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.
Integer's Cardio & Vascular product category is hiring for a Sr. Design Assurance Engineer at our Chaska, MN facility. Below are details on this exciting opportunity.
Key Accountabilities and Responsibilities
- Adheres to Integer Core Beliefs and all safety and quality requirements.
- 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
- 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.
- 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.
- Coordinates with Advanced Manufacturing Engineering in development of test fixtures/ test methodology, develop production acceptance criteria, test methods, and process validation protocols.
- 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.
- Provides support in conducting root cause analyses, preparation of CAPA and HHA. Draft and update SOPs
- Performs other functions as required.
- Bachelor's degree in Mechanical Engineering or Electrical Engineering, or equivalent.
- 5-7 years in medical device manufacturing and design environment.
- Specialized Knowledge:
- 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 electro-mechanical 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.
- Strong collaboration, negotiation, and conflict resolution skills.
- Excellent verbal and written communication skills.
- ASQ CQE (Certified Quality Engineer) preferred.