cirtec’s handbook and maintain an attendance and tardiness record within the set limits of company policy
  • Other tasks as assigned

Requirements:

  • Must have a minimum of two years final inspection experience
  • Self-starter, ability to handle multiple priorities, and detail oriented
  • A solid understanding of blueprint reading, geometric dimensioning and tolerances, statistical process control, visual inspection tools, and mechanical measuring tools
  • Excellent written and verbal communication
  • BS/BA/BE, AA, or applicable experience
APPLY NOW – or email Careers@Cirtecmed.com

Sales Operations Coordinator - Can be based in MN or CT

Summary:

The Sales Operations Coordinator has the primary responsibility for both the review and analysis of new and existing business opportunities. This includes, but is not limited to the development, tracking and communicating of quoting activities for both the Enfield, CT and Brooklyn Park, MN sites. The Sales Operations Coordinator will own the quoting process and deliver finished proposals within targeted timeframes. They will ensure Cirtec’s services are quoted accurately for device design, development, and manufacturing activities. They will create cost models and pricing strategies, and effectively communicate these metrics internally and externally.

Responsibilities:

  • Establishes the cost price on the basis of purchased components, labor, and other engineering and operational metrics for all Cirtec locations
  • Develops value-added propositions and written proposals
  • Evaluates, develops, and implements alternative manufacturing methods, sources of supply, and engineering strategies
  • Suggests a pricing strategy in coordination with Sales colleagues on the basis of the cost of goods and organizational objectives
  • Provides timely, accurate quotes for delivery to Sales and Project Managers on new or revised programs
  • Follows the quote during the steps of negotiations with the customer until the acquisition of the order (quote revisions, technical review, scope changes) in collaboration with the Sales and Program Management teams
  • Takes part in kick-off meetings, forwards and explains to colleagues in charge of the project, the elements of the proposal (technical, budget, timelines, milestones, limits of supplies, and delivery)
  • Works directly with customers to understand their processes and develop the best solutions for their requirements. Occasional travel may be required
  • Provides input for corporate budgets and capital equipment acquisition
  • Communicates with cross functional personnel and executive management with equal effectiveness and professionalism

Requirements/Qualifications:

  • 4 year degree in an Engineering field, plus 5 years manufacturing engineering work experience or Master’s degree, plus 3 years manufacturing engineering work experience
  • Program or product management in a regulated industry is a plus
  • Team leadership and direct customer engagement experience
  • Medical device experience required (knowledge of implantable medical device product development, manufacturing, and cost of goods is preferred)
  • Knowledge and experience related to sourcing and quoting device assemblies
  • Excellent financial, organizational, writing and verbal skills are a must
  • Strong customer-centric mindset
  • Ability to organize many details and manage multiple priorities related to customer requirements, and organizational financial objectives
  • Strategic problem solving
  • Occasional travel (25%)
APPLY NOW – or email Careers@Cirtecmed.com

Press Room Setup / Operator

Summary:

Responsible for setting up, debugging, and operating limited types of the equipment in the Press Room, which may require supervision, ensuring quality product is manufactured in accordance with company and ISO procedures.

Responsibilities:

  • Performs a variety of moderate stamping, drawing and forming operations, which includes the use of compound, combination and some progressive dies
  • Setup a variety of different tools from simple to complex with supervision
  • Runs all types of equipment safely and smoothly, reports when rates aren’t achievable and may be part of implementing changes in order to achieve quoted rates
  • Promptly watches, listens and recognizes any changes or faulty operations in any process that they have been trained on
  • Responsible for the quality of the parts they produce and following manufacturing inspection plans
  • Records statistical process controls and runs any type of inspection equipment they have been trained on
  • Able to load coils
  • Follows detailed work instructions, both verbal and written (traveler and any other)
  • Packages parts
  • Maintains a clean, organized and safe work environment
  • Performs machine maintenance, preventative maintenance and safety checks as required
  • Reads blue prints and understands basic geometric tolerances
  • Pro-actively pursues continuing education and personal development opportunities in area of expertise
  • Follows all company and ISO procedures, maintains procedures as assigned and 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

Requirements:

  • High school diploma or equivalent
  • 1 to 3 years minimum experience setting up and operating automatic mechanical punch presses and various other types of equipment
  • Background in producing complex parts with tight tolerances
  • Can read prints and follow inspection instructions or procedures
  • Knowledge of statistical process controls and can record measurements on parts being produced
  • Able to operate or be trained on all types of inspection equipment
  • Ability to work well with others
  • Ability to accept responsibility and account for his/her actions
  • Ability to take care of the customers’ needs while following company procedures
  • Ability to be truthful and be seen as credible in the workplace
  • Ability to participate in needed learning activities in a way that makes the most of the learning experience
  • Ability to use thinking and reasoning to solve a problem
  • Assess own strengths and weaknesses, pursue training and development opportunities, strive to continuously build knowledge and skills and share expertise with others
  • Identify and resolves problems in a timely manner, gather and analyze information skillfully, develop alternative solutions, works well in group problem solving situations and uses reason even when dealing with emotional topics
  • Ability to pay attention to the minute details of a project, task, or work instruction
APPLY NOW – or email Careers@Cirtecmed.com

CNC Milling Machinist

Summary:

To set up and maintain all set-ups on CNC machinery. To be self-motivated and ensure the product is done on time and of the highest quality possible. To have excellent trouble shooting ability on both the machine and tooling and to assist the supervisor and/or lead person as well as the programmers with the operation of the department.

Responsibilities:

  • Must accurately complete all department paperwork including job travelers, inspection documentation, and work packet information and tooling request forms
  • Must have a general understanding of Cirtec Medical workmanship standards
  • Must be able to maintain an acceptable efficiency operating machinery
  • Must have the ability to change most types of tooling used in various machines
  • Active participation in team meetings and improving quality programs
  • Must be familiar with functions of the machine including tool and work offsets and be able to adjust them to ensure quality components are being manufactured
  • Must demonstrate concern for equipment by proper use of all equipment and maintaining a clean work environment
  • Must demonstrate an ability to use inspection equipment as required, including vision systems
  • Must have the ability to solve problems to maintain quality and efficiency while working within the team
  • Must have a good attendance record
  • Must have the ability to pass internal blue print reading and workmanship tests
  • Must understand company policies and procedures
  • Must maintain a high level of quality
  • Excellent working knowledge of blueprints and geometric tolerance
  • Must interact effectively with engineering and quality individuals to solve problems that may arise in a professional and timely manner
  • Must have extensive knowledge of all phases of machining and equipment
  • Must demonstrate good decision making and problem solving
  • Continually train co-workers to encourage individual growth within the team and within the company
  • Must have the ability to set up and run all jobs within the department
  • Must promote good morale and productivity
  • Must have the ability to increase production and streamline set-ups for optimum efficiencies and quality
  • Must have the ability to trouble shoot quality problems by effectively utilizing process control and corrective actions
  • Must maintain a very high level of cleanliness and organization and promote this within the team

Requirements:

  • Ability to interpret tolerances, GD&T, dimensions, finish requirements, part views, etc. on engineering blue prints
  • Minimum of 3 years of experience with set-ups, operating and troubleshooting CNC vertical mills
  • Ability to operate vision systems and inspection equipment
APPLY NOW – or email Careers@Cirtecmed.com

In-Process Inspection/Deburring - 1st or 2nd Shift

Summary:

Deburrer needed to inspect parts for burrs, identify and remove burrs with speed and accuracy. To be a self-motivated individual with passion, integrity & commitment towards all work assignments. To produce the highest quality parts in the least amount of time.

Responsibilities:

  • Identifies all burrs on part & proficiently remove them with minimal errors
  • Demonstrates the ability to read blueprints
  • Safely uses knives and other deburring tools
  • Communicates effectively with team members
  • Maintains good attendance
  • Keeps a clean and orderly work area
  • Accurately records data on routers
  • Ability to use general shop math
  • Proficient use of a microscope at 20 power minimum

Requirements:

  • One year experience working under microscope (at 20 power minimum)
  • 6 months experience using knives and other deburring tools
APPLY NOW – or email Careers@Cirtecmed.com

Swiss Machinist Level-III/Shift Lead

Summary:

Motivate self and shift personnel to meet production and quality goals and objectives.  Provide complete, timely, and informative communication between other shift leads.  Ensure that Production Control schedule is followed and contribute to all teams reaching monthly sales and quality goals. Must understand the job requirements of the team manager and be able to maintain the department in their absence.

Responsibilities:

  • Accurately completes all department paperwork including job travelers, Inspection documentation, work packet information, and tooling request forms
  • Excellent working knowledge of blueprints and geometric tolerance
  • Must have extensive knowledge of all phases of machining and equipment
  • Must demonstrate good decision making and problem solving
  • Must have the ability to set up and run all jobs within the department
  • Must have the ability to increase production and streamline set-ups for optimum efficiencies and quality
  • Must have the ability to troubleshoot quality problems by effectively utilizing process control and corrective actions
  • Shift Lead may spend up to 70% of time on a machine and 30% in Lead platform when required
  • Must have exceptional communication skills and work well with people
  • Must provide leadership to the teams on all shifts and interrelate well with all areas of the company
  • Must effectively resolve all problems that arise or seek assistance in a timely manner
  • Must understand company policies and procedures and ensures the team follows them
  • Must assist in maintaining schedules of machines to best meet customer requirements
  • Must perform duties in a manner to promote good team and company morale
  • Must demonstrate responsibility for company efficiency, quality, pre-production planning, process control, corrective actions, cleanliness and safety, and continually strives for process improvements
  • Must continually mentor co-workers to encourage individual growth within company
  • Must develop a complete knowledge of management software as it pertains to the shop by supporting Production Control and tool crib. Printing routers, IP’s, and blue prints when needed
  • Emergency Coordinator for off shifts by initiating proper response to all kinds of emergency situations.  Handling employee safety and building needs
  • Responsible for all employee and building issues including security. Contacting Cirtec Management and / or Building services as needed
  • Responsible for recommending disciplinary action to Team Manager and handling  employee discipline in a professional manner as per company guidelines
  • Responsible for weekly and monthly platinum machine cleanout and control of platinum inventory
  • Responsible for assisting teams to achieve 100% monthly shipping goals, quality goals, and team goals

Shift Lead Authority:

  • Handles employee discipline in a professional manner as per company guidelines
  • Assists in all department functions
  • Assists programmers with new and better means of productivity
  • Responsible for all quality and productivity within the department
  • Responsible to meet or exceed team budgets and goals
  • Develops performance reviews and make recommendations

Requirements:

  • Minimum of 2 years supervisory experience
  • Minimum of 5 years’ experience with set ups and troubleshooting
  • Mechanical medical machining background a preferred
  • Team membership and leader training
  • Read ISO procedures that apply to this position
  • Strong blue print reading skills
  • Strong problem solving skills
APPLY NOW – or email Careers@Cirtecmed.com

Business Systems Manager - Can be based in MN or CT

Summary:

This individual is responsible for supporting sales and marketing by driving the sales quoting process. This includes detailed technical analysis and proposal writing to support RFQ and grants applications.  This individual will work closely with Business Development, Operations and Finance to develop quotes, product pricing models and assist in the construction of overall program timelines.  In addition, he or she will analyze sales opportunities and support the approval process.  Finally, this individual will be responsible for developing dashboards and other strategic sales reporting tools.

Outcome Required & Strategic Priorities:

  • Develop and implement quote process for new development and manufacturing opportunities
  • Develop quote metrics
  • Oversee all quoting activities, including existing manufacturing repricing to ensure financial objectives are being met

Main Responsibilities / Critical Tasks:

  • Coordinate all quoting activities for Cirtec’s Brooklyn Park and Enfield operations.
  • Develop quote metrics and report to management periodically
  • Meet with perspective customers to understand needs and develop quote based on inputs
  • Assist with sales pipeline management

Skills & Knowledge:

  • Technical Bachelor’s Degree, MBA preferred
  • Strong background in Class II and III medical devices (neuromodulation and cardiac assist knowledge a plus)
  • Strong industry involvement a plus
  • Program Management skills
  • Microsoft Project and general software skills required (Word, Excel, PowerPoint etc.)
  • Excellent communication skills both written and verbal
  • Strong financial background
  • CM Operational experience
  • Experience quoting design and development activities.
  • Experience building product cost models

Behavioral Competencies:

  • Multitasker
  • Self motivated
  • Ability to plan and organize in ambiguous situations.
  • Exceptional communication and problem solving skills
  • Strong analytic skills
  • Critical thinker
APPLY NOW – or email Careers@Cirtecmed.com

Swiss Machinist - Full Time, Monday - Thursday or Weekend Shift

Summary:

The primary purpose of this job is to set up, operate and maintain CNC equipment to fabricate production parts.

Hours & Shifts:

  • 1st shift is Monday – Thursday from 5:00 AM – 3:30 PM
  • 2nd shift is Monday – Thursday from 3:30 PM – 2:00 AM
  • Weekend shift is Friday – Sunday from 6:00 AM – 6:30 PM

Responsibilities:

  • Operates and sets up CNC shop equipment
  • Makes adjustments and monitors assigned equipment to ensure dimensional part integrity
  • Able to preset tooling for setups and tool breakages during normal operations
  • Maintains tooling following established tool life guide lines
  • Troubleshoots and corrects problem with minimal assistance
  • Inspects parts visually and dimensionally using basic inspection equipment and techniques to assure conformance to requirements with minimal assistance
  • Completes all applicable documentation for current operations
  • Performs preventative machine maintenance as required
  • Performs other functions as required

Requirements:

  • 2-5 years machine shop experience in all phases of machining
  • Ability to read, interpret and understand blueprints
  • Ability to work with small precision parts to very close tolerances
  • Ability to understand and follow through with verbal or written instructions
APPLY NOW – or email Careers@Cirtecmed.com

Opportunities in Enfield, CT

Sr. Continuous Improvement Engineer

Overview:

At Cirtec Medical, 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. Every employee is highly valued and crucial to our success. We place a high value on performance excellence, career development, safety, rewards and communication. 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. We are seeking an experienced Continuous Improvement Engineer to work closely with the cross functional Value Stream teams. This position will design, develop, standardize and implement Operational Excellence methods intended to continuously improve manufacturing system performance. This individual is an influencer and facilitator, with a track record of managing change. This individual is a systems thinker who solves problems by building relationships and collaborating.

Operational Excellence at Cirtec Medical

The Operational Excellence (OpEx) program at Cirtec Medical functions under the philosophy where problem-solving, teamwork, leadership and utilization of best practices are based on the Toyota Production System and result in ongoing performance improvement throughout the organization.  At its core, the Operational Excellence program seeks to minimize waste and variation through Lean and Six Sigma approaches respectively, leading to improved products, services, processes and systems that operate at high efficiency levels.

OpEx Mission – Our mission is to constantly improve the effectiveness of the Continuous Improvement system focused on reduction of waste and variation in all business segments and locations.

OpEx Vision – Our vision includes a culture that fully embraces and supports continuous improvement initiatives throughout the organization and a business that is continuously working to improve operational performance.

Job Summary:

The Continuous Improvement Engineer is a key member of the organization. The CI Engineer 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 projects to reduce waste 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 that align with the Operational Excellence team charter and organizational goals and objectives.

Responsibilities:

  • Participates in identification and planning of department goals and standardization and implementation of initiatives intended to improve quality, cost and delivery
  • Supports productivity, quality, process efficiency, space utilization, and standardization and lead time improvement efforts for existing and new product development programs
  • Supports the philosophy of the Toyota Production System through leading standardized use of Lean and Six Sigma approaches within the organization
  • Utilizes tools and methodologies including, value stream mapping, time studies, line balancing efforts, setup time reductions, process layout and flow improvement, 5S and standard work
  • Collaborates with cross functional teams as required
  • Evaluates, designs and implements new layouts: including storage rack, conveyor, automation, and other material handling solutions for facilities
  • Leads facility kaizen and productivity projects; ensuring projects are done according to budget and timeline
  • May supervise and provide work direction to other engineers and technicians
  • Serves as a statistical resource to a manufacturing/research facility requires a mastery of basic to advanced statistical techniques
  • Serves as an engaging and collaborative teacher providing internal consulting support for use in Lean & Six Sigma tools and data mining and presentation
  • Seeks out continuous improvement opportunities, weights their value based on benefit, investment and risk, and prioritizes work, accordingly
  • Participates in project work to help customers and operators achieve sustainable results

Requirements:

  • BS degree, preferably in Industrial Engineering or related field or equivalent experience; advanced degree a plus
  • 7 to 15 years in years manufacturing experience; preferably in medical device; preferably in machining and assembly of implantables
  • Six Sigma or Lean Certification (ASQ or IASSC) preferred
  • Strong analytical, problem solving and project management skills
  • Demonstrated leadership capability in team settings
  • Be adaptable to accept new changes in the field of lean manufacturing and should remain abreast with the latest developments happening in that 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; multitasks, prioritizes and meets deadlines in timely manner
  • Ability to travel to sister sites (approximately 5-10%)
APPLY NOW  – or email Careers@Cirtecmed.com

Program Manager

Summary:

The Program Manager is responsible for executing the project plan and managing the project initiative to established budget and timeline. Coordinate the design, development, documentation, schedules, and validation of moderately complex new and modified customer products.

Responsibilities:

  • Organizes a project plan for moderately complex projects to satisfy milestones and deadlines with required actions. Tracks and communicates project status, plans, issues, timelines, action items, and budgets internally and externally.
  • Serves as principal contact with clients.  Coordinates and directs site visits, conference calls, and day-to-day customer communication.
  • Coordinates development, validation and documentation of new products and expansion of existing products, including defining requirements, timelines, and deliverables. This may include engineering support of manufacturing operations for some products.
  • Proactively monitors the performance of assigned projects to budget and schedule to identify trends or project challenges that may impact budget and timeline. Recommends and implements corrective actions.
  • Oversees the process of preparing new or modified products ensuring compliance to internal and client requirements for project completion or testing and manufacturing transfer.
  • Authors planning documents as required to support assigned projects.
  • Contributes to quality, design, and development activities or act as backup to engineers on assigned projects as required.
  • Assists business development with definition of project scope, timeline, and budget to support preparation of proposals, quotations, and change orders for clients.
  • Manages resources assigned to the project team to meet project goals/milestones.  Works with management to ensure project has proper resources assigned.
  • Other duties as assigned.

Requirements:

  • Willingness to travel, if required.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.

Educational:

  • Must be able to read, write and speak fluent English.
  • A Bachelor’s degree in an engineering discipline with two years of relevant experience or equivalent.

Technical:

  • Experience in an engineering/manufacturing environment with mechanical, tool design and manufacturing processes preferred.
  • 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.

Training:

  • On the job training as required to meet job requirements.
  • Must remain current with trends and developments in the incumbent’s engineering specialty.

Performance:

  • Decision Making and Problem Solving:  Must be able to make clear and accurate decisions.
  • Analytical Problem Solving:  Must be able to use a systematic approach to solving problems.
  • Interaction:  Must be able to communicate well verbally and in writing and work well in a team environment.
  • Versatility:  Able to respond to changing priorities with minimum disruption.  Ability to meet deadlines and manage projects across many departments.  Ability to handle multiple projects and customers at any given time.
  • Initiative:  Must be able to function with minimum supervision.
  • Leadership:  Must be able to lead discussions, teams and meetings with customers and staff related to job role.

 APPLY NOW – or email Careers@Cirtecmed.com

General Manager

Summary:

The General Manager (GM) reports directly to the CEO.  The GM has significant outside facing responsibilities and should be known as a go-to person for medical device contract design, development, and manufacturing services.  The GM is responsible to ensure that the facility meets the commitments made to clients and makes amends for commitments missed and has overall responsibility for managing the revenue and cost elements for the assigned facility.  The GM is responsible for planning, delegating, coordinating, staffing, organizing, and decision making to meet the above two objectives.  This successful market-focused leader is a Corporate Officer and a member of the Leadership Team.

The GM provides leadership and vision to the organization by supporting the CEO with the development of long range and annual plans, and assisting with the evaluation and reporting of progress on plans as well as communicating strategic objectives to the facility.

Responsibilities:

  • Focuses resources to drive customer success and takes responsibility for commitments made to clients and makes amends for commitments missed.
  • Provides tactical direction for projects and client interactions to meet client objectives for client success.
  • Provides input to the budget process and manages revenue and cost elements to achieve profitability goals for the facility.
  • Assists business development to secure new opportunities.
  • Increases site management’s effectiveness by recruiting, selecting, orienting, training, coaching, counseling, and disciplining managers; assigning accountabilities; developing a climate for offering information and opinions.
  • Assists CEO in developing strategic plan by studying technological and financial opportunities; presenting assumptions; recommending objectives.  Plays a major role in communicating values, strategies, and objectives to facility.
  • Works effectively in a collaborative fashion with the CEO on all matters pertaining to ongoing operations in the facility and to long-term growth and objectives.
  • Maintains quality services and products by enforcing and improving organization and quality standards. Collaborates with corporate staff to provide continuous improvements to policies and procedures.
  • Builds company image by collaborating with customers, government, community organizations, and employees.
  • Provides an effective voice for the company in the target community focusing on building relationships with current and potential clients, collaborators, industry organization, and technological community.
  • Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
  • Contributes to team effort by accomplishing related results as needed.
  • Other duties as assigned.

Requirements:

Educational:

  • Must be able to read, write and speak fluent English.
  • A Bachelors degree in an engineering discipline or equivalent.

Technical:

  • Minimum 5 years successful direct engineering management experience in the development of products from early stage development through production.
  • Minimum 5 years medical device industry experience.
  • Minimum 10 years experience in a multidisciplinary engineering and manufacturing environment with thorough knowledge of early stage development through manufacturing and continuous improvement.
  • Senior executive experience, proven organizational leadership ability and accountability for overseeing and managing a team, working cross-functionally, and delivering projects on schedule and within budget.
  • Strong collaboration, mentoring, team building, and development skills.
  • Knowledge of:
    • Product development tools and procedures.
    • FDA and ISO regulations for design control and manufacture of medical devices.
    • Project management tools and methodologies
  • Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations.
  • Ability to write reports, specifications, business correspondence and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
  • Evidence of outstanding personal values.

Training:

  • In house on the job training as required to meet job requirements.
  • Will attend technical classes and seminars as required to enhance job performance.

Performance:

  • Decision Making and Problem Solving:  Must be able to make clear & accurate decisions.
  • Analytical Problem Solving:  Must be able to use a systematic approach to solving problems by researching and evaluating alternative solutions.
  • Interaction:  Must be able to communicate well verbally and in writing and work well in a team environment.
  • Versatility:  Able to respond to changing priorities with minimum disruption.
  • Initiative:  Must be able to function with minimum supervision.
  • Leadership:  Must be able to lead teams and meetings with customers and staff related to job role.

 APPLY NOW – or email Careers@Cirtecmed.com

Business Systems Manager - Can be based in CT or MN

Summary:

This individual is responsible for supporting sales and marketing by driving the sales quoting process. This includes detailed technical analysis and proposal writing to support RFQ and grants applications.  This individual will work closely with Business Development, Operations and Finance to develop quotes, product pricing models and assist in the construction of overall program timelines.  In addition, he or she will analyze sales opportunities and support the approval process.  Finally, this individual will be responsible for developing dashboards and other strategic sales reporting tools.

Outcome Required & Strategic Priorities:

  • Develop and implement quote process for new development and manufacturing opportunities
  • Develop quote metrics
  • Oversee all quoting activities, including existing manufacturing repricing to ensure financial objectives are being met

Main Responsibilities / Critical Tasks:

  • Coordinate all quoting activities for Cirtec’s Brooklyn Park and Enfield operations.
  • Develop quote metrics and report to management periodically
  • Meet with perspective customers to understand needs and develop quote based on inputs
  • Assist with sales pipeline management

Skills & Knowledge:

  • Technical Bachelor’s Degree, MBA preferred
  • Strong background in Class II and III medical devices (neuromodulation and cardiac assist knowledge a plus)
  • Strong industry involvement a plus
  • Program Management skills
  • Microsoft Project and general software skills required (Word, Excel, PowerPoint etc.)
  • Excellent communication skills both written and verbal
  • Strong financial background
  • CM Operational experience
  • Experience quoting design and development activities.
  • Experience building product cost models

Behavioral Competencies:

  • Multitasker
  • Self motivated
  • Ability to plan and organize in ambiguous situations.
  • Exceptional communication and problem solving skills
  • Strong analytic skills
  • Critical thinker
APPLY NOW – or email Careers@Cirtecmed.com

Sr. Manufacturing Engineer

Summary:

The Senior Manufacturing Engineering position develops and implements 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.
  • Improves 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.
  • Develops, tests and cost justifies various tools and equipment recommended for manufacturing methods.
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
  • Utilizes tools associated with risk management (PFMEA/Hazard Analysis) to identify potential risks and the associated corrective actions.
  • Supports required equipment qualification/process validation.
  • Troubleshoots processes when defects occur. Determine root cause and implement effective containment and countermeasures.
  • Dispositions non-conforming products and develop re-work procedures.
  • Communicates with customers regarding process improvements and production changes.
  • Represents manufacturing on cross functional teams.
  • Participates in Kaizens and drive improvement efforts.

Requirements:

Educational:

  • Bachelor’s degree in Engineering or related field required.
  • Advanced knowledge of manufacturing and assembly processes.
  • A minimum of 5-8 years of engineering experience in a Medical manufacturing environment.
  • Previous experience and the ability to direct, lead and mentor engineers with respect to company engineering procedures, new product introduction, manufacturing support and tooling.
  • Excellent verbal and written communication skills.
  • Fluency in English.

Technical:

  • Previous experience with Class III Medical devices, FDA standards, ISO 13485 and GMP principles preferred.
  • Technical leadership experience managing engineering teams, budgets and resources throughout various design phases, development and implementation of a new products.
  • Experience working cross functionally with other disciplines including engineering, quality, planning and scheduling.
  • Ability to lead, train, and engage manufacturing team members to reach Cirtec’s quality standards.
  • 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.
  • A practical and logical approach to problem solving using lean six sigma concepts.
  • Interpersonal, presentation and communication skills.
  • Team working and people management 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.
  • An awareness of health and safety issues.
  • Willingness to travel, if required.

Training:

  • In house on the job training as required to meet job requirements.
  • Keep up with current industry technologies by attending training courses and conferences.

Performance:

  • Decision Making and Problem Solving: Must be able to make clear and accurate decisions.
  • Analytical Problem Solving: Must be able to use a systematic approach to solving problems by researching and evaluating alternative solutions.
  • Interaction: Must be able to communicate well, both verbally and in writing, and work well in a team environment.
  • Initiative: Able to function with minimum supervision
  • Versatility: Able to respond to changing priorities with minimum disruption.
  • Leadership: Must be able to lead discussions and meetings with customers and staff related to job role.

 APPLY NOW – or email Careers@Cirtecmed.com

Engineering Manager

Summary:

The Engineering Manager will provide functional supervision to the engineering department, consisting of research and development engineers and technicians, and mechanical designers.  The Engineering Manager will serve as Project Manager and/or technical lead for projects including validation and documentation of new product services, and expansion of existing product services including defining requirements, timelines, and deliverables.

Responsibilities:

  • Provides support & supervision to direct reports for the timely completion of projects, initiatives and key activities.
  • Mentors associates and fosters a learning and growth environment.  Performs evaluations at regular intervals.
  • Serves as secondary contact with clients; instilling confidence in our technical capabilities and quality products.
  • Ensures team is performing under the Cirtec quality system and with good engineering practices.
  • Ensures R&D, design and tooling resources are meeting project needs in both availability and talent in a multi-project environment.
  • Ensures that projects stay on schedule and are fully documented as required by medical device regulatory agencies.
  • Oversees the process of developing new or modified products ensuring compliance to internal, regulatory, and customer requirements.
  • Provides leadership for teams that will execute projects in all aspects of the development process to include: requirement and specification definition, risk management, design development, process development, sourcing and supply chain, prototype builds, device verification testing, process qualification, and transfer into manufacturing.
  • Manages day-to-day oversight of engineering support of the manufacturing operation for assigned customers after product release as necessary.
  • Assists with preparation of proposals and quotations for clients; interfaces as needed to resolve questions in a timely manner.
  • Other duties as assigned.

Requirements:

  • Ability to meet deadlines and manage projects across many departments.
  • Ability to handle multiple projects and customers 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 maintain high ethical standards
  • Must demonstrate good organizational skills.
  • Ability to train new engineering employees on Cirtec policies and procedures.

Educational:

  • Must be able to read, write and speak fluent English.
  • A Bachelors degree in an engineering discipline or equivalent.

Technical:

  • Demonstrated ability to lead engineering teams successfully from early stage development to production.
  • Minimum 7 years’ experience in an engineering/manufacturing environment.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications and illustrations.
  • Technical report preparation and formal presentation skills.
  • Strong analytical skills, must be able to obtain and evaluate secondary research information.
  • Ability to learn and apply new technology.
  • Exceptional knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.

 APPLY NOW – or email Careers@Cirtecmed.com

Quality Control Inspector-2nd shift

Summary:

Perform 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 nonconforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records and equipment calibration.

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

Requirements:

Educational:

  • Be able to read, write and speak fluent English
  • High school diploma
  • Minimum three years’ experience in manufacturing, preferably medical devices, with increasing responsibility or a minimum of five years’ experience in a manufacturing environment

Technical:

  • Certificate(s) of training related to this field of work (medical or quality assurance)
  • A minimum of three 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

Competencies:

  • Decision Making and Problem Solving: Able to take action in solving problems while exhibiting judgment and a realistic understanding of issues; able to make rational and justifiable technical decisions; does not jump to conclusions inappropriately
  • Policies and Procedures: Able to conform to all established policies and procedures, log/document work activities
  • Interaction: Able to communicate well verbally and in writing and work well in a team environment
  • Analytical Problem Solving: Able to use a systematic approach in solving problems through analysis of problem and evaluation of alternative solutions
  • Interaction: Able to clearly present information through the spoken work; influence or persuade others through oral presentation in the positive or negative circumstances; listen well
  • Versatility: Able to respond to changing priorities and requirements with minimum disruption
  • Initiative: Able to function with minimum supervision
  • Leadership: Able to lead discussions or meetings related to job role and provide leadership for production personnel on quality issues
APPLY NOW – or email Careers@Cirtecmed.com

Sales Operations Coordinator - Can be based in CT or MN

Summary:

The Sales Operations Coordinator has the primary responsibility for both the review and analysis of new and existing business opportunities. This includes, but is not limited to the development, tracking and communicating of quoting activities for both the Enfield, CT and Brooklyn Park, MN sites. The Sales Operations Coordinator will own the quoting process and deliver finished proposals within targeted timeframes. They will ensure Cirtec’s services are quoted accurately for device design, development, and manufacturing activities. They will create cost models and pricing strategies, and effectively communicate these metrics internally and externally.

Responsibilities:

  • Establishes the cost price on the basis of purchased components, labor, and other engineering and operational metrics for all Cirtec locations
  • Develops value-added propositions and written proposals
  • Evaluates, develops, and implements alternative manufacturing methods, sources of supply, and engineering strategies
  • Suggests a pricing strategy in coordination with Sales colleagues on the basis of the cost of goods and organizational objectives
  • Provides timely, accurate quotes for delivery to Sales and Project Managers on new or revised programs
  • Follows the quote during the steps of negotiations with the customer until the acquisition of the order (quote revisions, technical review, scope changes) in collaboration with the Sales and Program Management teams
  • Takes part in kick-off meetings, forwards and explains to colleagues in charge of the project, the elements of the proposal (technical, budget, timelines, milestones, limits of supplies, and delivery)
  • Works directly with customers to understand their processes and develop the best solutions for their requirements. Occasional travel may be required
  • Provides input for corporate budgets and capital equipment acquisition
  • Communicates with cross functional personnel and executive management with equal effectiveness and professionalism

Requirements/Qualifications:

  • 4 year degree in an Engineering field, plus 5 years manufacturing engineering work experience or Master’s degree, plus 3 years manufacturing engineering work experience
  • Program or product management in a regulated industry is a plus
  • Team leadership and direct customer engagement experience
  • Medical device experience required (knowledge of implantable medical device product development, manufacturing, and cost of goods is preferred)
  • Knowledge and experience related to sourcing and quoting device assemblies
  • Excellent financial, organizational, writing and verbal skills are a must
  • Strong customer-centric mindset
  • Ability to organize many details and manage multiple priorities related to customer requirements, and organizational financial objectives
  • Strategic problem solving
  • Occasional travel (25%)
APPLY NOW – or email Careers@Cirtecmed.com

Laser Technician - Levels I-IV - 2nd Shift

Summary:

The Laser Technician has the general responsibility for operating laser and associated systems used in the manufacturing of products sold to our customers. The Technician III is expected to work with and assist in the training of lower level technicians to effectively meet or exceed expectations for product quality and production rates. It is also expected that in this position the Technician III will continue to build their skills with the upper level Technicians along with taking tasks and direction from the Engineering departments. In this position you must proficient in setting up and operating workstations perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Has the primary skills of operating manufacturing workstations including all laser systems used in the manufacture of products sold to our customers. (Unitech, Triumpf, Lasag, IPG)
  • Perform laser welding, resistance welding laser marking, header pouring, silicone molding
  • Glovebox laser welding
  • Strong soldering experience. IPC 610 certification preferred
  • Demonstrates strict adherence to all safety, GMP & quality system guidelines
  • Proficient in the operation of computerized motion controllers
  • Proficient, at an intermediate level, in modifying or creating computerized motion control programs
  • Possesses the ability to accurately follow operating manuals, maintenance instructions, Standard operating procedures & work instructions
  • Working knowledge of drawings with an intermediate ability to interpret nomenclature and dimensions
  • Must accurately document all work performed on inspection reports and travelers
  • Performs in-process inspection of all parts and/or assemblies in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions
  • Performs various dimensional inspection using specific dies or gauges, or dimensional inspection systems, verniers and micrometers.
  • Provides direction within the manufacturing cell to Tech I or II associates assigned to assist them
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities
  • Assist facilities departments and upper level Technicians in duties such as flash lamp or filter changes on lasers
  • Ability to perform workstation set up requirements for any type of processing job using existing tooling and established parameters
  • Performs additional duties as required under the direction of the Production Team Leader or upper level Technicians
  • Responsible for recognizing quality issues and communicating issues to the Qulaity and/ or Production Supervision
  • Assists in ensuring the accuracy of Process Control Documents, Parameter Sheets, Work Instructions, and Standard Operating Procedures
  • Acts as a resource during audits or customer visits for questions and answers or practical demonstrations
  • Assist Upper level Technicians or Engineers with parameter adjustments and weld parameter/process development.
  • Ability to perform metallurgy (cross sections)
  • Performs weld validations and collects data for validation reports
  • Ability to provide input to Engineering and upper level Technicians in regards to tool design and/or troubleshooting processes
  • Performs other job duties as assigned with little or no assistance or supervision

Requirements:

Experience & Education:

  • Be able to read, write and speak fluent English
  • High school diploma or General Education Degree (GED) is required
  • Two to three years experience in a med device field preferred
  • One year applications experience or equivalent training

Technical:

  • Strong experience with a variety of laser welding equipment and techniques
  • Strong soldering skills (IPC 610 certification preferred)
  • Header pouring, laser marking, silicone molding, glove box laser welding
  • Moderate computer skills, including the MS Office suite
  • Must be able to interpret technical drawings, blueprints, specifications & illustrations
  • Strong analytical skills and must have the ability to obtain secondary research information from the Internet or alternate sources
  • Ability to learn and apply new technology
  • Technical report preparation

Physical:

  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds
APPLY NOW – or email Careers@Cirtecmed.com

Technician II - 2nd Shift

Summary:

A Technician II has the general responsibility for operating workstations and associated systems used in the manufacturing of products sold to our customers. The Technician II is expected to work with lower level Technicians and other upper level Technicians to effectively meet or exceed expectations for product quality and production rates. In this position they must have a basic knowledge of how to set up and operate workstations, perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Has the primary function of operating workstations used in the manufacturing processes
  • Proficient in set-up and loading component materials into product specific tools
  • Has the responsibility of following established documentation for product manufacturing
  • Demonstrates strict adherence to all safety, GMP & quality system guidelines
  • Must accurately document all work performed on inspection reports and customer travelers
  • Must have a general understanding of the CNC controlled workstations on the production floor
  • Possesses the ability to read and follow process control documents, work instructions, and standard operating procedures
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions
  • 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 various dimensional inspection using specific dies or gauges, or dimensional inspection systems, verniers and micrometers
  • Provides direction within the manufacturing cell to Tech I associates assigned to assist them
  • Ability to perform basic workstation set up and troubleshooting tasks
  • Performs additional duties as required under the direction of the Production Manager
  • Maintains cleanliness of work areas, machines, tools and equipment
  • Assists Quality Control with inspection duties as required
  • Responsible for recognizing quality issues and communicating these issues to quality and/ or Production Supervision
  • Performs other job duties as assigned with minimal supervision
APPLY NOW – or email Careers@Cirtecmed.com

Opportunities in Los Gatos, CA

Engineering Intern

Summary:

The Engineering Intern will assist in defining and developing products and processes in both the development and manufacturing environment.

Responsibilities:

  • Reviews and updates HW requirements, creates lab test procedures, collects test data, analyzes results and drafts engineering reports
  • Supports software and hardware testing and troubleshooting of electrical circuits using standard benchtop equipment in the laboratory
  • Assembles, prototypes, re-works and debugs electronic assemblies and PCBs
  • Performs other R&D and engineering related tasks as assigned

Requirements:

  • Must be a full-time student (Junior or Senior) pursuing a degree in Electrical, Computer Science or Biomedical Engineering with an emphasis in Electrical Engineering
  • Must have a 3.5 cumulative overall GPA or better (on a 4.0 scale)
  • Must have good fundamental understanding of analog and digital circuits
  • Adequate knowledge of reading schematics and data sheets for components
  • Software programming knowledge a plus
  • Good communication skills and ability to articulate technical problems
  • Strong Initiative and ability to work independently and in cross-functional teams
  • Legal authorization to work in the U.S.
APPLY NOW – or email Careers@Cirtecmed.com

Quality Assurance Specialist

Summary:

The QA Specialist shall review and have the authority to approve quality documents related to Incoming Inspection, Production, and Final Inspection. Ensures components and product meets company specifications and customer requirements.

Works with Operations and Engineering to continuously improve the quality of processes, components, assemblies and final product.

Responsibilities:

  • Ability to initiate Non-Conforming Material Reports (NCMR) and determine impact of non-conformances. Provides technical input for determining final disposition.
  • Oversees calibration and PM database system; maintains detailed and accurate records and initiates recall list for all calibrations/PMs performed internally and externally. Reviews calibration certificates for accuracy.  Determines product impact analysis for out of tolerance equipment.
  • Assists with corrective action and process investigations and implementation activities.  Oversees CAPA meeting and log.
  • Performs line audits of manufacturing process ensuring product and processes are in compliance per Quality Systems requirements.
  • Assists in preparing periodic quality metric reports for throughput, part acceptance performance for QA areas.
  • Assists in all activities relevant for customer and regulatory audits.
  • Ability to assist incoming, in-process and final inspection on a wide variety of parts and products. Other QA tasks as assigned.

Requirements:

  • Excellent verbal and writing skills using the English language
  • A good understanding of Microsoft Office and Excel
  • Ability to write accurate detailed inspection reports
  • Must be able to use a systematic approach to solve problems
  • Must be able to work in a team environment
  • Ability to interface and communicate with other groups effectively
  • Able to function with minimum supervision
  • Able to respond to changing priorities with minimum disruption

Educational:

  • Associates degree or equivalent is desired but not required
  • Minimum of 4 years of experience in the medical device industry
APPLY NOW – or email Careers@Cirtecmed.com

Sr. Software Engineer

Responsibilities:

  • Develops software / firmware in C / C++ for 16 and 32 bit microcontroller / DSPs
  • Real time operating system programming
  • Develops and implements software requirements specifications and algorithms
  • Analyzes and develops sensor interface
  • Develops discrete time control and feedback systems
  • Designs and implements signal processing and filtering algorithms
  • Contributes to and reviews circuit design activities such as Analog, digital and serial peripheral interfaces
  • Develops and executes design of experiments to formally test and validate requirements
  • NI platform programming (Ex: NI RIO)
  • Matlab / Simulink algorithm design and evaluation
  • Embedded Linux RTOS (Ex: Beagle bone) based control system development
  • DSP signal processing

Requirements:

Required skills :

  • BS/MS in EE / Math / Physics / CSE
  • 10+ years experience in Product Development (R&D) (Medical Device experience preferred)
  • 10+ years experience in Embedded Real Time Operating System programming
  • Experience with User Interface programming (on PC / tablet / smart phone platforms)
  • Excellent skills in communication, time management, in-depth analysis, as well as clear, concise business writing

Preferred skills :

  • Ability to work with a wide variety of people, including Manufacturing, and QA, as required accomplishing results with little overall guidance
  • Prefer strong familiarity with Class II or Class III medical devices
  • Familiarity with lab equipment (DVMS, Oscilloscopes, function generators, etc.)
APPLY NOW – or email Careers@Cirtecmed.com

Shipping & Receiving Clerk

Summary:

The Shipping & Receiving Clerk conducts 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:

  • Receives customer supplied and/or purchased materials.  This includes proper labeling, storage and documenting movement of materials.
  • Unpacks, examines and routes incoming shipments, rejects damaged items and records shortages
  • Performs ERP transactions necessary to track movement of goods prior to acceptance into inventory
  • Generates required documentation for domestic and international shipments
  • Kits materials from inventory based on job order requirements and approved procedures
  • Transacts distributed materials/inventory using ERP to ensure inventory accuracy
  • Monitors inventory levels of production consumables and places orders as necessary
  • Maintains adequate inventory of shipping materials and supplies
  • Places orders for R&D materials as assigned
  • Receives and processes all defective products returned for repair, investigation or credit
  • Schedules Shipper/Courier pickups as required
  • Maintains the work area and equipment in a clean and orderly condition
  • Follows prescribed safety regulations
  • Other duties as assigned

Requirements:

Educational:

  • High School Diploma
  • Minimum of 3-5 years shipping/receiving experience preferably in a regulated industry
  • Fluent and literate in English

Technical:

  • 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:

  • Able to lift and/or move 30 – 40 pounds

Training:

  • In house, on the job training for unique software/systems (e.g. Syteline, Master Control) to meet job requirements
  • Attend training courses as required to perform job function

Performance:

  • Decision Making & Problem Solving:  Able to make timely and accurate decisions based on available information
  • Policies and Procedures:  Able to conform to all established procedures and work activities
  • Analytical Problem Solving: Able to use a systematic approach to problem solving by researching and evaluating alternative solutions in a timely manner
  • Initiative: Able to function with minimal supervision
  • Interaction: Able to demonstrate verbal/ written communication skills when interacting in a team environment and with individuals within the organization
  • Versatility:  Able to respond to changing priorities and timelines in a timely manner with minimal disruption
APPLY NOW – or email Careers@Cirtecmed.com

Sr. Manufacturing Engineer

Summary:

The Senior Manufacturing Engineering position develops and implements 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
  • Improves 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
  • Develops, tests and cost justifies various tools and equipment recommended for manufacturing methods
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency
  • Utilizes tools associated with risk management (PFMEA/Hazard Analysis) to identify potential risks and the associated corrective actions
  • Supports required equipment qualification/process validation
  • Troubleshoots processes when defects occur.  Determine root cause and implement effective containment and countermeasures.
  • Dispositions non-conforming products and develop re-work procedures
  • Communicates with customers regarding process improvements and production changes
  • Represents manufacturing on cross functional teams
  • Participates in Kaizens and drive improvement efforts
  • Other duties as assigned

Requirements:

Educational:

  • Bachelor’s degree in Engineering or related field required
  • Advanced knowledge of manufacturing and assembly processes
  • A minimum of 5-8 years of engineering experience in a Medical manufacturing environment
  • Previous experience and the ability to direct, lead and mentor engineers with respect to company engineering procedures, new product introduction, manufacturing support and tooling
  • Excellent verbal and written communication skills
  • Fluency in English

Technical:

  • Previous experience with Class III Medical devices, FDA standards, ISO 13485 and GMP principles preferred
  • Technical leadership experience managing engineering teams, budgets and resources throughout various design phases, development and implementation of a new products
  • Experience working cross functionally with other disciplines including engineering, quality, planning and scheduling
  • Ability to lead, train, and engage manufacturing team members to reach Cirtec’s quality standards
  • 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
  • A practical and logical approach to problem solving using lean six sigma concepts
  • Interpersonal, presentation and communication skills
  • Team working and people management 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
  • An awareness of health and safety issues
  • Willingness to travel, if required

Training:

  • In house on the job training as required to meet job requirements.
  • Keep up with current industry technologies by attending training courses and conferences.

Performance:

  • Decision Making and Problem Solving:  Must be able to make clear and accurate decisions.
  • Analytical Problem Solving:  Must be able to use a systematic approach to solving problems by researching and evaluating alternative solutions.
  • Interaction:  Must be able to communicate well, both verbally and in writing, and work well in a team environment.
  • Initiative:  Able to function with minimum supervision
  • Versatility:  Able to respond to changing priorities with minimum disruption.
  • Leadership:  Must be able to lead discussions and meetings with customers and staff related to job role.
APPLY NOW – or email Careers@Cirtecmed.com

Manufacturing Technician

Summary:

Responsible for the manufacturing and assembly of sterile and non-sterile medical devices.

Responsibilities:

  • Complies with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System
  • Complies with all Good Documentation Practices (GDP) when completing all manufacturing or quality records
  • Insures that all Manufacturing Instructions / Inspection Instructions are followed when building client products
  • Maintains an orderly production line at all times while building client products
  • Provides input related to sustaining engineering regarding tools and fixtures for use in assembly, testing and packaging as required
  • Assists sustaining engineering and design engineering with equipment qualifications, process validations and design verification testing
  • Complies with company safety policies and procedures

Requirements:

Educational:

  • Associates Degree or minimum 3 – 5 years’ experience in medical device assembly
  • Must be able to read, write and speak fluent English

Technical:

  • Attention to detail
  • Knowledge of ISO & FDA requirements
  • Experience with LEAN manufacturing a plus
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action
  • Good interpersonal skills
  • Good written and verbal communication skills
APPLY NOW – or email Careers@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 Careers@Cirtecmed.com