[Hiring] Principal Design Quality Engineer @Haemonetics

Role Description

Principal Design Quality Engineer will provide leadership in the design and implementation of world-class quality engineering to support activities such as:

• Reliability
• Risk management
• Analytics/statistical techniques
• Requirements management
• Verification and validation
• Design control

Activities would drive prevention, detection of defects at the earliest phase of product design, continuous improvement and customer satisfaction.

Qualifications

• BS in Engineering in Electrical, Biomedical, Mechanical, or other equivalent technical engineering discipline required (Advanced degree, Masters or PhD, substitute 2 years experience below)
• 8 years in a medical device or equivalent regulated environment
• 8 years Design Quality Engineering or equivalent design experience required
• Professional certification as one or more of the following:
  • Certified Quality Engineer
  • Certified Reliability Engineer
  • Certified Six Sigma Black Belt

Requirements

• Provide Quality leadership for new product development and product change management
• Ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems
• Support global product registration needs by acting as the liaison for technical questions as it pertains to design control and compliance to external standards
• Provide leadership & support to process excellence initiatives including Six-sigma, design excellence & lean thinking
• Represent Quality department as a cross-functional team member for product portfolios, new product development projects, and product change projects
• Manage project quality plans
• Lead or participate in the translation of Voice-of-Customer into development Requirements
• Support the development team in the creation, review, and approval of engineering Requirements & Specifications in accordance with standard operating procedures
• Lead cross-functional teams in the development, update, and release of risk management documentation inclusive of but not limited to: Hazard Analysis, Risk Management Plan & Report, FMEA’s (Use, Design & Process), Fault Tree Analysis (FTA)
• Lead or support the development team in the creation, review, and approval of engineering development plans & test plans
• Support the development team in the creation, review, and approval of engineering test protocols and reports in support of design verification, design validation, and process validation
• Lead the development team in creation, review, and approval of critical-to-quality specifications
• Support development team in the creation, review, and approval of traceability of user requirements, engineering specifications, and verification & validation testing
• Lead measurement systems analysis for acceptability and develop, support, & approve validation protocols and reports for test methods
• Define statistical testing methods and sampling in support of verification and validation testing
• Ability to support any Product Line Portfolios and actively support 1 or more Product Line Portfolios
• Ensure accuracy and completeness of the Design History File and the Device Master Record
• Compile, review, and analyze failure data to provide feedback to the development team
• Mentor, develop, coach, and/or supervise less experienced quality engineers

Benefits

• Competitive pay range: $103,600.00-$176,400.00/Annual
• 401(k) with up to a 6% employer match and no vesting period
• Employee stock purchase plan
• Flexible time off for salaried employees
• Accrual of three to five weeks’ vacation annually (based on tenure) for hourly employees
• Accrual of up to 64 hours (annually) of paid sick time
• Paid and/or floating holidays
• Parental leave
• Short- and long-term disability insurance
• Tuition reimbursement
• Health and welfare benefits