Design Assurance Engineer
Sorry, this particular job is closed. But feel free to fill out a General ApplicationSearch Jobs
Design Assurance Engineer
Title:Design Assurance Engineer
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.
- Adheres to 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. Builds consensus where appropriate.
- Leads Risk Management (ISO 14971) activities. May leads cross functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the life of the device.
- Generates and/or reviews related project deliverables such as: design verification and design validation protocols and reports as well as process validation protocols and reports. Coordinates with R&D in the review of technical documentation.
- Works with Product Development Manufacturing Engineering in the development of test fixtures, develop production acceptance criteria and test methodology.
- Coordinates sourced item qualification activities and supports supplier risk management initiatives. Conducts Independent review of DHF and Technical files, provides technical standards interpretation, and determines appropriate statistical methods, including sample size determination.
- Provides support in conducting root cause analyses, preparation of CAPA and Distributed Product Risk Assessment. Draft and update SOPs as required.
- Minimum Education: Bachelor's Degree in Engineering or related field required. Master's Degree preferred.
- Minimum Experience: 5-7 years of experience.
- Specialized Knowledge:
- Practical knowledge of FDA Quality System Regulations, ISO 13485 and Medical
- Device Directive.
- Practical knowledge of ISO 14971, and related standards
- General familiarity with industry best practices in development, testing and manufacturing processes.
- Experience in interpreting design schematics and drawings.
- Preferred experience with FDA and European regulated medical devices
- Skilled in statistical methods e.g. ANOVA, SPC, test sample size selection plans, Gauge R&R, and DOE.
- Demonstrated proficiency utilizing quality lean sigma tools (e.g. Root Cause
- Analysis, QFD, Ishikawa, Kepner-Tregoe).
- Experience in establishing and implementing quality metrics for product development.
- Maintenance Multi-Craft Day Shift in Gainesville GA
- Maintenance Technician in Lawrenceville GA
- Customer Service Rep in Needham Heights MA
- Receptionist in Alpharetta GA
- Outside Account Manager in Brooklyn Park MN
- NDT Level III Inspector in Santa Fe Springs CA
- NDT Level II Inspector in Santa Fe Springs CA
- Quality Control Inspector in Cumming GA
- Assembler - Kitter in Milford MA
- Mechanical Drafter in Brooklyn Park MN
- Solidworks Drafter in McBee SC
- IT Recruiter MA in Woburn MA
- Electrical Engineer in Alpharetta GA
- Manufacturing Engineer in Pendergrass GA
- 2nd Shift Machine Operator in Newton MA
- Collections Specialist in Norwell MA
- Financial Analyst in Milford MA
- Inventory Controller in Lebanon NH
- Shipper in Plymouth MA
- Sr. Assembly Technician in East Boston MA
- CAD designer in Hudson MA
- Welder in Duluth GA
- Safety Engineer in Norcross GA
- Material Handler in Taunton MA
- Manufacturing Supply Chain Clerk in Doraville GA
- Shipping in Duluth GA
- Mechanical Packaging Engineer in Ayer MA
- Shipping & Receiving Clerk in Norwood MA
- Manufacturing Lab Technician in Norwood MA
- Maintenance Planner in Gainesville GA
- Engineering Intern in Memphis TN
- Order Processor in Duluth GA
- Planner in Duluth GA
- Depot Repair Technician in Duluth GA
- Receiving Material Handler in Flowery Branch GA
- Warehouse in Suwanee GA
- Deployment Team in Suwanee GA
- Assembler in Acton MA
- Technical Recruiter MA in Marlborough MA
- QA Technician in Lawrence MA
- ID-OD GRIND MACHINIST in Santa Fe Springs CA
- Electromechanical Technician in Beverly MA
- Controls Engineer in Vance AL
- Electrical Design Engineer in Suwanee GA
- Wiring Technician in Suwanee GA
- Mechanical Design Engineer in Suwanee GA
- HR Director in MA
- CNC Machinist in Contoocook NH
- Sr. Electrical Designer in Alpharetta GA
- Quality Engineer in Minneapolis MN
- 2nd Shift Machine Operator in Plymouth MA
- 2nd shift ID-OD GRIND MACHINIST in Central Manchester CT
- Shipper- Warehouse Associate (seasonal) in Ashland MA
- Control Panel Power Wirer in Brooklyn Park MN
- Maintenance Controls Tech in Gainesville GA
- Electro-Mechanical Assembler - Technician in New Brighton MN
- Buyer in Milford NH
- Shipping Clerk in Brooklyn Park MN
- Bench Repair Technician in Cumming GA
- Welder - Sheet metal fabricator in N. Billerica MA
- Program Manager in Saint Petersburg FL
- electro-mechanical assemblers in Merrimack NH
- Standard Fabrication - 1st Shift in Suwanee GA
- Quality Engineer in Newnan GA
- Maintenance Mechanic in Lynn MA
- EM Assembler in Westborough MA
- Manufacturing Engineer in Chelmsford MA
- Quality Engineer in Maple Grove MN
- Packaging Supervisor in Lynn MA
- Technical Writer in Norwell MA
- Accountant in Loganville GA
- Assembly in Buford GA
- Wiring Technician in Buford GA
- Production Admin in Duluth GA
- Shift Supervisor in Duluth GA
- Maintenance Mechanic, Class A, 1st shift in Worcester MA
- Industrial Engineer in Loganville GA
- 2nd Shift Shipping Lead in Lynn MA
- Quality Engineer in Clinton MA
- Assembly Technician in Tucker GA
- Assembler in Suwanee GA
- Press Brake Operator in Duluth GA
- Mechanical Engineer in Bedford MA
- Process Engineer in Covington GA
- Refrigeration Technician in Acton MA
- Electrical Technician in Milford MA
- Supplier Quality Technican in Milford MA
- Documentation Control Specialist in Maple Grove MN
- Clinical Data Manager in Boston MA
- Mechanical Assembler- 2nd Shift in Santa Fe Springs CA
- machinists- 2nd shift 3p-11 in Santa Fe Springs CA
- Programmer in Contoocook NH
- Quality Documentation Coordinator in Bloomington MN
- Lab Processing Clerk in Norwood MA
- Sr. Mechanical Engineer in Norwood MA
- Inside Sales Representative in Golden CO
- Microdeburrer in Milford MA
- Assembly Specialist in Milford MA
- Quality Assurance Technician in Maple Grove MN
- Lean Manager-Continuous Improvement Manager in Milford NH