Lead Design Quality Engineer

Role Summary

We are looking for an experienced and motivated Lead Design Quality Assurance Engineer to join our Quality Assurance team. This role will provide pre-market and post-market Design Quality Engineering support to ensure delivery of highest quality products to the customer.

What You’ll Do

• Support the New Product Development process; work with the Design History File (DHF) and Device Master Record (DMR) and ensure that design projects comply with internal design control procedures.
• Apply knowledge of Design Control and Quality Engineering principles to positively influence new product development efforts, including those for Voice of the Customer, establishing design inputs/outputs, Design Verification & Validation, Process Qualification & Validation, and Risk Management.
• Work with Assay Development, Instrument engineering, Operations, Service and other teams as needed to support vendor qualification, software validation, instrument IQ/OQ/PQ and assay system validation.
• Assess post launch purpose design changes to determine impact on risk level, verification and/or validation testing.
• Maintain Risk Management Files in compliance with regulatory requirements and local procedures.
• Provide guidance on external compliance requirements such as Safety, EMC, RoHS, China RoHS, WEEE, Cybersecurity and represent the QA function at Design Reviews.
• Mentor peers, project team members and lower-level Quality Engineers in the application of risk management and design control requirements and industry best practices.
• Support a wide range of continuous and process improvement initiatives, including remediation efforts, product development, and sustaining projects.
• Support other quality and compliance activities as required including supporting regulatory submissions, internal audits and inspections.
• Help to drive and foster a quality environment and mindset throughout the business.
• Support special projects as needed.

BASIC QUALIFICATIONS

• 5+ years’ experience in a Quality function within the Medical Device, Biotechnology, Life Sciences or similar discipline arena desired.
• Minimum of a Bachelor’s Degree required in related field (Biomedical, Software, Electrical, Mechanical Engineering or equivalent), Advanced degree is a plus (M.S. in a Life Science, or equivalent).
• In-vitro diagnostic manufacturing or contract mfg environment (instrumentation/software and reagents) experience.

PREFERRED QUALIFICATIONS

• Thorough understanding of GMP/ISO regulations (ISO 14971, ISO 13485, EN61010, IEC 62304, IVDR and 21CFR820).
• Able to work independently, with minimal daily guidance.
• Excellent cross-functional team participation skills.
• Highly organized and detail oriented.
• Proficiency with standard business tools: word processing, presentations, spreadsheets, manufacturing software, database software.
• Strong work ethic and organizational skills to manage multiple projects under tight deadlines with a collaborative attitude is a must.

Expectations, Competencies, Skills & Abilities

• Demonstrates a strong quality mindset with the ability to align quality engineering activities to product performance, customer needs, and business objectives.
• Applies critical thinking and sound judgment to assess design changes, identify risks, and recommend practical, compliant solutions.
• Buils effective cross-functional partnerships and influences stakeholders at all levels to drive quality and compliance objectives.
• Communicates clearly and effectively, translating complex quality and regulatory concepts for both technical and non-technical audiences.
• Solves problems proactively using structured root cause analysis and data-driven decision-making to support continuous improvement.
• Provides leadership, guidance, and mentoring to peers and project teams in the application of design control, risk management, and quality best practices.
• Adapts effectively in a dynamic environment, balancing shifting priorities, evolving requirements, and multiple project demands.
• Demonstrates strong execution, organization, and follow-through to ensure timely delivery of high-quality work and project outcomes.
• Experience using eQMS tools; Mastercontrol, Arena, TrackWise, etc.

Pay Range

$125,000 - $150,000 per year