Senior Development Quality Engineer
Role: Sr. Development Quality Engineer
Salary: $115,000 - $125,000
Location: St. Paul, MN
A well-established medical device CDMO is looking to add an engineer to their team, supporting high-impact NPI and development programs. You'll play a key role in bringing new products to life, owning validation strategy and execution while partnering closely with engineering and manufacturing teams in a fast-paced environment.
What you'll do:
- Lead execution of process and test method validations (IQ/OQ/PQ, TMV) including protocol development, data analysis, and reporting
- Author and manage Master Validation Plans, control plans, test plans, and work instructions
- Drive root cause analysis and support CAPA activities during development and NPI
- Facilitate and maintain PFMEAs and risk documentation
- Conduct process capability analysis and interpret statistical data (Minitab)
- Partner cross-functionally on new product introduction, process development, and qualification activities
- Support inspection and measurement method development, including appropriate tooling and gaging strategies
Qualifications / Requirements:
- Bachelor's degree in Engineering or related technical field
- 5-7 years of quality engineering experience in medical device manufacturing
- Strong hands-on validation authoring experience (MVPs, IQ/OQ/PQ, TMV, PFMEA, etc.)
- Working knowledge of ISO 13485, GMP, and FDA-regulated environments
- Experience in automated manufacturing environments (converting/rotary is a plus)
- Solid statistical background with Minitab proficiency
- Ability to read blueprints and apply GD&T
- Strong communication skills and ability to manage multiple projects independently
Nice to have:
- Experience in medical device contract manufacturing (CDMO)
- Exposure to CAD or GD&T software tools
Compensation:
- Competitive base
- Bonus
- Full benefits package
This is an excellent fit for a self-starter who enjoys owning validation work end-to-end and wants to be deeply embedded in NPI rather than purely sustaining quality.
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