Principal Design Quality Engineer

Job not on LinkedIn

🔥 15 hours ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

💵 $103.6k - $176.4k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Haemonetics

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1980

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Haemonetics is a company that provides a suite of innovative medical technology solutions aimed at improving the quality, effectiveness, and efficiency of healthcare. The company focuses on optimizing operations for plasma centers, enhancing patient care in hospitals, and driving efficiency in blood centers by offering advanced technologies that improve productivity, quality, and safety. Haemonetics is committed to advancing healthcare standards and creating better outcomes for patients through their technology and services.

📋 Description

• Provide leadership in design and implementation of quality engineering for reliability, risk management, analytics/statistical techniques, requirements management, verification and validation, and design control • Lead quality activities for new product development and product change management • Ensure conformance to ISO, FDA, and MDD-based quality systems • Support global product registration by serving as liaison for technical design-control and external-standards questions • Support Six Sigma, design excellence, and lean-thinking process-excellence initiatives • Represent Quality on cross-functional product portfolio, new product development, and product change teams • Manage project quality plans • Translate Voice-of-Customer into development requirements • Support creation, review, and approval of engineering requirements, specifications, development plans, test plans, test protocols, and reports • Lead cross-functional development and approval of risk management documentation, including Hazard Analysis, Risk Management Plans and Reports, FMEAs, and FTA • Lead development of critical-to-quality specifications • Support traceability of user requirements, engineering specifications, and verification and validation testing • Lead measurement systems analysis and support or approve validation protocols and reports for test methods • Define statistical testing methods and sampling for verification and validation testing • Support one or more Product Line Portfolios • Ensure accuracy and completeness of the Design History File and Device Master Record • Compile, review, and analyze failure data and provide feedback to development teams • Mentor, develop, coach, and/or supervise less experienced quality engineers • Ensure compliance with regulations, standards, policies, procedures, and instructions • Support quality system elements including Design Controls, CAPA, Non-Conformance, Complaint, Deviation, Document Controls, and Labeling • Lead continuous improvement projects and reviews of policies, procedures, instructions, and training • Ensure audit and inspection readiness and participate in internal and external audits and inspections

🎯 Requirements

• BS in Engineering in Electrical, Biomedical, Mechanical, or another equivalent technical engineering discipline required • Advanced degree, Masters or PhD, may substitute for 2 years of experience • 8 years in a medical device or equivalent regulated environment • 8 years of 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 • Applicants must be legally authorized to work in the United States • Haemonetics will not provide employment visa sponsorship for this position

🏖️ Benefits

• Discretionary annual bonus for non-sales roles • Eligibility for the company’s long-term incentive plan, depending on role • 401(k) with up to a 6% employer match and no vesting period • Employee stock purchase plan • Flexible time off for salaried employees • Three to five weeks’ vacation annually for hourly employees, based on tenure • 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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