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Senior Process Engineer — Medical Device NPI
Senior Process Engineer — Medical Device NPIAvalign Technologies • Fort Wayne, IN, US
Senior Process Engineer — Medical Device NPI

Senior Process Engineer — Medical Device NPI

Avalign Technologies • Fort Wayne, IN, US
22 hours ago
Job type
  • Full-time
  • Quick Apply
Job description

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
  • Create a job alert for this search

    Engineer Medical Device • Fort Wayne, IN, US

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