Principal Design Quality Engineer
Haemonetics
Summary
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, and design control. Activities would drive prevention, detection of defects at the earliest phase of product design, continuous improvement and customer satisfaction.
Job description
Job Summary
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, and design control. Activities would drive prevention, detection of defects at the earliest phase of product design, continuous improvement and customer satisfaction.
Responsibilities
- Provide Quality leadership for new product development and product change management
- Provide leadership and technical expertise to ensure conformance to ISO, FDA and MDD based quality systems
- Support global product registration needs as liaison for technical questions on design control and compliance to external standards
- Provide leadership and support to process excellence initiatives including Six-sigma, design excellence and 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
- Lead cross-functional teams in the development, update, and release of risk management documentation including Hazard Analysis, Risk Management Plan & Report, FMEAs (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 for design verification, design validation, and process validation
- Lead the development team in creation, review, and approval of critical-to-quality specifications
- Support traceability of user requirements, engineering specifications, and verification & validation testing
- Lead measurement systems analysis for acceptability and develop, support, and approve validation protocols and reports for test methods
- Define statistical testing methods and sampling in support of verification and validation testing
- 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
- Support and administer quality system elements including Design Controls, CAPA, Non-Conformance, Complaint, Deviation, Document Controls, Labeling
- Lead continuous improvement projects and reviews of policies, procedures, instructions, and training
- Ensure ongoing readiness for and participate in internal/external audits and inspections
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
- BS in Engineering in Electrical, Biomedical, Mechanical, or other equivalent technical engineering discipline
- 8 years in a medical device or equivalent regulated environment
- 8 years Design Quality Engineering or equivalent design experience
- Professional certification as Certified Quality Engineer, Certified Reliability Engineer, or Certified Six Sigma Black Belt
- Must be legally authorized to work in the United States
Benefits
- 401(k) Matching
- Employee Stock Purchase Plan
- Flexible Time Off
- Paid Sick Time
- Paid Holidays
- Parental Leave
- Short-Term Disability Insurance
- Long-Term Disability Insurance
- Tuition Reimbursement
- Health and Welfare Benefits
Company overview
Haemonetics Corporation is a global leader in blood and plasma management solutions, founded in 1971 and headquartered in Boston, Massachusetts. As a publicly traded company listed on the NYSE under the symbol HAE, Haemonetics specializes in developing and manufacturing medical devices and systems for blood component collection, processing, and transfusion management. The company operates across three primary segments: plasma collection, blood center operations, and hospital transfusion services. Haemonetics' innovative product portfolio includes automated blood collection systems, surgical blood salvage devices, hemostasis management systems, and temperature regulation equipment for medical applications. With approximately 3,300 employees worldwide and operations in 16 countries, the company generates annual revenues exceeding $1.3 billion. Haemonetics has established itself as a critical partner to healthcare providers by offering comprehensive solutions that enhance patient safety, improve clinical outcomes, and optimize blood management workflows across the continuum of care.