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Design Quality Assurance Engineer
2 weeks ago
- The Design Assurance Engineer will interface with R&D and other supporting cross-functional teams on developing and maintaining medical equipment, including software and cybersecurity elements.
- Design assurance drives the ISO 14971 risk management process, Verification & Validation (V&V) process.
- This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems/procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports.
- Interfaces with all other quality and engineering components within the company and with customers and suppliers on quality-related issues.
- Actively participate in all aspects of Design Control, including capital equipment, systems, and software. Serves as a quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals and priorities.
Key Responsibilities:
- Support the execution and documentation of Design Validation & Verification and Usability activities.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
- Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications).
- Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
- Lead and support cross-functional root-cause analysis investigation and resolution activities
- Evaluate and support design test and inspection method development, and lead method validation activities
- Support regulatory submissions to notified bodies.
- Understanding of technologies incorporated into design.
- Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering or Electrical Engineering.
- 2+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
- Problem solver, capable of facilitating the problem-solving process
- Adaptable and effective collaborator in a team environment and in self-directed work
- Strong communication skills (verbal & written)
- Ability to work in a highly matrixed and geographically diverse business environment
- Demonstrated use of Quality tools/methodologies
- Previous Software or Capital equipment Design Assurance experience is a plus
- Medical device or other regulated industry experience
- Strong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO and software standards (IEC 62304 or IEC 82304)
- Experience with 60601, software and cybersecurity
- Experience working in an Agile environment
