The primary purpose of this position is to support new product development activities to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and the Company's Policies & Procedures. The Design Assurance Engineer will ensure a successful transfer of newly developed product to production, while supporting design concept phases through launch.
Integer's Cardiac Rhythm Management & Neuromodulation product category is hiring for a Design Assurance Engineer II at our Plymouth, MN facility.
Key Accountabilities and Responsibilities
- Adheres to Integer values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
- As a quality Core Team member, actively participates in development project teams. Performs quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled.
- Generates and/or reviews related project deliverables, such as design verification and design validation protocols and reports; and process validation protocols and reports.
- Participates in risk assessment and mitigation activities (FMEA, FTA, etc.) in support of new product development.
- Supports Product Development Manufacturing Engineering in development of test fixtures/ test methodology, develop production acceptance criteria and test methods.
- Coordinates the preparation of Quality Plans, including inspection and gauge requirements.
- Provides support for root cause analyses, CAPA and Distributed Product Risk Assessment and updates SOPs as required.
- Coordinates sourced item qualification activities and supports supplier risk management initiatives.
- Performs other functions as required.
- Minimum Education: Bachelor's Degree in Engineering or related field
- Minimum Experience: 2-5-year(s) experience
- Experience with statistical software packages such as Minitab.
- Demonstrated problem solving skills.
- Knowledge of ISO and FDA quality, process validation and system requirements
- Experience in interpreting design schematics and drawings
- Skilled in statistical methods e.g. ANOVA, SPC, sample size determination, Gauge R&R and DOE.
- Knowledge of quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe).
- Strong written and oral communication skills, including technical writing. Demonstrated ability to work in a team environment.