JOB DESCRIPTION
Pay Range: $105,000.00 - $125,000.00 / year
Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.
The Staff Design Quality Engineer is a highly experienced technical quality leader responsible for quality oversight of complex IVD medical device development programs, high-risk changes, and technically demanding validation and design transfer activities.
This role applies advanced judgment to product quality, risk, and compliance decisions and serves as a senior subject matter expert for design controls, risk management, validation strategy, design changes, and development documentation.
The role routinely influences program direction, mentors others, and helps resolve the most difficult technical quality issues.
JOB RESPONSIBILITIES
- Serve as a senior design quality subject matter expert for complex IVD product development and lifecycle programs involving significant technical, regulatory, or cross-functional complexity.
- Provide authoritative review and approval of key design control deliverables, including design and development plans, requirements, risk files, validation strategies, design reviews, traceability matrices, and transfer packages within delegated authority.
- Guide cross-functional teams in translating customer, user, clinical, laboratory, manufacturing, and regulatory requirements into complete and verifiable design inputs and robust design outputs.
- Lead quality evaluation of major design changes, platform expansions, assay updates, labeling or usability changes, and transfer activities, ensuring impacts are fully assessed and documented.
- Provide senior-level quality oversight of analytical and clinical validation programs, including review of scientific rationale, protocol quality, deviation investigations, data review approach, and final evidence package sufficiency.
- Lead or advise on complex investigations, CAPAs, nonconformance assessments, and risk-based decisions involving technical uncertainty or product safety/performance concerns.
- Drive improvement of design quality processes, templates, training content, and governance mechanisms to strengthen consistency, traceability, and inspectionreadiness.
- Represent Design Quality during internal audits, regulatory inspections, partner/customer interactions, and design review governance forums.
- Mentor design quality and development personnel and provide expert consultation to management on difficult technical quality matters.
- Support management review by elevating systemic quality risks, adverse trends, and opportunities for improvement across the development portfolio.
JOB QUALIFICATIONS
Required WorkExperience:
- 8+ years of progressive experience in design quality, development quality, or quality engineering within medical device or IVD environments.
- Deep technical acumen in design controls, risk management, verification/validation, design transfer, and lifecycle change control for complex IVD products.
- Demonstrated ability to independently make and defend difficult technical quality decisions using sound regulatory and scientific judgment.
- Strong knowledge of FDA QMSR, ISO 13485, ISO 14971, and associated product development documentation expectations.
Preferred Work Experience:
- Experience with complex IVD platforms, companion diagnostics, software-enabled systems, or multi-site development programs.
- Experience supporting external customer or partner-facing development programs, including pharma collaborations.
- Lead auditor or advanced risk management training.
- Experience in multi-line or multi-site IVD manufacturing environments and in organizations with significant regulatory visibility or remediation demands.
- Professional certification in quality or auditing is a plus.
Physical and Mental Requirements:
- Strong attention to detail for thorough documentation to ensure consistency in documentation.
- Excellent problem-solving skills to identify and address quality issues effectively.
- Ability to manage multiple projects to meet deadlines while maintaining accuracy.
Knowledge:
- Strong working knowledge of FDA QMSR, ISO 13485, ISO 14971,GMP, and practical application of risk-based quality system management.
Skills:
- Demonstrates strong technical judgment and an ability to apply regulatory and quality requirements to real operational decisions.
- Communicates clearly across technical and non-technical stakeholders and maintains high standards for documentation quality.
- Balances speed, compliance, and product quality without compromising patient safety, product performance, or regulatory expectations.
- Leads with accountability, develops talent, and creates an operating environment that is disciplined, responsive, and audit ready.
Travel required
Education:
- Bachelor's degree in Engineering, Life Sciences, or related technical field; advanced degree strongly preferred. (Required)
