Last - und Performancetester coordinating and executing performance tests for applications at Deutsche WertpapierService Bank AG. Collaborating with teams and ensuring software quality across systems.
About the role
- Senior Software Quality Engineer leading software quality efforts for Affera cardiac systems. Collaborating with engineering and regulatory teams to ensure compliance and drive patient outcomes.
Responsibilities
- 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)
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Quality hands - on support and expertise in supplier quality and modernizations. Liaison between operations, suppliers, and customers to ensure quality standards and expectations are met.
Quality Assurance Specialist ensuring quality of equipment installation on project sites for Andritz Canada. Focused on maintaining high quality standards and client coordination in construction environments.
Quality Engineer intern coordinating quality activities at Arquus in Limoges. Joining a highly qualified team in the development and manufacturing of all - terrain armored vehicles.
Quality Assurance & Regulatory Affairs Specialist supporting Demant's 3rd - party business partners. Handling documentation, audits, and regulatory coordination within an international organization.
Senior Quality Engineer working in a dynamic environment with a focus on product quality for hearing impaired. Opportunities for professional growth and exciting projects.
QA Tester validating software quality at innovative technology company. Designing and executing test strategies while collaborating with international teams in a dynamic environment.
Senior Frontend Entwickler und QA - Engineer in der Softwareentwicklung bei Creditreform. Verantwortlich für die Entwicklung von Web - Frontends und Gewährleistung hoher Softwarequalität in Neuss.
Software Testautomatisierer developing and maintaining automated test solutions in hybrid working conditions at medium - sized IT firm Mentopolis Consulting & Software Concepts GmbH.
Design Quality Assurance Engineer responsible for managing product design and compliance in medical technology industry. Collaborating across departments to meet regulatory standards and improve quality processes.