Staff Design Control Engineer, Design Quality (IVD/CDx/Medical Device))

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.

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®

· healthyMINDS mental health program

· Vacation and Health/Flex Time

· 6 Holidays plus 1 "MyDay" off

· FinFit 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.