Ready to launch products right the first time?
If you’re energized by complex builds, tight timelines, and regulated environments, this role is for you. As a Senior Process Engineer focused on NPI in medical device and regulated manufacturing, you’ll orchestrate the methods, documentation, and cross-functional coordination required to meet site, customer, and regulatory expectations—while keeping delivery promises.
Role at a Glance
- Drive new product introductions and support sustaining production across customer service, manufacturing, quality, scheduling, and purchasing.
- Be the primary interface for customers and internal teams on new and legacy work—clarifying requirements, risks, and milestones.
- Assemble accurate project quotes, capturing costs, margins, and alignment with corporate financial goals.
- Lead NPI projects end-to-end, ensuring quality outcomes and adherence to ISO, FDA, and customer standards.
- Build and maintain DMRs; establish robust processes and DFM strategies to improve cost, quality, and delivery.
- Own post-production controls and manage NCMR to maintain compliance and product performance.
- Advance continuous improvement; enable quality, operations, and purchasing to meet organizational targets.
Qualifications
Bachelor’s in engineering and 5+ years of manufacturing experience, or equivalent education / experience mix.Experience in ISO 13485, ISO 9001, or medical device manufacturing preferred.Track record with NPI and lifecycle stewardship of legacy products.Proficiency managing NCMR and post-production compliance activities.Working knowledge of Lean, Six Sigma, or comparable CI frameworks.Do these statements sound like you?
I’m a self-starter who excels in fast-moving environments.I learn new manufacturing processes quickly and thoroughly.My team counts on me—I show up and deliver.I take on assignments with positivity and collaborate well.I plan the work and work the plan across multiple teams.I communicate clearly in writing and in person.What You Won’t Experience
Stagnation—growth and learning are built in.Monotony—product variety keeps things interesting.Anonymity—we value and support each other.Perks & Benefits
Competitive compensation and full benefits.Medical, dental, and vision insurance.Paid vacation plus 10 observed paid holidays.Employer-paid Basic Life and AD&D.Employer-paid Short-Term and Long-Term Disability.Tuition reimbursement for continued learning.401(k) with company match.Employee referral bonus program.Career advancement—promotion from within.Temperature-controlled facilities.Opportunities to give back to the community.Extras like travel assistance and EAP.Proficiency
ISO 13485