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

Design & Development Quality Engineer

Summary:

Essential responsibilities of the Design & Development Quality Engineer are activities associated with Design Control and Design Quality Assurance during the Product Design and Development Process. Additional general Quality duties and responsibilities include, but are not limited to: statistical qualitative and quantitative data analysis; returned product complaint investigation and analysis; Manufacturing Engineering support; Training and Education; Metrology and Gage R&R; and other Quality Management Systems functions as this role is expected to provide input and contribute on Quality System improvement strategies and approach.

Reporting Relationships:

  • The Design & Development Quality Engineer position reports up to the Principal Engineer / Quality Engineering Manager / Site Leader of Quality.
  • This position may have direct-reporting and/or supervisory responsibilities for daily activities of Contract Personnel and/or Quality Technicians (responsibility dependent on geographic organizational structure).

Responsibilities:

Product / Process Development activities:

  • Author and execute Quality Plans for Product Design and Development projects.
  • Initiate and/or consult in the development and/or update of Risk Management FMEA 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 and acceptance criteria.
  • 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.

Ensure FDA and ISO Compliance in all areas:

  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NMR’s.
  • Provide statistical data / 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.
  • Other duties as assigned.

Qualifications:

Education:

  • Bachelor of Science Degree in Engineering, Manufacturing Design, Biomedical or related Technical discipline.
  • Advanced Degree preferred.

Technical: 

  • Minimum of 3 years of experience in a regulated manufacturing environment.
  • Experience with metal stamping processes.
  • 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 Manufacturing Process tools/methodologies including: Process Change Assessment, Risk Management (Hazard Analysis), Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation.
  • Design Controls / 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.

Expectations:

  • 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

Quality Engineer

Summary:

Essential responsibilities of the Quality Engineer are activities associated with Quality support of continuous improvement and continuation engineering for sustaining manufacturing operations. Additional general Quality duties and responsibilities include, but are not limited to: statistical qualitative and quantitative data analysis; returned product complaint investigation and analysis; Manufacturing Engineering support; Training and Education; Metrology and Gage R&R; and other Quality Management Systems functions as this role is expected to provide input and contribute on Quality System improvement strategies and approach.

Reporting Relationships:

  • The Quality Engineer position reports up to the Quality Engineering Manager or Site Leader of Quality.
  • This position may have direct-reporting and/or supervisory responsibilities for daily activities of Contract Personnel and/or Quality Technicians (responsibility dependent on geographic organizational structure).

Responsibilities:

Product / Process Development activities:

  • Author and execute Quality Plans for product / process improvement projects / programs.
  • Initiate and/or consult in the update of Process / Product Risk Management FMEA and Hazard Analysis documentation in cooperation with cross-functional engineering teams.
  • 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 and acceptance criteria.
  • Author, review and/or approve documentation for Process and Design Change activities as well as Validation / Verification oversight and/or test execution in cooperation with cross-functional engineering teams per project requirements.
  • Assist in qualification activities associated with supplier/vendor process characterization requirements for projects, to include audits and assessments.
  • Represent Quality Engineering in program / project phase reviews throughout the development of manufacturing processes and process improvement initiatives.

Ensure FDA and ISO Compliance in all areas:

  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NMR’s.
  • Provide statistical data / 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.
  • Other duties as assigned.

Qualifications:

Education:

  • Bachelor of Science Degree in Engineering, Manufacturing Design, Biomedical or related Technical discipline.
  • Advanced Degree preferred.

Technical: 

  • Minimum of 3 years of experience in a regulated manufacturing environment.
  • Experience with metal stamping processes.
  • 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 Manufacturing Process tools/methodologies including: Process Change Assessment, Risk Management (Hazard Analysis), Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation.
  • Design Controls / 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.

Expectations:

  • 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

Director of Supply Chain & Strategic Sourcing

Summary:

The Director, Supply Chain develops the Supply Chain Management strategy and builds the processes which ensure the organization’s readiness to meet company objectives. The person in this role leads a multi-functional team to provide compliance with cGMP requirements and create stability in planning and adherence to schedule in a service oriented environment where flexibility and responsiveness towards customers as well as security of supply / delivery performance are crucial differentiators. In addition, the Director, Supply Chain will sit on the site’s leadership team and interact with the other directors, site General Manager and senior corporate leaders to set direction, drive change, and execute on deliverables that meet the short term tactical needs and longer term ambition of the site and Cirtec as a whole.

Responsibilities:

  • Develop the Supply Chain Management strategy and build the processes which ensure the organization’s readiness to meet company objectives.
  • Build and maintain all Supply Chain Management supporting systems. Manage the Demand and Supply Planning group.
  • Responsible for enhancing and executing integrated Sales and Operations Plans (operational and tactical level) processes including maintaining the capacity models.
  • Oversight of customer service processes; warehouse operations and distribution; the management and optimization of procurement activities; and management and optimization of packaging systems engineering activities.
  • Manage and optimize processes for forecasting and invoicing customers.
  • Leadership of people to implement change, understand consequences and obtain commitment through coaching, training and clear objective setting to meet the site’s short term needs and long term ambition.
  • Develop members of the department to be key leaders within the organization.
  • Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
  • 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:

  • BS/BA in a related field required (and MBA preferred).
  • 8-10+ years relevant manufacturing experience required; pharmaceutical experience is a plus.
  • Solid knowledge of Supply Chain Management concepts and processes.
  • People management/development skills required.
  • Must be able to handle ambiguity.
  • Must be able to interact with and influence the most senior levels of the organization.
  • Change management skills important.
  • Demonstrated business acumen (i.e., ability to understand key aspects of the company’s business strategy).
  • Collaborative; encourages cross-functional cooperation and builds strong working relationships between the supply chain and operating teams.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Project Manager

Summary:

This position is primarily responsible for executing the project plan and managing the project initiative to established budget and timeline. Coordinate the design, development, documentation, and validation of complex new and modified customer products.

Responsibilities:

  • Organize a project plan for complex projects to satisfy milestones and deadlines with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets internally and externally. Serve as principal contact with clients. Coordinate and direct site visits, conference calls, and day-to-day customer communication.
  • Coordinate development, validation and documentation of products and expansion of existing products, including defining requirements, timelines, and deliverables.
  • Proactively monitor the performance of assigned projects to budget and schedule to identify trends or project challenges that may impact budget and timeline. Recommend and implement corrective actions.
  • Oversee the process of preparing modified products ensuring compliance to internal and client requirements for project completion or testing and manufacturing transfer.
  • Author planning documents as required to support assigned projects.
  • Contribute to quality, design, and development activities or act as backup to engineers on assigned projects as required.
  • Assist business development with definition of project scope, timeline, and budget to support preparation of proposals, quotations, and change orders for clients.
  • Manage resources assigned to the project team to meet project goals/milestones. Work with management to ensure project has proper resources assigned.
  • Manage site transfers and ensure all validations are completed with operational success
  • Manage more than more transfer internal/external
  • Manage transfers outside the US and working with other sites

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.
  • Required to 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 with 5 years of applicable experience or equivalent.
  • Minimum 3 years in project engineering. Demonstrated ability to lead projects from early stage development to production.
  • Minimum 3 years in project transfers.
  • Minimum 7 years’ 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.

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

Facilities Manager

Summary:

This position is primarily responsible for the day-to-day implementation of policies, procedures, and programs that will assure a well-maintained facility. 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 coordinates the activities, suppliers, and manpower required for current and future needs of the facility within constraints of time, quality and cost.

Responsibilities:

  • Design, plan and manage all aspects of the facilities function for the facility, which may include but is not limited to maintenance, equipment, machinery, construction, building space allocation and layout, office services, leased properties and furnishings, and building security.
  • Plan, budget and schedule facility modifications and moves, including cost estimates, bid sheets, layouts, buildouts, and contracts for construction and acquisition.
  • Ensure all interior space requirements, building layout/footprints, architectural elements, corporate environments demands, aesthetics, department work requirements and HVAC (Heating, Ventilating, Air Conditioning) needs are consistently met and maximized.
  • Participate in negotiation of service contracts with outside suppliers
  • Ensure projects are completed within time and budget specifications
  • Maintain knowledge of current and emerging trends in technologies, techniques and approaches in space planning and allocation, and space optimization methodology
  • Enforce safety, security, and emergency guidelines
  • 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.

Qualifications:

  • Minimum 5 years’ experience in facilities management to include the following: design, construction, build out, interiors, branding, space planning, maintenance and custodial development
  • Extensive experience with supplier negotiations and supplier management
  • Strong project management skills and an ability to oversee multiple projects simultaneously
  • Excellent communication skills and leadership skills with the ability to influence multiple business partners across all levels
  • High level of customer service aptitude
  • Proven track record of resolving complex business issues and making sound decisions
  • Prior experience in complying with OSHA and ADA regulations
  • Knowledgeable in establishing and enforcing safety, emergency and security procedures
  • Experience with sustainable design or energy use reduction methods

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

Shipping & Receiving Clerk

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.
  • Kit materials from inventory based on job order requirements and approved procedures.
  • Transact distributed materials/inventory using ERP to ensure inventory accuracy.
  • Maintain adequate inventory of shipping materials and supplies.
  • 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 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

Tool Maker

Summary:

This position is primarily responsible for providing tool room support of CNC Programmer / tool making including manual drilling, milling, turning, surface grinding and general machining as required. Fabricate metal stamping stage, compound and progressive tooling. Machine jigs, fixtures and prototype tooling from sketches, Cad drawings and verbal information. Maintain and update Cam software and provide organization, cleanliness and general maintenance to all shop equipment as necessary.

Responsibilities:

  • Cam Programming experience in tool room environment utilizing Master Cam and Solid Works.
  • Strong 5 axis CNC machining background with experience in tight tolerance and hard milling.
  • Select proper tooling, edit programs and adjust speeds and feeds to optimize and achieve production plans.
  • Manufacture tools, jigs and fixtures including prototype development and procurement.
  • Maintain, repair and refurbish in house tools, jigs and fixtures.
  • Recommend and specify upgrades on shop equipment as required.
  • Assist the engineers in the conceptualization of new fixtures.
  • 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.
  • Two year technical degree in machine tool careers or equivalent work experience.
  • Must be familiar with and be able to operate, set up and maintain the following equipment: machining center, bridgeport, lathe, surface grinder, cut-off saw, inspection devices and related equipment.
  • Must be able to interpret technical drawings, blue prints, specifications and illustrations.

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

Sr. Calibration Technician

Summary:

The 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.

Reporting Relationships:

  • This position may report to a Supervisor or Quality Manager at the discretion of the Site Leader of Quality
  • This position will not have direct-reporting and/or supervisory responsibilities

Responsibilities:

This position is 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 and Maintenance
  • Inspection/Test Equipment Selection and Qualification (Metrology and Gage R&R)
  • Inspection/Test Equipment Identification and Control
  • Inspection/Test Method Planning Development
  • Gauge & Equipment procurement, planning & scheduling
  • Maintenance and continuous improvement of the Calibration System to ensure that all inspection, measurement and test equipment, including mechanical, automated, electronic inspection and test equipment, 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)
  • 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).
  • Knowledge of selection and testing methodology to define and collect data to support accuracy, reliability, and capability for purpose of measurement and test equipment qualification
  • Knowledge of Test/Inspection Method qualification and/or validation principles and processes
  • Support and reinforce Quality Best Practices and GDP/GMP behaviors and continuous improvement efforts within Cirtec Medical
  • Provide training and coaching to employees on inspection, measurement and test equipment principles, processes and methods
  • 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

Qualifications:

Required Education & Experience:

  • Associate Degree or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred)
  • Minimum 6-8 years calibration workplace experience (Medical Device area preferred)
  • Demonstrated understanding of QSR and ISO standards for Equipment Controls

Preferred Qualifications & Experience:

  • Post-Secondary Education/Training/Certification coursework (Manufacturing or Engineering discipline preferred)
  • Quality certification(s) (e.g. ASQ CQE, CQM, 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, risk management, continuous improvement, 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
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Engineering Manager

Summary:

This position is primarily responsible with 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:

  • 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.
  • Serve as secondary contact with clients; instilling confidence in our technical capabilities and quality products.
  • Ensure team is performing under the Cirtec quality system and with good engineering practices.
  • Ensure R&D, design and tooling resources are meeting project needs in both availability and talent in a multi-project environment.
  • Ensure that projects stay on schedule and are fully documented as required by medical device regulatory agencies.
  • Oversee the process of developing new or modified products ensuring compliance to internal, regulatory, and customer requirements.
  • Provide 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.
  • Manage day-to-day oversight of engineering support of the manufacturing operation for assigned customers after product release as necessary.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions 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.

Qualifications:

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

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 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

Mechanical Designer

Summary:

This position is primarily responsible to provide documentation support for all tooling and products for engineering and manufacturing. Documentation support includes complete detailing of all tools, jigs, gages, fixtures and product drawings on company CAD systems, AutoCad and Solid Works. To provide assistance in the conceptualization and design of prototype and process fixturing.

Responsibilities:

  • Document, detail and provide bill of materials for all tools, jigs, gages and fixtures to company defined standards.
  • Detail and/or create concept drawings of customer products as required by Engineering and/or Manufacturing to company standards.
  • Aid engineers in the conceptualization and design of fixtures.
  • Aid in the quotation process for new or modified fixtures.
  • Provide detailed CAD pictures of tooling and/or set up information in 2D and 3D as applicable for insert into Process Control Documents and Parameter Sheets.
  • Create layouts, concept drawings and miscellaneous drawings as required to support current equipment, customer inquiries, quotations and various projects as required.
  • Order and update tooling and equipment catalogs for library catalog file as required to support current equipment and tools.
  • CAD Administration – Maintain CAD database to support established design, drawing procedure by archiving old revisions, maintain the current directory structure and supporting CAD software upgrades.
  • 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.
  • Technical training or equivalent experience in computer use and CAD software-AutoCad and Solid Works.
  • Must be able to fully interpret technical drawings, blue prints, specifications and illustrations.
  • Minimum 3 years’ experience in an engineering/manufacturing environment with mechanical or tool design.
  • Understanding of good dimensioning, geometric tolerancing and CAD 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 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 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

Director of Operations

Summary:

This position is primarily responsible for the management of all manufacturing operations and related support functions, including purchasing, production planning, production operations, shipping and receiving, kitting, facilities and 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:

  • Development and implementation of strategic plans for efficient and cost effective manufacturing, logistics, and related operations. Manages the budgets for equipment expenditures and direct/indirect labor.
  • Provide leadership for the department, staff operational areas at appropriate levels with fully qualified individuals capable of performing duties to the required level of proficiency.
  • Create and nurture a continuous improvement program and culture focusing on Lean Manufacturing processes.
  • Ensure compliance with all FDA, ISO/13485 and other external/internal quality requirements as it relates to all products and services.
  • Work across departments to achieve company and departmental objectives and build teamwork. Specifically, work with other groups to achieve product and customer standards and requirements, communicating related information as necessary to the appropriate staff.
  • Identify areas in which process modifications could positively influence a reduction in operating cost and/or increased profit. Use of specific metrics to monitor and track performance.
  • Establishes production schedules and manpower planning, based on product requirements and material supply. Review production, inventory, equipment capacity and utilization regularly. Initiate change as deemed necessary to efficiency, on time delivery, product quality or customer satisfaction.
  • Develop and maintain a thorough understanding of clients and market to ensure that services and skills align with market and/or competition.
  • Establish and maintain a positive working relationship with clients and act as a liaison to ensure their expectations are met and any requests for information are responded to in a timely manner.
  • Provide leadership and direction to the operations and production staff. Establish performance requirements and monitors achievements. Direct multiple production shift operations.
  • Acquire a strong knowledge of the production processes and all associated equipment. Manage troubleshooting of manufacturing related issues, and identify resources and action plans to resolve these issues.
  • Review MRP / ERP system (Syteline) as to its applicability, recommending alternate systems where deficiencies are identified. Use ERP system to fullest capabilities to improve efficiency, reduce errors, etc.
  •  Responsible for directing and managing the manufacturing engineers in transitioning developmental product to sustained manufacturing phase.
  • Develop and implement Continuous Improvement projects.
  • 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.
  • Experience with a FDA Regulated Biotech Pharmaceutical, or Medical Device manufacturer with over 10 years’ experience and a minimum of 5 in a leadership role; clear understanding of best practice within human resources and team development.
  • Previous experience with manufacturing of Class II and preferably Class III medical devices.
  • Excellent verbal, listening and written communication skills, strong management skills and strong presentation and persuasion skills are also required. An MBA or advanced degree in engineering or related scientific field is a big plus.
  • Hands on experience with ERP systems, Syteline a plus.
  • Demonstrated ability to develop business, operational and financial strategies, plans and programs that foster the achievement of organizational objectives.
  • Ability to translate broad strategies into specific objectives and action plans.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sales Engineer

Summary:

This position is primarily responsible for combining technical knowledge with sales skills interacting directly with the customer and supporting the Business Development team. The customers are typically medical device OEM’s, and start-ups.

Responsibilities:

  • Field sales calls, maintains and develops existing customer relationships with regular phone calls and face-to-face meetings
  • Presents a consultative sales approach to determine the best solution for the customer
  • Assist Business Development team with technical sales as required
  • Follow up on leads that are determined to be house accounts or as assigned
  • Engages the appropriate internal team resources to assist with the sales process
  • Focus on the sale of electronic components and assemblies, from early stage design to custom manufacturing, utilizing the company’s vertical capabilities
  • Perform market research to determine potential customers, markets, and products
  • Assist engineering to develop proposals for design, development, and manufacturing
  • Assist in meeting sales team yearly sales projections
  • Develop and maintain communication with our employees and customers in a cooperative and professional manner
  • Be proactive in representing the customer to allow Cirtec to reach and maintain a high level of customer satisfaction
  • Prepare reports for management
  • Offers after-sales support
  • Willingness to travel up to 50%
  • Other duties as assigned

Requirements:

  • Advanced computer competency, with strong oral and written communication skills
  • Bachelor’s Degree in Engineering with strong technical background
  • 5+ years of medical device contract design and manufacturing experience
  • Technical selling experience with PCBA, thin film circuits and sensors, ASIC, and other electronic components
  • Knowledge of minimally invasive surgical devices, neuromodulation, cardiac rhythm management, and other medical electronics or implantable devices desired but not required
  • Experience with medical device software, firmware, and hardware development desired but not required
  • Familiar with CRM software like Salesforce

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Engineering Technician

Summary:

The Senior Engineering Technician works in collaboration with the development engineering team. Assisting Design and Process Engineering to develop new prototypes, processes, documentation, perform experiments and develop tooling/fixturing as needed.

Responsibilities:

  • Assemble development prototypes in a timely manner, whether independently or coordinating with a larger team of operators and technicians.
  • Provide candid feedback to engineering team when designs and/or processes can be improved.
  • Document settings, assembly techniques, etc. in a laboratory notebook using good documentation practices.
  • Draft initial process flows and manufacturing procedures.
  • Engineering Change Order creation and execution to support engineering staff.
  • Perform training to the assembly team when programs mature in the development phases.

Requirements:

  • HS Diploma/GED and 5 years relevant experience; or Associates Degree or Technical Certificate and 4 years relevant experience
  • Knowledge of a specialized or technical field relevant to position.
  • Understanding of basic cleanroom, measurement, and lab equipment
  • Mechanical aptitude for intricate assembly

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Machinist II

Responsibilities:

  • Must meet all of Level l Operator criteria
  • Maintain a no reject quality level.
  • Effectively resolve all problems that arise or seek assistance in a timely manner
  • Interacts effectively with engineering and quality individuals to solve problems.
  • Extensive knowledge of all phases of machining and equipment.
  • Demonstrates good decision making and problem solving.
  • Continually train co-workers to encourage individual growth within company
  • Ability to set up and run all jobs within the department.
  • Promote good morale and productivity.
  • Ability to increase production and streamline set-ups for optimum efficiencies and quality.
  • Ability to trouble shoot quality problems by effectively utilizing process control and corrective actions.
  • Maintain a very high level of cleanliness and organization.

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:

  • On-going job training

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

Sterilization Engineer

Summary:

This position is responsible for technical execution of activities associated with projects in the global sterilization network to improve operational efficiency, ensure predictable product flow, and enable lowest total cost of ownership.

Responsibilities:

  • Lead development review and approval of sterilization validations and product adoptions.
  • Provide technical support for in-house ethylene oxide and moist heat sterilization, maintaining flow of development and commercial products.
  • Develop and optimize sterilization cycles with the intent of improving cycle times, reducing lead times, and sterilization of new products.
  • Oversee routine bioburden and environmental monitoring programs.
  • Develop Standard Operating Procedures, Manufacturing Work Instructions, Test Methods and provide on-site training to applicable technical staff.
  • Establish preventive maintenance program for sterilization, requalification, product loading, and material handling.
  • Develop and maintain knowledge of applicable industry standards for sterilization.
  • Assure compliance with Federal, State and local safety/environmental regulations.  Assist in environmental testing and reporting.
  • Other duties, and responsibilities as assigned.

Requirements:

  • BS in Engineering; Chemical, Mechanical, Biomedical or equivalent.
  • 3+ years in medical device sterility assurance, sterilization operations or testing environment.
  • In depth knowledge of industrial sterilization modalities (i.e. Ethylene Oxide and Moist Heat sterilization).
  • Expert knowledge of GMP compliance (FDA, BS/EN, ANVISA, etc.)
  • Knowledge of manufacturing and assembly processes.
  • Strong leadership skills.
  • Excellent verbal and written communication skills.
  • Verbal and written fluency in English.

Technical:

  • Previous experience with Class II Single-Use and Class III Medical devices 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.
  • 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 and project management skills and the ability to work to tight deadlines and finite deliverables.
  • An awareness of health and safety issues associated to sterilization manufacturing environments.
  • Willingness and capability to travel, as required (estimated <5%).

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.
  • 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 CareersAtCirtec@Cirtecmed.com

Sr. Process Engineer

Summary:

Defines, develops, designs, and validates manufacturing processes, also performs modification of existing processes for medical device assemblies and components. Works within the engineering department suggesting areas for improvements positively impacting product quality, cost and delivery.

Responsibilities:

  • Creates and improves processes pertaining to:
    • Feasibility Builds, Manufacturing, and Inspection
    • Planning and executing process characterization activities, through tools i.e. design experiments
    • Equipment selection
    • Process development and documentation
    • Component validation and verification samples and testing
    • Develops and executes IQ, OQ and PQ protocols and reports
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical Builds
    • Process Validation
    • Assembly and Component Process flow layouts
  • Involved with manufacturing and product design teams to:
    • Facilitate and create processes
    • Implement systems to produce a quality and cost effective product
    • Improve Labor cycle times
  • Improve existing processes for boosting productivity, quality and cost
  • Assist with the preparation of proposals and quotes for customers
  • Creates process risk assessments
  • Assesses safety requirements ensuring they are part of the process for the builder, user and customer
  • Prepares Engineering Change Orders for processes, components, and Bill of materials
  • Performs and advises Corrective and Preventive Action tasks
  • Other duties as assigned

Requirements:

  • FDA cGMP principles and practices
  • Must have 3 or more years’ experience of medical device process or manufacturing engineering
  • 2 years’ experience with bonding techniques. I.E. – Adhesives, Chemical, Laser, Resistance welding
  • Familiarity with biocompatible materials
  • Exposure to Pro-E / CREO and or SolidWorks preferred
  • Strong computer skills associated with Microsoft software
  • Demonstrated ability to interpret technical drawing, blueprints, specification and illustrations
  • Possess a keen attention to detail
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Demonstrated ability for systematic problem solving, DMAIC
  • Maintains performance with changing priorities under minimal supervision
  • Must maintain high ethical standards
  • Must be able to make clear and accurate decisions
  • Ability to learn and apply new technology
  • Must have a BS degree in relevant engineering discipline with a minimum 3 years of related engineering experience
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Chandler, AZ

Senior Test Engineer

Summary:

Senior Test Engineer develops and maintains test and evaluation solutions for Cirtec ASIC products They can develop/debug test solutions on the selected test platforms used by Cirtec such as D10, ASL1K/3K, and/or Catalyst. Must be able to manage 3rd party test development vendors.

Responsibilities:

  • Test support of all IC products.
  • Test Vendor Management.
  • Owner of test specifications, test verification plans, test verification reports, test release.
  • Provide test support for a product or range of products through all phases of product development and manufacturing.
  • Work closely with design engineers during bring-up and production release to develop robust test and evaluation solutions.
  • Communicate technical product status to management.
  • Attend regular meetings (both internal and customer) to discuss test development status.

Requirements:

  • BS or MS in an engineering discipline.
  • A minimum of 5 years related IC test experienced required.
  • Detailed understanding of diagnostic, product test, failure analysis and debug techniques.
  • Solid understanding of circuit design, semiconductor process and device physics.
  • Self-starter with strong leadership, communication skills and demonstrated problem solving ability.
  • Bench test/evaluation experience.
  • Physical Requirements: Long hours at the computer, light lifting such as monitors and key boards.
  • Travel Requirements: Moderate travel required to US Based and/or offshore test houses to develop code, debug or release test solutions to production.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sales Engineer

Summary:

This position is primarily responsible for combining technical knowledge with sales skills interacting directly with the customer and supporting the Business Development team. The customers are typically medical device OEM’s, and start-ups.

Responsibilities:

  • Field sales calls, maintains and develops existing customer relationships with regular phone calls and face-to-face meetings
  • Presents a consultative sales approach to determine the best solution for the customer
  • Assist Business Development team with technical sales as required
  • Follow up on leads that are determined to be house accounts or as assigned
  • Engages the appropriate internal team resources to assist with the sales process
  • Focus on the sale of electronic components and assemblies, from early stage design to custom manufacturing, utilizing the company’s vertical capabilities
  • Perform market research to determine potential customers, markets, and products
  • Assist engineering to develop proposals for design, development, and manufacturing
  • Assist in meeting sales team yearly sales projections
  • Develop and maintain communication with our employees and customers in a cooperative and professional manner
  • Be proactive in representing the customer to allow Cirtec to reach and maintain a high level of customer satisfaction
  • Prepare reports for management
  • Offers after-sales support
  • Willingness to travel up to 50%
  • Other duties as assigned

Requirements:

  • Advanced computer competency, with strong oral and written communication skills
  • Bachelor’s Degree in Engineering with strong technical background
  • 5+ years of medical device contract design and manufacturing experience
  • Technical selling experience with PCBA, thin film circuits and sensors, ASIC, and other electronic components
  • Knowledge of minimally invasive surgical devices, neuromodulation, cardiac rhythm management, and other medical electronics or implantable devices desired but not required
  • Experience with medical device software, firmware, and hardware development desired but not required
  • Familiar with CRM software like Salesforce

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

IC Design Engineer

Job Duties:

Perform duties in Analog circuit design w/skills in CMOS, IDACs, Oscillators, PORs, biphasic pulse generators, bandgaps circuits, debugging silicon, Spectre, ADE XL, & Monte-Carlo Simulations.

Requirements:

MS in Electrical Engineering required.

Mail applications to:

Cirtec Medical Corporation
60 N McClintock Dr., #1
Chandler, AZ  85226

Or email to: James.McDonald@cirtecmed.com

Opportunities in Enfield, CT

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.

Qualifications:

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 Qualification & 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:

The employee will normally be required to sit or stand for long periods of time. The employee may be required to lift up to 50 pounds without restriction.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Business Services Manager

Summary:

This position is primarily responsible in ensuring all business service and support activities are executed in a timely and effective manner so as to support core business activities.

Responsibilities:

  • Effectively manage the financial health and well-being of sustaining programs in the Enfield CT location.
  • Work with department heads and other key stakeholders to develop proposals necessary to support these sustaining programs.
  • Provide timely, accurate quotes for delivery to Sales and Project Managers on sustaining programs.
  • Follow the quote during the steps of negotiations with the customer through completion.
  • Assist with sales pipeline management by working with key sustaining customers to obtain an accurate 12 month rolling forecast.
  • Work with Business Development and other key stakeholders to manage and drive Quarterly Business Reviews with customers.
  • Review key program metrics to ensure profitability. This includes but is not limited to evaluating actual vs. assumed scrap rates, actual vs. assumed cycle times and actual vs. assumed bill of materials.
  • Work with Business Development and Pricing Coordinator to reprice existing programs when necessary. Support customer needs internally within Cirtec Enfield to ensure high customer satisfaction rates.
  • Other responsibilities as assigned.

Qualifications:

  • 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.
  • 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 CareersAtCirtec@Cirtecmed.com

Quality Control Inspector Level 2

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

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.

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.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Control Inspector-2nd 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.

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.
  • Other duties as assigned.

Qualifications:

  • Be able to read, write and speak fluent English.
  • High school diploma-GED.
  • Certificate/s of training related to this field of work (medical or quality assurance.
  • A minimum of 2 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.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Engineer

Summary:

This position is primarily responsible for monitoring and auditing the quality of all manufactured goods in a medical device industry. Will work to not only find defects, but also to find the cause of the defect and develop a solution. Interact with customers and suppliers in support of engineering projects.

Responsibilities:

  • Provide Quality Engineering support for engineering project development.
  • Provide Quality Project Management support as needed for product transfers from development to validation.
  • Validation System Owner responsible for the development and management of the validation master plan along with the validation determination.
  • Develop and maintain Validation Standard Operating Procedures.
  • Develop and maintain project Quality Plan for assigned projects.
  • Develop protocols, perform statistical analyses, and write reports for validations and formal process development, which requires quality-engineering involvement such as D Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.
  • Provide Quality Engineering support for manufacturing.
  • CAPA (Corrective and Preventative Action) system owner responsible for the support of the corrective action system and procedures.
  • Interact with customers and suppliers to resolve CAPA investigations and in support of manufacturing.
  • Provide Quality Support for the disposition of material.
  • Provide Quality Project Management Support as needed for product transfers from validation to production.
  • Vendor approval and maintain and assess vendor performance data (i.e. SCAR/on time).
  • Review and document procedure changes for quality requirements and compliance with the quality system.
  • Develop quality systems and procedures as needed.
  • Audit support for third party audits, customer audits and internal audits.
  • Support the implementation of continuous improvement initiatives for production processes.
  • Develop and maintain production quality control plans.
  • Initiate and maintain SPC (Statistical Process Control) for production processes.
  • Provide initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE (Design of Experiment as applicable.
  • Comply with all work rules including those pertaining to safety, health, quality and Cirtec policies.
  • Back up to Quality Systems Administrator.
  • Perform other duties as necessary. 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:

  • Analyze and process Information, Promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures, Supports Innovation.
  • Bachelors of Science or equivalent, preferably in an engineering discipline.
  • Minimum experience in medical/manufacturing environment: 2 years (BS) OR 4 years (AS) OR 7 years (ND).
  • 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.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Technician-2nd Shift

Summary:

This position is primarily responsible for the manufacturing and assembly of sterile and non-sterile medical devices.

Responsibilities:

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

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

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. 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 II & 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/sustained production. This position also administers standard processes and programs to ensure effective, timely and accurate standards and customer satisfaction.

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, test and cost justify various tools and equipment recommended for manufacturing methods.
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
  • Utilizing tools associated with risk management (PFMEA/Hazard Analysis) to identify potential risks and the associated corrective actions.
  • Supporting required equipment qualification/process validation.
  • Troubleshoot 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 Kaizens and drive 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.

Requirements:

  • 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.
  • Previous experience with Class II & III Medical devices, FDA standards, ISO 13485 and GMP principles preferred.
  • 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, along with organizational and time management skills
  • The capacity to work well under pressure and take on new challenges.
  • Project management skills and the ability to work to tight deadlines.
  • Willingness to travel, if 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

Sr. Process Development Engineer

Summary:

Works 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
  • Assists with preparation of proposals and quotations for clients; interfaces as needed to resolve questions in a timely manner
  • Assists in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Tracks and communicates project status, plans, issues, timelines, action items, and budgets.
  • Provides guidance and direction to coworkers on areas of technical expertise
  • Troubleshoots production processes as required
  • Evaluates and selects 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

Requirements:

  • Willingness to travel, if required.
  • Must maintain high ethical standard
  • Must demonstrate good organizational skills
  • Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures

Educational:

  • Must be able to read, write and speak fluent English.
  • A Bachelor’s degree in an engineering discipline with 5 years of relevant experience; Associate’s degree in an engineering discipline w/10 years of relevant experience; or equivalent

Technical:

  • 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
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Los Gatos, CA

Manufacturing Engineer

Summary:

The Manufacturing Engineering in our Los Gatos, CA office is primarily responsible for developing and implementing robust cost-effective manufacturing processes and methods in accordance with product specifications and Class II/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, test and cost justify various tools and equipment recommended for manufacturing methods.
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency. Utilizing tools associated with risk management (PFMEA/Hazard Analysis) to identify potential risks and the associated corrective actions.
  • Supporting required equipment qualification/process validation.
  • Troubleshoot 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 improvement efforts.
  • Other duties as assigned.

Qualifications:

  • Bachelor’s degree in Engineering or related field
  • Minimum 5 years of Manufacturing Engineering experience with Class II or III Medical devices, FDA standards, ISO 13485 and GMP principles
  • Verbal and written fluency in English
  • Knowledge of medical device manufacturing and assembly processes
  • Excellent verbal and written communication skills
  • Strong leadership, teamwork and people management skills
  • 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
  • Strong ability to understand a range of engineering functions and procedures
  • Interpersonal, presentation and communication skills
  • Ability to work well under pressure and take on new challenges
  • Strong organizational and time management skills
  • Project management skills and the ability to work to tight deadlines
  • Awareness of health and safety issues, and related best practices
  • Willingness to travel, if required
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

TEMP Accounting Assistant- PT

Summary:

This is a PART-TIME (24 hours a week) TEMPORARY position (90-120 days). This position is responsible to perform all duties with accuracy and promptness with an emphasis on quality and courtesy. Ability to handle and maintain highly confidential information in an appropriate manner. Provide support to both internal and external customers. Process all accounts payable invoices and payments. Assume responsibility for all accounts payable reporting, reconciliations, and accounting.

Responsibilities:

  • Match Accounts Payable invoices to receivers or purchase orders, enter invoices into the system, process all payments, file all electronic and paper documents, and maintain accounts payable reports.
  • Proactively resolve account discrepancies
  • Mail- sort and distribute incoming mail; prepare outgoing mail. Monitor postage meter balance and any related technical issues.
  • Provide support to accounting and management team members as needed
  • Special project support and Ad-hoc reporting
  • Perform other related duties as directed
  • 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.

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:

  • 2 or more years of AP experience with an ERP/Accounting system, manufacturing environment preferred
  • Proficient in MS office (Word, Outlook, etc.)
  • Advanced Excel experience preferred
  • Superior attention to detail, organization skills and follow through on tasks
  • Strong communication skills and ability to interact with internal partners
  • Ability to effectively work under multiple priorities and deadlines
  • Proactive problem solving skills
  • Ability to maintain confidentiality
  • Willingness to multi-task, perform a variety of duties and assist with various functions
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sales Engineer

Summary:

This position is primarily responsible for combining technical knowledge with sales skills interacting directly with the customer and supporting the Business Development team. The customers are typically medical device OEM’s, and start-ups.

Responsibilities:

  • Focus on the sale of nitinol tubing and secondary processes
  • Secure customer forecasts and communicate customer requirements to the Production department
  • Follow up on leads that are determined to be house accounts
  • Support the Business Development team with technical sales as required
  • Engage the appropriate internal resources to assist with the sales process
  • Perform market research to target appropriate devices and potential customers
  • Assist engineering with the preparation of device development and assembly proposals
  • Collaborate with the sales team to meet yearly sales projections
  • Be proactive in creating a high level of customer satisfaction
  • Identify ways to grow the business
  • Prepare reports for management
  • Provide after-sales support
  • Willingness to travel up to 50%
  • 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 with strong technical affinity
  • 3+ years of professional experience with medical devices or contract manufacturing
  • Knowledge of laser-cutting related to stent and/or heart valve frames
  • Advanced computer competency
  • Familiar with CRM software like Salesforce

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 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

Document Control Specialist

Summary:

The Document Control Specialist in our Los Gatos, CA office will be responsible for ensuring operational adherence and compliance to Cirtec Medical’s Quality Management System (QMS) requirements for Documentation Systems, Control and Record Retention.

Reporting Relationships:

  • The position reports up to the Quality Manager / Site Leader of Quality.
  • This position will not have direct-reporting and/or supervisory responsibilities.

Responsibilities:

This position is responsible for the execution and coordination of system elements within the Quality Systems & Control functional Team. Specific elements of the QMS, as part of daily essential duties and responsibilities, may include, but are not limited to:

  • Design Change Controls (Engineering Prints/Specifications)
  • Production Engineering Change Controls (ECO/ECN)
  • Product Library Management (PLM) Controls
  • Quality System Document Change Control (Policies, Procedures, SOPs, WIs, Forms, and Templates),
  • Internal & External Auditing Documentation Support
  • Training and Education, and Regulatory Compliance

Additional duties and responsibilities include, but are not limited to:

  • Manage the day to day requirements of the documentation system:
    • Create and maintain processes for documentation system requirements
    • Process Engineering Change Orders (ECO/ECN), Manufacturing Change Requests (MCR), Deviations
    • Work with product development and sustaining engineers to ensure compliance with internal processes and regulatory requirements
    • Coordinate all document releases and revisions including approval, release and retrieval of obsolete documents in manuals and on the network
    • Maintain all quality system documents in hard copy and electronic form for use by all Cirtec Medical functional areas
  • Corrective/Preventative Actions (CAPA): Provide support to Quality personnel in executing CAPA tasks
  • External Audits: Provide support during customer and registration quality audits
  • Internal Auditing:
    • Manage the internal audit system to ensure all internal audits are performed as scheduled
    • Draft, review and approve internal audit reports
    • Ensure all internal audit findings are cataloged and have appropriate follow-up activity
    • 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
  • Training and Education: Provide training to cross-functional departmental personnel regarding Quality Management System elements, controls, processes and procedures
  • Regulatory Compliance: Ensure compliance to regulatory standards and requirements as applicable
  • Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System and its requirements
  • Must be able to present and/or communicate the status of materials at any time to the Supervisor/Manager
  • 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

Qualifications:

Required Education & Experience:

  • High School Diploma, GED, or equivalent directly transferable work experience (Manufacturing or Engineering discipline preferred)
  • Minimum of 1-4 years of experience in a professional workplace environment
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.)

Preferred Qualifications & Experience:

  • Post-Secondary Education/Training/Certification coursework (Manufacturing or Engineering discipline preferred)
  • Quality certification(s) (e.g. ASQ CQT, CQI, 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 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

Expectations:

  • Policies & Procedures: Must consistently abide by and conform to all established Cirtec Medical policies and procedures.
  • Decision Making & Problem Solving: Must consistently take action in solving problems while exhibiting judgment and a realistic understanding of the issue(s) and able to make rational and justifiable technical decisions without jumping to conclusions inappropriately.
  • Interaction: Must consistently communicate well, both verbally and in writing, while working in a team environment of cooperation and collaboration.
  • Initiative: Must consistently be capable of completing assigned tasks while operating independently and/or without supervision.
  • Versatility: Must consistently be capable of responding and adapting to changing priorities with minimum disruption and setting work guidance/direction for self and other when required.

Work Environment:

  • The employee will normally be required to work in a standard general office space and/or inside a temperature and humidity controlled cleanroom environment.
  • The employee will normally be required to sit or stand for long periods of time.
  • The employee may be required to lift up to 50 pounds without restriction.
  • 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.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Lowell, MA

Production Planner

Summary:

This position is primarily responsible for flow of materials for assigned product lines and labor hour adjustments. This includes ensuring that bills of material are accurate, all materials are issued to the production orders.

Responsibilities:

  • Review custom bill of materials and routings to ensure accuracy.
  • Review and plan production requirements to ensure dates are accurate and match customer sales order due dates. Confirm and transfer when needed.
  • Review and plan production orders to ensure required dates are adequate. Release orders when necessary.
  • Review production orders for completeness and know material shortages before releasing to Production. Review and coordinate short sheet with Production and Purchasing.
  • Maintain estimated material list as needed to ensure all materials are issued to the production orders in a timely fashion.
  • Request drawings for production units and assembly production packages for the various product lines.
  • Adjust labor hour clocking based on Foreman and Production Manager feedback
  • Assist in new product introduction to manufacturing.
  • Assist in the closing of production orders.
  • Other assignments as designated.

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:

  • Proven expertise with production planning, scheduling and expediting.
  • Strong problem solving skills.
  • Be able to handle multiple tasks –while maintaining accuracy Strong written, verbal, analytical and interpersonal skills.
  • Computer skills: MRP system experience, knowledge of Microsoft Office.
  • Associates Degree in Business Administration or equivalent combination of education and experience.
  • 3 years production planning, scheduling and expediting experience.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Technician I - 1st Shift

Summary:

Under limited supervision, operates a variety of wafer fab equipment in a cleanroom manufacturing environment. May assist in production process development. Job requires significant standing, and working with chemicals including solvents and etchants.

Hours: 5:00 AM – 3:30 PM Monday through Thursday

Responsibilities:

  • Reads specification drawings and process documents
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Able to work with microscopes and vision systems for extended amounts of time
  • Works with small devices to load fixtures and process equipment
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Utilizes ERP system “JobBOSS” to document and execute transactions.
  • Ensures adherence to clean room protocol and follows all safety requirements/regulations.
  • Performs related duties as directed.

Qualifications:

EDUCATION: HS diploma or equivalent

EXPERIENCE: 1-3 years’ microelectronics production, cleanroom environment

SPECIALIZED KNOWLEDGE/ABILITIES:

  • Operates a variety of machines and equipment, performs set-ups, and uses precision measuring devices (e.g. Vernier, calipers, micrometers, microscopes).
  • Able to stand for 10 hours per day
  • Able to handle fragile material on a regular basis
  • Able to use microscopes for extended period of time

We offer equal employment opportunity to all applicants for employment and all employees regardless of sex, sexual orientation, age, race, color, religion, national origin, ancestry, veteran status, disability, or any other status protected by applicable law.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Technician I - 2nd Shift

Summary:

Under limited supervision, operates a variety of wafer fab equipment in a cleanroom manufacturing environment. May assist in production process development. Job requires significant standing, and working with chemicals including solvents and etchants.

Hours: 3:30 PM – 1:30 AM Monday through Thursday

Responsibilities:

  • Reads specification drawings and process documents
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Able to work with microscopes and vision systems for extended amounts of time
  • Works with small devices to load fixtures and process equipment
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Utilizes ERP system “JobBOSS” to document and execute transactions.
  • Ensures adherence to clean room protocol and follows all safety requirements/regulations.
  • Performs related duties as directed.

Qualifications:

EDUCATION: HS diploma or equivalent

EXPERIENCE: 1-3 years’ microelectronics production, cleanroom environment

SPECIALIZED KNOWLEDGE/ABILITIES:

  • Operates a variety of machines and equipment, performs set-ups, and uses precision measuring devices (e.g. Vernier, calipers, micrometers, microscopes).
  • Able to stand for 10 hours per day
  • Able to handle fragile material on a regular basis
  • Able to use microscopes for extended period of time

We offer equal employment opportunity to all applicants for employment and all employees regardless of sex, sexual orientation, age, race, color, religion, national origin, ancestry, veteran status, disability, or any other status protected by applicable law.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Technician I - Weekend 1st Shift

Summary:

Under limited supervision, operates a variety of wafer fab equipment in a cleanroom manufacturing environment. May assist in production process development. Job requires significant standing, and working with chemicals including solvents and etchants.

Hours: 5:00 AM – 3:00 PM Friday through Sunday 

Responsibilities:

  • Reads specification drawings and process documents
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Able to work with microscopes and vision systems for extended amounts of time
  • Works with small devices to load fixtures and process equipment
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Utilizes ERP system “JobBOSS” to document and execute transactions.
  • Ensures adherence to clean room protocol and follows all safety requirements/regulations.
  • Performs related duties as directed.

Qualifications:

EDUCATION: HS diploma or equivalent

EXPERIENCE: 1-3 years’ microelectronics production, cleanroom environment

SPECIALIZED KNOWLEDGE/ABILITIES:

  • Operates a variety of machines and equipment, performs set-ups, and uses precision measuring devices (e.g. Vernier, calipers, micrometers, microscopes).
  • Able to stand for 10 hours per day
  • Able to handle fragile material on a regular basis
  • Able to use microscopes for extended period of time

We offer equal employment opportunity to all applicants for employment and all employees regardless of sex, sexual orientation, age, race, color, religion, national origin, ancestry, veteran status, disability, or any other status protected by applicable law.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Technician I - Weekend 2nd Shift

Summary:

Under limited supervision, operates a variety of wafer fab equipment in a cleanroom manufacturing environment. May assist in production process development. Job requires significant standing, and working with chemicals including solvents and etchants.

Hours: 3:00 PM – 1:00 AM Friday through Sunday

Responsibilities:

  • Reads specification drawings and process documents
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Able to work with microscopes and vision systems for extended amounts of time
  • Works with small devices to load fixtures and process equipment
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Utilizes ERP system “JobBOSS” to document and execute transactions.
  • Ensures adherence to clean room protocol and follows all safety requirements/regulations.
  • Performs related duties as directed.

Qualifications:

EDUCATION: HS diploma or equivalent

EXPERIENCE: 1-3 years’ microelectronics production, cleanroom environment

SPECIALIZED KNOWLEDGE/ABILITIES:

  • Operates a variety of machines and equipment, performs set-ups, and uses precision measuring devices (e.g. Vernier, calipers, micrometers, microscopes).
  • Able to stand for 10 hours per day
  • Able to handle fragile material on a regular basis
  • Able to use microscopes for extended period of time

We offer equal employment opportunity to all applicants for employment and all employees regardless of sex, sexual orientation, age, race, color, religion, national origin, ancestry, veteran status, disability, or any other status protected by applicable law.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Assurance Technician - 1st Shift

Summary:

The Quality Assurance Technician is responsible for monitoring the production process to assure that parts are being manufactured on the production line per procedures and specifications. Monitoring includes visual inspection of employee production and employee compliance to procedures.

Hours: 5:00 AM – 3:30 PM Monday through Thursday

Responsibilities:

  • Become proficient in the operation of all production equipment and participate in process development and equipment/process qualification activities.
  • Develop a strong knowledge of all equipment and process parameters.
  • Monitor all production process steps and production operators to ensure that documented procedures are followed and process parameters are correct. Update shift checklist(s) accordingly.
  • Participate in the creation and documentation of process procedures and operating procedures as required.
  • Execute and document qualifications for new equipment and/or processes, and perform measurements and reporting of those qualifications.
  • Perform inspection and measurement of in-process and finished product using various measurement tools and microscopes as required.
  • Participate in the creation and maintenance of training documents.
  • Train new employees, and maintain technician training records.
  • May act as shift/group leader in his/her absence.
  • Perform other duties as assigned.

Qualifications:

  • Knowledge of Microsoft Office – Word, Excel, Access, PowerPoint, Outlook, etc.
  • Experience working in a cleanroom environment and working with microscopes.

We offer equal employment opportunity to all applicants for employment and all employees regardless of sex, sexual orientation, age, race, color, religion, national origin, ancestry, veteran status, disability, or any other status protected by applicable law.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Assurance Technician - 2nd Shift

Summary:

The Quality Assurance Technician is responsible for monitoring the production process to assure that parts are being manufactured on the production line per procedures and specifications. Monitoring includes visual inspection of employee production and employee compliance to procedures.

Hours: 3:30 PM – 1:30 AM Monday through Thursday

Responsibilities:

  • Become proficient in the operation of all production equipment and participate in process development and equipment/process qualification activities.
  • Develop a strong knowledge of all equipment and process parameters.
  • Monitor all production process steps and production operators to ensure that documented procedures are followed and process parameters are correct. Update shift checklist(s) accordingly.
  • Participate in the creation and documentation of process procedures and operating procedures as required.
  • Execute and document qualifications for new equipment and/or processes, and perform measurements and reporting of those qualifications.
  • Perform inspection and measurement of in-process and finished product using various measurement tools and microscopes as required.
  • Participate in the creation and maintenance of training documents.
  • Train new employees, and maintain technician training records.
  • May act as shift/group leader in his/her absence.
  • Perform other duties as assigned.

Qualifications:

  • Knowledge of Microsoft Office – Word, Excel, Access, PowerPoint, Outlook, etc.
  • Experience working in a cleanroom environment and working with microscopes.

We offer equal employment opportunity to all applicants for employment and all employees regardless of sex, sexual orientation, age, race, color, religion, national origin, ancestry, veteran status, disability, or any other status protected by applicable law.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Assurance Technician - Weekend 2nd Shift

Summary:

The Quality Assurance Technician is responsible for monitoring the production process to assure that parts are being manufactured on the production line per procedures and specifications. Monitoring includes visual inspection of employee production and employee compliance to procedures.

Hours: 3:00 PM – 1:00 AM Friday through Sunday

Responsibilities:

  • Become proficient in the operation of all production equipment and participate in process development and equipment/process qualification activities.
  • Develop a strong knowledge of all equipment and process parameters.
  • Monitor all production process steps and production operators to ensure that documented procedures are followed and process parameters are correct. Update shift checklist(s) accordingly.
  • Participate in the creation and documentation of process procedures and operating procedures as required.
  • Execute and document qualifications for new equipment and/or processes, and perform measurements and reporting of those qualifications.
  • Perform inspection and measurement of in-process and finished product using various measurement tools and microscopes as required.
  • Participate in the creation and maintenance of training documents.
  • Train new employees, and maintain technician training records.
  • May act as shift/group leader in his/her absence.
  • Perform other duties as assigned.

Qualifications:

  • Knowledge of Microsoft Office – Word, Excel, Access, PowerPoint, Outlook, etc.
  • Experience working in a cleanroom environment and working with microscopes.

We offer equal employment opportunity to all applicants for employment and all employees regardless of sex, sexual orientation, age, race, color, religion, national origin, ancestry, veteran status, disability, or any other status protected by applicable law.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Equipment Maintenance Technician

Summary:

Responsible for performing all preventive and corrective maintenance on equipment located in the fab and plating areas. It is expected that the equipment maintenance technician works independently and is capable of being successful in a matrix organization.

Responsibilities:

  • Responsible for preventive and corrective maintenance on all fab / plating area tool sets, including component disassembly / assembly / repair
  • Responsible for identifying needed parts for repairs / preventive maintenance
  • Properly handle and store chemicals and hazardous waste
  • Maintain written logs of maintenance and repairs in our online system
  • Perform other duties as assigned by your supervisor

Requirements:

  • Minimum of 4 years’ experience in performing preventive 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 communication skills
  • Manual dexterity and visual acuity are required to perform responsibilities
  • Must be able to lift 60lbs
  • Must be willing to work some weekends, alternating coverage with other maintenance techs
  • Must be legally authorized to work in the United States
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