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Careers @ MGC Diagnostics


About Us:

MGC Diagnostics Corporation is a leader in providing innovative technology for cardiorespiratory diagnostics. We recognize that our past, present and future success depends upon the capabilities of our employees, and seek to attract and retain skilled people with an interest in contributing to MGC Diagnostics' business goals. 

Why Work at MGC Diagnostics?

Why Work at MGC Diagnostics? We care for and promote our employees through education, training & development, fitness and wellness programs, strong social responsibility ideals, and a generous benefits package. Employees enjoy regular company events, as well as many opportunities to give back to the community.

Our Core Values:

Our strength is our people. We believe we have the best team in the industry, delivering best-in-class service and support to our customers around the world, including those "customers" within our walls - our employees.

We value:

  • Collaboration - doing great things together
  • Innovation - searching for better solutions
  • Contribution - making a positive impact
  • Fun - taking fun seriously

Open Positions

  • Position
    Location
    Date Posted
  • Primary Purpose

    The Quality Systems Analyst/Auditor is responsible for ensuring that the Quality Management System (QMS) for our medical devices meets the required standards of regulatory bodies, both domestic and international. This role encompasses internal audit activities, external standards management, CAPA ownership and support, label management, and gap assessments related to global medical device regulations.

    KEY RESPONSIBILITIES AND ESSENTIAL FUNCTIONS

    INTERNAL AUDITS:
       - Plan, conduct, and report on internal quality system audits.
       - Coordinate corrective actions and verify their effective implementation in response to audit findings.
       - Maintain and manage the internal audit schedule.

    EXTERNAL STANDARDS MANAGEMENT:
       - Track, analyze, and communicate changes to external standards that impact the medical device QMS.
       - Collaborate with cross-functional teams to ensure alignment with evolving standards.

    CAPA MANAGEMENT:
       - Own and manage the Corrective and Preventive Action (CAPA) process.
       - Support other CAPA owners in the identification of root causes, implementation of corrective actions, and verification of effectiveness.
       - Run periodic reports and analytics on open CAPAs to identify trends and areas of improvement.

    LABEL MANAGEMENT SUPPORT:
       - Serve as a backup for GS1 and GUDID label management processes.
       - Ensure labels are in compliance with relevant regulatory standards.

    REGULATORY GAP ASSESSMENTS:
       - Continuously assess the QMS against global medical device regulations.
       - Identify, report, and mitigate any gaps or non-conformities in the QMS related to global regulations.

    CONTINUOUS IMPROVEMENT:
       - Proactively identify opportunities for process and quality improvements.
       - Collaborate with cross-functional teams to implement enhancements to the QMS.

    QMS TRAINING MANAGEMENT:
       - Annual QMS training
       - Onboard/new employee QMS training
       - Electronic Signature for new employees
       - File ECO’s trainings as applicable

    SUPPORT DOCUMENT CONTROL:
       - Engineering Change Orders
       - Product Analysis/validations
       - Deviations
       - Filing other QMS documentation

    - Accept other responsibilities as assigned.
    - Complete training as identified by standard operating procedures and procedural work instructions.
    - Regular attendance is an essential job function.

    Follow all Company policies and procedures relating to confidential propriety information (CPI) including but not limited to what is outlined in the Confidentiality and Non-Solicitation Agreement.

    If this sounds like a good fit, please consider submitting your resume and cover letter in the form below.

  • Primary Purpose

    The Manufacturing Quality Engineer ensures the highest standards of quality and compliance.  The position is vital in overseeing the manufacturing processes to guarantee that all products meet regulatory requirements and company standards.  This position will collaborate closely with production teams and quality assurance personnel to develop, implement, and refine manufacturing quality control systems.

    KEY RESPONSIBILITIES AND ESSENTIAL FUNCTIONS

    NON-CONFORMANCE REPORT (NCR) AND INVESTIGATION:
       - Document and analyze NCR reports from Receiving/ Inspection and Production Departments
       - Perform containment and investigation actions related to non-conforming material/ products that escape production.
       - Prepare and communicate data analysis reports for monthly Product Performance and Quality Management Review meetings.

    ​​​​​​PRODUCTION ANALYSIS OF DATA:Production Analysis of Data:
       - Analyze in-process and final checkout yield data. 
       - Develop and provide reports and recommendations for monthly Product Performance and Quality Management Review meetings.

    CAPA
       - Ownership and execution of production and vendor related Corrective Actions/ SCARs
       - Identify and recommend preventative actions, including continuous product and process improvement.

    RISK MANAGEMENT:
       - Collaborate with Risk Management Team to develop and maintain PFMEAs.

    DESIGN ASSURANCE:​​​​​​​
       - Review and consult with Project Teams during the development process to ensure Company Design and Development procedures are followed through documentation audits and design reviews.

    ​​​​​​​AUDIT:​​​​​​​
       - Support the execution of quarterly UL Audit and Annual Surveillance/ Recertification assessments by Notified Body.
       - Assist QARA team with auditing of suppliers.

    - Accept other responsibilities as assigned.
    - Complete training as identified by standard operating procedures and procedural work instructions.
    - Regular attendance is an essential job function.
    - Follow all Company policies and procedures relating to confidential propriety information (CPI), including what is outlined in the Confidentiality and Non-Solicitation Agreement.

    Job Requirements

    Must Have – Minimum Requirements
       - Bachelor’s Degree in Technical, Scientific, or Engineering discipline
       - 5-7 years of experience in Quality Engineering, Design Assurance, or other Quality Systems role.
              -Experience in Medical Devices or other regulated industry preferred
       - Knowledge of ISO 13485, ISO 14971, IEC 60601, and other Medical Device related standards.
       - Process-oriented problem solver and strong documentation creation/ management experience.

    Nice to Have
       - Audit experience (both as auditee and auditor)
       - Lean/ Six Sigma certification

    Working Conditions or Physical Requirements

    - Will be required to regularly sit for extended periods of time; use hands and fingers, handle or feel objects, talk, hear and see.
    - Occasionally lift and/or move up to 25 pounds, stand, walk, climb, balance, stoop, kneel, crouch, or reach with hands and arms.
    - The environment is fast-paced; time pressured and requires accuracy.
    - Will be required to regularly multi-task between projects, move throughout the office building and effectively communicate.
    - The normal environment is quiet and typical of an open office setting with some areas that may be louder at times; along with time spent on the production floor, where environment can be louder due to equipment running.

    If this sounds like a good fit, please consider submitting your resume and cover letter in the form below.

  • Primary Purpose

    The Regulatory Affairs Analyst will ensure compliance to applicable quality and regulatory requirements.  This role manages support of vital regulatory tasks including complaint processing, post-market surveillance, and recall/ adverse event reporting.  The Analyst supports regulatory activities across pre- and post-market phases and conducts regulatory gap assessments to mitigate compliance risks.

    KEY RESPONSIBILITIES AND ESSENTIAL FUNCTIONS

    COMPLAINT PROCESSING:
       - Investigate and document customer complaints to identify quality issues and ensure compliance with applicable regulatory standards.
       - Collaborate with cross-functional teams to analyze root causes and implement corrective actions to prevent recurrence of issue

    POST MARKET SURVELLIANCE:
       - Monitor and analyze post-market data to assess the safety and effectiveness of medical devices throughout their lifecycle.
       - Prepare and review periodic reports on product performance, identifying trends that may require regulatory action or product improvements.

    RECALL/ADVERSE EVENT REPORTING:
       - Coordinate the timely reporting of adverse events and potential recalls to regulatory authorities, ensuring compliance with legal obligations.
       - Evaluate incident reports to determine the necessity for corrective actions and facilitate the execution of recall strategies, if required.

    PRE-MARKET REGULATORY SUPPORT:
       - Assist in preparing regulatory submissions for new products or changes to existing products, ensuring all necessary documentation meets regulatory standards.
       - Conduct thorough reviews of product labeling and marketing materials to guarantee compliance with regulatory requirements before market launch.

    POST-MARKET REGULATORY SUPPORT:
       - Provide ongoing regulatory advice and updates to ensure continued compliance of products with international standards and regulations post-launch.
       - Engage in continuous improvement initiatives by reviewing and updating regulatory strategies and documentation in response to evolving regulatory landscapes.

    REGULATORY GAP ASSESSMENTS:
       - Continuously assess the QMS against global medical device regulations, with a primary focus on the EU Medical Device Regulation (EU MDR).
       - Identify, report, and mitigate any gaps or non-conformities in the QMS related to global regulations.

    CONTINUOUS IMPROVEMENT:
       - Proactively identify opportunities for process and quality improvements.
       - Collaborate with cross-functional teams to implement enhancements to the QMS.

    - Accept other responsibilities as assigned.
    - Complete training as identified by standard operating procedures and procedural work instructions.
    - Regular attendance is an essential job function.
    - Follow all Company policies and procedures relating to confidential propriety information (CPI) including but not limited to what is outlined in the Confidentiality and Non-Solicitation Agreement.

    Job Requirements

    Must Have – Minimum Requirements
       - Bachelor’s Degree in Technical, Scientific, or Engineering discipline
       - 5-7 years of experience in Quality Assurance, Regulatory Affairs, or other Quality Systems role, preferably in medical device or other regulated industry.
       - Knowledge of ISO 13485, MDSAP, EU MDR, UK MDR and other global regulatory requirements.
       - Process-oriented problem solver and strong documentation creation/ management experience.

    Nice to Have
       - Audit Experience (both as auditee and/or auditor)

    Working Conditions or Physical Requirements

    - Will be required to regularly stand for extended periods of time; use hands and fingers, handle or feel objects, talk, hear, and see.
    - Occasionally lift and/or move up to 50 pounds, stand, walk, climb, balance, stoop, kneel, crouch, or reach with hands and arms. Requires repetitive motion and manual dexterity. 
    - The environment is fast paced; time pressured and requires accuracy.
    - Will be required to regularly multi-task between projects, move throughout the office building and effectively communicate.
    - The normal production environment can be louder due to equipment running.

    If this sounds like a good fit, please consider submitting your resume and cover letter in the form below.

  • Primary Purpose

    To provide accurate and timely financial analysis and reporting for US and international businesses, US parent company, and international holding company.

    KEY RESPONSIBILITIES AND ESSENTIAL FUNCTIONS

    - Provide financial analysis to internal customers and parent company.
    - Produce budget, forecasts, variance analyses, executive-level presentations.
    - Develop reports and dashboards to assist internal customer with driving the success of their department and the overall business.
    - Complete month-end consolidation of multiple international entities with US business.
    - Complete quarterly reporting for publicly traded international parent company.
    - Accept other responsibilities as assigned.
    - Complete training as identified by standard operating procedures and procedural work instructions.
    - Regular attendance is an essential job function.
    - Follow all Company policies and procedures relating to confidential proprietary information (CPI) including, but not limited to, what is outlined in the Confidentiality and Non-Solicitation Agreement.

    Job Requirements

    - BA/BS in Accounting, Finance, Economics or other business-related field
    - Analytics, budgeting, and forecasting experience
    - Advanced Excel and BI tool skills
    - Demonstrated ability to build and deliver effective presentations to audiences with wide-ranging backgrounds
    - Attentive, ability to work independently and prioritize tasks
    - Outstanding analytical, quantitative and social skills
    - Self-driven motivator who takes initiative on projects with a strong ability to understand and solve creative challenges
    - Ability to prioritize work and balance multiple projects and deadlines
    - Foundational knowledge in IFRS a plus
    - Prior experience in a manufacturing business a plus
    - Previous experience in public accounting is highly valued
    - Demonstrated ability to work in a dynamic and constantly changing company environment
    - Ability to work within a multi-national corporate environment with overseas subsidiaries
    - Ability to effectively communicate in English. Excellent written and verbal communications skills and interpersonal skills.
    - Strong problem solving and troubleshooting skills.

    Working Conditions or Physical Requirements

    - Will be required to regularly sit for extended periods of time; use hands and fingers, handle or feel objects, talk, hear, and see. The environment is fast paced; time pressured and requires accuracy. Will be required to regularly multi-task between projects, move throughout the office building and effectively communicate. The normal environment is quiet and typical of an open office setting with some areas that may be louder at times; along with time spent on the production floor, where the environment can be louder due to equipment running.
    - Currently Finance is operating on a hybrid working model with time working remotely as well as in the St Paul office.
    - Some travel may be involved, both domestic and international.

    If this sounds like a good fit, please consider submitting your resume and cover letter in the form below.

  • Primary Purpose

    Responsibilities will include product assembly, testing of sub-assemblies and final system checkout for all products, both pulmonary function and gas exchange. Develop, implement, and maintain manufacturing procedures which support quality objectives and build schedule objectives. Ensure continuity of quality processes in the manufacture of MGC products.

    KEY RESPONSIBILITIES AND ESSENTIAL FUNCTIONS

    - Support team in manufacturing of sub-assembly, final assembly, and testing of all MGC products as requested.
    - Perform QC system checkouts on MGC products as required.
    - Read Schematics and use electronic test equipment to troubleshoot sub and final assemblies.
    - Ensure that GMP compliance is met at all stages of production.
    - Monitor WIP to ensure:
           - Work order shortages are minimized, confer status with Production Manager
           - WIP and stock inventories are accurate.
           - Work is available for team members when they will need it.
    - Perform manufacturing training including:
           - Soldering
           - Crimping
           - Sealants and thread lockers
           - ESD practices and standards
    - Aid in the writing and implementation of ECOs and deviations
    - Maintain a clean and safe work area.
    - Accept other responsibilities as assigned.
    - Complete training as identified by standard operating procedures and procedural work instructions.
    - Regular attendance is an essential job function.
    - Follow all Company policies and procedures relating to confidential proprietary information (CPI) including, but not limited to, what is outlined in the Confidentiality and Non-Solicitation Agreement.

    Job Specifications:

    - Minimum 2-year electronics degree or equivalent
    - Bachelor of Science in Electrical Engineering preferred, with experience of manufacturing and testing on equipment.
    - Be able to respond purposefully and handle stress in all circumstances.
    - Proficiency with the MRP database to perform the following:
           - Find part numbers and stock locations.
           - Transaction History
           - MRP Details
           - Review Shortages
           - Inventory control
           - Post operation completion
    - Be an independent self-starter with attention to detail.
    - Proven ability to meet deadlines and set goals.
    - Have sufficient skill and proficiency to train employees in the following areas:
           - Soldering practices / standards
           - Thread sealant / locker practices / standards
           - ESD practices / standards
           - All MGC product checkouts and assembly.
    - Ability to accurately read schematics.
    - Proficiency in use of test equipment.
    - Ability to effectively communicate in English. Excellent written and verbal communications skills and interpersonal skills.
    - Strong problem solving and troubleshooting skills.

    Working Conditions or Physical Requirements

    - Will be required to regularly sit for extended periods of time; use hands and fingers, handle or feel objects, talk, hear, and see. Occasionally lift and/or move up to 50 pounds, stand, walk, climb, balance, stoop, kneel, crouch, or reach with hands and arms. The environment is fast paced; time pressured and requires accuracy. Will be required to regularly multi-task between projects, move throughout the office building and effectively communicate. The normal environment is typical of an operations environment with areas that can be louder due to equipment running.
    - Some overtime required.
    - Maintain a clean work environment.

    If this sounds like a good fit, please consider submitting your resume and cover letter in the form below.

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