Staff Engineer, Design Quality; CDx​/FDA

Position: Staff Engineer, Design Quality (CDx/FDA)
Job Description

Pay Range: $ - $ / 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.

Benefits Information:

We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects - physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:

* Day 1 Medical, supplemental health, dental & vision for FT employees who work 30+ hours

* Best-in-class well-being programs

* Annual, no-cost health assessment program Blueprint for Wellness

* healthy

MINDS mental health program

* Vacation and Health/Flex Time

* 6 Holidays plus 1 "MyDay" off

* Fin Fit financial coaching and services

* 401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service

* Employee stock purchase plan

* Life and disability insurance, plus buy-up option

* Flexible Spending Accounts

* Annual incentive plans

* Matching gifts program

* Education assistance through MyQuest for Education

* Career advancement opportunities

* and so much more!

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.

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 inspection readiness.

* 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.

Qualifications:

Required

Work Experience:

* 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…