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 EngineeringISO 13485Design for Manufacturability (DFM)ISO 9001 Certification ExperienceEngineering Degree