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New Product Introduction Process Engineer (Senior)

New Product Introduction Process Engineer (Senior)

Avalign TechnologiesFort Wayne, IN, US
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Job Description

Job Description

Are you the engineer who can turn a print into a production-ready reality?

If you can coordinate cross-functional teams, manage timelines, and translate customer specifications into reliable manufacturing processes, this Senior NPI Process Engineer role is for you. Imagine guiding a new product from first article through internal volume production—while keeping suppliers, customers, and our plant synchronized and compliant every step of the way.

Does this sound like you?

  • Do you enjoy being the go-to liaison for customers and internal teams on both new and legacy projects?
  • Can you build Device Master Records (DMR) , define DFM -driven processes, and lock in quality, cost, and delivery?
  • Are you comfortable quoting projects—estimating costs, setting pricing margins, and aligning with corporate financial targets?
  • Will you lead new product efforts as the project manager to ensure on-time delivery and compliance with ISO, FDA , and customer requirements?
  • Do you lean into continuous improvement and tackle Non-Conformance Material Reports (NCMR) to safeguard compliance post-production?
  • Can you proactively communicate initiatives that help the department, plant, and company hit operational goals?

What you will do

  • Orchestrate cross-functional collaboration (customer service, manufacturing, quality, scheduling, purchasing) for NPIs and sustaining work.
  • Act as the engineering representative for product transfers through internal volume production, suppliers, and customer locations.
  • Lead projects end-to-end—scope, schedule, quality, risks, and compliance.
  • Create and manage DMRs and define manufacturing processes grounded in DFM best practices.
  • Develop accurate quotes with cost estimates and pricing margins aligned to corporate financial goals.
  • Oversee post-production activities and administer NCMR to maintain product quality and compliance.
  • Drive continuous improvement using Lean, Six Sigma, or similar methods; support quality, operations, and purchasing to meet corporate objectives.

    • Minimum qualifications

  • Bachelor’s degree in an engineering discipline with 5+ years of manufacturing experience, or an equivalent combination of education and experience.
  • Experience in ISO 13485 , ISO 9001 , or medical device manufacturing (preferred).
  • Demonstrated success with NPI and legacy product lifecycle management.
  • Experience handling NCMR and post-production compliance.
  • Knowledge of continuous improvement methodologies (Lean, Six Sigma, or similar).

    • Who will love this role

  • A self-starter who thrives in a fast-paced environment.
  • A quick learner eager to deepen manufacturing process knowledge.
  • A dependable teammate who shows up when it counts.
  • Someone open, cooperative, positive, and team-oriented.
  • A planner who can coordinate and execute across teams.
  • An effective communicator—both written and verbal.

    • What you won’t experience here

  • Feeling stuck – we offer great opportunities to advance and learn.
  • Monotony – we make a high variety of products, so no day is the same.
  • Being just a number – we’re a close-knit bunch and always have each other’s backs.

    • Perks and benefits

  • Competitive compensation and benefits package.
  • Medical, dental, and vision insurance.
  • Paid vacation and 10 observed paid holidays per year.
  • Employer funded Basic Life and AD&D insurance.
  • Employer funded STD and LTD insurance.
  • Tuition reimbursement.
  • 401(k) with company match.
  • Generous employee referral bonus program.
  • A thriving, performance-based company that promotes from within and supports career advancement.
  • Temperature controlled environment.
  • Community involvement—investing in and giving back to the community.
  • Additional free resources such as travel assistance and EAP.

    • Preferred proficiencies

  • Industrial and Manufacturing Engineering
  • ISO 13485
  • Design for Manufacturability (DFM)
  • ISO 9001 Certification Experience
  • Engineering Degree
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