Senior Design Quality Engineer
Location
United States
Posted
8 days ago
Salary
$140.6K - $150K / year
Seniority
Senior
No structured requirement data.
Job Description
Senior Design Quality Engineer
Haemonetics
Role Description Ensure compliance with applicable regulations, standards, corporate policies, and procedures related to design controls, product development, and engineering change management within the quality system. - Serve as the Quality representative on cross-functional teams for new product development, product design changes, and product line portfolio initiatives. - Develop, manage, and execute project-specific Quality Plans. - Lead or contribute to the translation of Voice-of-Customer (VoC) feedback into measurable engineering requirements. - Support the drafting, review, and approval of engineering requirements and specifications in compliance with standard operating procedures. - Lead cross-functional risk management efforts, including development and maintenance of risk documentation such as: - Hazard Analyses - Risk Management Plans and Reports - Use/Design/Process FMEAs - Fault Tree Analyses (FTA) - Support or lead the development and review of design verification, validation, and process validation plans, protocols, and reports. - Lead the identification and documentation of critical-to-quality (CTQ) characteristics and specifications. - Ensure full traceability between user needs, system requirements, and verification/validation activities. - Perform or support Measurement Systems Analyses (MSA), including the development and validation of test methods. - Define statistical sampling plans and test methodologies for verification and validation activities. - Contribute to multiple product portfolios; provide subject-matter expertise across various product lines as needed. - Maintain and ensure completeness of the Design History File (DHF) and Device Master Record (DMR). - Analyze product failure data and provide actionable insights and recommendations to development teams. - Mentor, coach, and/or train junior quality engineering staff. - Administer and support Quality System elements including: - Design Controls - CAPA - Non-Conformance - Complaints - Deviations - Document Control - Labeling - Lead or participate in quality system improvement initiatives, including updates to policies, procedures, work instructions, and training materials. - Ensure inspection and audit readiness; support internal and external audits by regulatory bodies and customers. - Lead or contribute to structured problem-solving and continuous improvement projects. Qualifications - Bachelor’s degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering or related field (or foreign degree equivalent) and at least 5 years of experience with Design Quality Engineering within a medical device or other regulated environment. - Employer will also accept a Master’s degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering or related field (or foreign degree equivalent) and 2 years of experience with Design Quality Engineering within a medical device or other regulated environment. Requirements - At least 2 years of experience with medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485). - At least 2 years of experience managing cross-functional projects. - At least 2 years of experience in technical writing, including authoring requirements and specifications. - At least 2 years of experience with Voice-of-Customer development and translation into engineering requirements. - At least 2 years of experience performing risk analysis, including FMEA and FTA. - At least 2 years of experience with measurement systems, applied statistics, reliability testing, and continuous improvement methodologies. - At least 2 years of experience mentoring or training junior team members. - At least 2 years of experience working with medical products, including blood collection systems, apheresis devices, or hemostasis management software. Benefits - Competitive salary: $140,587 – $150,000/year. - 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.
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