Senior Development Quality Engineer

Role: Sr. Development Quality EngineerSalary: $115,000 - $125,000Location: 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 reportingAuthor and manage Master Validation Plans, control plans, test plans, and work instructionsDrive root cause analysis and support CAPA activities during development and NPIFacilitate and maintain PFMEAs and risk documentationConduct process capability analysis and interpret statistical data (Minitab)Partner cross-functionally on new product introduction, process development, and qualification activitiesSupport inspection and measurement method development, including appropriate tooling and gaging strategies Qualifications / Requirements:Bachelor's degree in Engineering or related technical field5-7 years of quality engineering experience in medical device manufacturingStrong hands-on validation authoring experience (MVPs, IQ/OQ/PQ, TMV, PFMEA, etc.)Working knowledge of ISO 13485, GMP, and FDA-regulated environmentsExperience in automated manufacturing environments (converting/rotary is a plus)Solid statistical background with Minitab proficiencyAbility to read blueprints and apply GD&TStrong 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 baseBonusFull 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.