The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures. The Design Assurance Engineer will ensure a successful transfer of newly developed product to production, while supporting design phases concept through launch.
Key Accountabilities and Responsibilities
1. Adheres to GB Core Beliefs and all safety and quality requirements.
2. As a quality Core Team member actively participates in development project teams. Performs quality/reliability engineering activities while providing guidance to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled
3. Leads Risk Management (ISO 14971) and Usability program activities. Leads cross function teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Prepares required deliverables to execute and document the risk management outcomes, controls measures, residual risks in reports. Maintains risk management file for the life of the device.
4. Coordinates with R&D in DAE review of technical documentation, develop test methods and prepare design verification and validation test deliverables. Plans and conducts compliance testing to recognized international standards.
5. Coordinates with Advanced Manufacturing Engineering in development of test fixtures/ test methodology, develop production acceptance criteria, test methods, and process validation protocols.
6. Provides support in supplier and internal auditing (DHF and Technical files for conformance), external lab qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.
7. Provides support in conducting root cause analyses, preparation of CAPA and HHA. Draft and update SOPs
8. Performs other functions as required.
Minimum Education: Bachelor's degree in Mechanical Engineering or Electrical Engineering, or equivalent. Minimum Experience: 5-7 years in medical device manufacturing and design environment.
- Practical knowledge of FDA Quality System Regulations, ISO 13485 and Medical Device Directive.
- Practical knowledge of ISO 14971, ISO 62366, IEC 60601-1 and related standards
- General familiarity with industry best practices in electrical, mechanical, SW development, testing and manufacturing processes. Medical device sterilization process
- Experience in interpreting electrical design schematics and mechanical design drawings.
- Preferred experience with FDA Class II, IIb and III mechanical and electromechanical medical devices
- Skilled in statistical methods e.g. ANOVA, SPC, test sample size g plans, Gauge R&R, and DOE.
- Demonstrated proficiency utilizing quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe).
- Experience establishing and implementing quality metrics for product development. Special Skills: Strong collaboration, negotiation, and conflict resolution skills.
- Excellent verbal and written communication skills.
- ASQ CQE (Certified Quality Engineer) preferred.
Other: Up to 10% travel.