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Senior Manufacturing Engineer – Medical Device NPI

Senior Manufacturing Engineer – Medical Device NPI

Avalign TechnologiesFort Wayne, IN, US
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Build a career launching products that matter

Join us as a Senior Manufacturing Engineer – Medical Device NPI and take ownership of introducing new products that meet exacting customer, site-specific, and regulatory requirements. You’ll coordinate across teams, suppliers, and customer locations to convert specifications into robust processes and on-time deliveries—while sustaining legacy products with the same rigor.

Role impact

  • Lead cross-functional planning with customer service, manufacturing, quality, scheduling, and purchasing to deliver smooth NPIs and strong sustainment on existing lines.
  • Act as the customer-facing engineering representative, aligning internal teams and customers on goals, requirements, and expectations for new and legacy projects.
  • Manage project schedules and deliverables to satisfy quality targets, delivery dates, and ISO, FDA , and customer standards.
  • Own Device Master Records (DMR) and manufacturing process documentation; drive DFM decisions that balance cost, quality, and delivery.
  • Develop quotes that capture cost estimates, pricing margins, and alignment with corporate financial goals.
  • Guide transfers into internal volume production and coordinate with suppliers and customer locations as needed.
  • Oversee post-production activities and govern Non-Conformance Material Reports (NCMR) to maintain compliance and quality.
  • Advance continuous improvement initiatives (Lean, Six Sigma, or similar) while supporting quality, operations, and purchasing against corporate objectives.
  • Proactively communicate initiatives that support departmental, plant, and corporate operational goals.

Qualifications

  • Bachelor’s degree in an engineering discipline plus 5+ years in manufacturing, or an equivalent mix of education and experience.
  • Experience in ISO 13485 , ISO 9001 , or medical device manufacturing environments (preferred).
  • Track record with NPI execution and legacy product lifecycle management.
  • Experience with NCMR and post-production compliance activities.
  • Familiarity with continuous improvement approaches (Lean, Six Sigma, or similar).
  • Mindset that fits

  • Self-starter who thrives in fast-paced settings.
  • Curious, quick learner with a drive to deepen manufacturing process expertise.
  • Dependable and accountable when timelines are tight.
  • Collaborative, positive, and team-oriented.
  • Organized planner who can coordinate and execute across functions.
  • Strong written and verbal communicator.
  • Culture and growth

    We’re performance-based, people-centered, and focused on internal mobility. You won’t feel stuck, get bored, or feel like just a number—our product mix keeps work fresh, and our close-knit team has your back.

    Compensation and benefits

  • Competitive compensation and benefits package.
  • Medical, dental, and vision coverage.
  • Paid vacation plus 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.
  • Promotion-from-within philosophy with real career advancement.
  • Temperature controlled environment.
  • Community involvement—investing in and giving back to the community.
  • Additional free resources such as travel assistance and EAP.
  • Core proficiencies

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