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.