PG
Proway GmbHJunior Quality Engineer
Junior Quality Engineer collaborating in project teams to maintain compliance with quality standards and regulations. Involving product validation and certification at a well - established IT company.
About the role
- Support software quality and reliability efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485.
- Serve as member of the extended quality team for Affera software releases used for mapping and navigation in electrophysiology procedures.
- Collaborate with other quality team members to take accountability for completing assigned functional work within program deadlines.
- Review and approve various Design History File documents related to software and security, including requirements, design, development, integration, test protocols, test reports, verification, validation, and tooling.
- Ensure all documentation meets reliability standards and follows QMS processes.
- Develop and review documentation for traceability, testability, and compliance according to standard operating procedures.
- Develop expertise in assigned products and projects, including hands-on time in the engineering lab and participation in product training as assigned.
- Participate in software risk analysis and defect assessments as assigned.
- Contribute to tracking software quality metrics for assigned programs, supporting continuous monitoring and improvement of quality outcomes to achieve required levels of product reliability.
- Provide software quality support for post-market activities and analysis, including work supporting issue assessments, health risk assessments, and CAPAs.
- Recommend design or test methods to achieve appropriate levels of product reliability and security.
- Propose changes to design or testing as necessary to improve software and/or process reliability.
- Contribute to reliability engineering program strategies to achieve Medtronic, customer, and regulatory reliability objectives for assigned programs.
- Review and support strategies for product security testing as assigned.
- Attend a live EP case at least once per year to enhance workflow and product knowledge.
- Regularly participate in virtual live case learning opportunities.
- Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements.
Requirements
- Bachelor's degree and a minimum of 4 years of relevant experience OR Master’s degree with a minimum of 2 years of relevant experience OR PhD with 0 years relevant experience
- At least 1 year of experience supporting product development.
- Ability to perform simple coding tasks and effectively read, interpret, and understand existing software code.
- 2+ years of medical device or other regulated industry (such as defense or aerospace) experience.
- 2+ years of industry experience working with a software development team.
- Experience creating risk analysis documentation such as FMEAs and FTAs.
- Experience using or working with products built on Python, Qt, Docker, and Linux.
- Strong knowledge of cybersecurity and the software lifecycle within regulated environments, including design, development, and post-market support.
- Experience with cardiac and electrophysiology medical specialties.
- Advanced degree in a relevant field.
- Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ, or similar).
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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