Engineering Manager, NPI
About The Position
The NPI Engineering Manager will lead and develop the Engineering team with primary responsibility for New Product Introduction (NPI), product industrialization, and process development. This role is accountable for successfully transferring new products from concept and design into production by establishing robust manufacturing processes, validation strategies, and scalable production systems. The NPI Engineering Manager will partner closely with customers, Operations, Quality, Manufacturing, and Supply Chain to ensure new products meet safety, quality, delivery, and cost objectives while supporting long-term business growth. This role will primarily support metal-centric medical device products and manufacturing processes. Additionally, this leader will collaborate with the site leadership team to grow partnerships with new and existing customers by promoting a culture of consistently meeting or exceeding customer expectations through Continuous Improvement, Operational Excellence, and High-Performance Teams.
Requirements
- Bachelor of science degree in Engineering or related discipline, advanced degree preferred
- 7+ years of engineering experience in a regulated manufacturing environment, preferably within the medical device industry.
- 4+ years of demonstrated people leadership, technical leadership, or project leadership, including responsibility for engineering teams and cross-functional programs.
- Demonstrated experience leading NPI, product industrialization, process development, design transfer, validation, and commercialization projects.
- Experience with metal-centric manufacturing processes and precision component production strongly preferred.
- Working knowledge of FDA, ISO, OSHA, and applicable quality-system requirements.
- Strong leader, clear communicator, and highly organized project manager with the ability to manage multiple customer programs and competing priorities.
- Excellent interpersonal, conflict-resolution, team-building, and influencing skills across technical, operational, and customer-facing environments.
- Strong understanding of design transfer, manufacturing process development, process validation, product commercialization, and production ramp-up within a regulated Quality Management System.
- Strong understanding of FDA and ISO requirements applicable to medical device development and manufacturing.
- Demonstrated track record of creative problem solving, risk reduction, and successful product launches.
- Direct experience with process characterization, Design of Experiments, capability analysis, and statistical methods, including t-tests, ANOVA, and significance testing.
- Expertise in technical documentation, including engineering reports, risk assessments, protocols, IQ/OQ/PQ documentation, Engineering Studies, SOPs, and work instructions.
- Advanced proficiency with Microsoft Office, Excel, and Minitab.
Nice To Haves
- Lean Six Sigma Green Belt preferred; Black Belt certification is a plus.
Responsibilities
- Lead NPI activities from concept through commercialization, production launch, and stable handoff to Operations.
- Manage engineering resources, project priorities, timelines, and budgets to support customer development programs, business growth initiatives, and manufacturing readiness objectives.
- Partner directly with customers and internal teams on Design for Manufacturability (DFM), Design for Assembly (DFA), technical reviews, risk assessments, quoting support, and design transfer activities.
- Develop and implement robust manufacturing processes for medical device components and assemblies, with emphasis on metal-centric technologies such as CNC machining, Swiss turning, precision grinding, laser processing, metal forming, finishing, and secondary operations.
- Drive process characterization, Design of Experiments, equipment qualification, process development, and validation activities, including IQ, OQ, PQ, and controlled Engineering Studies when supported by approved rationale.
- Lead cross-functional teams to execute product launches within established safety, quality, delivery, cost, and budget expectations.
- Develop manufacturing readiness plans addressing equipment, tooling, fixtures, gauges, inspection methods, work instructions, capacity, staffing, supply chain, and production controls.
- Evaluate and implement new manufacturing technologies, automation solutions, capital equipment, and tooling to support product requirements and future business growth.
- Ensure NPI activities comply with Viant Quality System requirements, FDA regulations, ISO standards, customer requirements, and EHS policies.
- Apply lean manufacturing, risk management, and project management methodologies to improve engineering execution and accelerate commercialization timelines.
- Translate customer and product requirements into scalable manufacturing solutions that deliver capable processes, quality performance, and operational efficiency.
- Promote accountability, innovation, collaboration, and continuous learning within the engineering team.
- Support team development through coaching, performance reviews, succession planning, and alignment with Viant values and career growth opportunities.
Benefits
- Medical, dental, and vision benefits
- Company-paid life insurance and disability benefits
- Generous Paid time off and 10 paid Holidays
- 401k Plan with Company Match
- Tuition Reimbursement
- Voluntary Universal Life and Long-Term Care
- Voluntary Legal Plan
- Pet Insurance
- Home Ownership Program
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What This Job Offers
Job Type
Full-time
Career Level
Manager
