Director, NPI

About us:

We know what it takes to be a key partner in life science and medical industries. Since 2002, Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering design services and manufacturing complex instruments, software, and consumables.  Our customers are striving for breakthroughs in research instruments and medical diagnostic and surgical devices that will help scientists and medical professionals understand patient conditions and provide better treatment. Gener8 has offices in San Jose and Carlsbad, CA, Wilmington, MA, Indianapolis, IN and Cartago, Costa Rica.  

The Director of NPI Engineering leads the cross-functional introduction of new products from concept through production launch. This role is responsible for building scalable NPI processes, driving manufacturing readiness, validating design for manufacturability (DFM), and ensuring that new products meet quality, cost, and schedule targets. The Director oversees NPI program managers and manufacturing/industrial engineers and works closely with R&D, Product Management, Supply Chain, Quality, and Operations.

Duties and Responsibilities:

Strategic Leadership

• Develop and execute the NPI strategy, aligning engineering, operations, and business goals.
• Establish and refine NPI processes and phase-gate methodologies (e.g., PDP and PLM workflows).
• Define organizational structure, resource plans, and skill development to support growth.

Program Execution & Cross-Functional Leadership

• Lead cross-functional teams through the full NPI lifecycle: concept validation, prototyping, EVT/DVT/PVT, pilot builds, ramp-up, and full production.
• Own project timelines, budgets, risk management, and executive reporting.
• Ensure design intent, manufacturability, reliability, and compliance requirements are translated into production-capable solutions.

DFM/DFA and Manufacturing Readiness

• Drive DFM, DFA, and DFT reviews with design engineering teams.
• Oversee the development of process flows, PFMEAs, work instructions, and production tooling requirements.
• Ensure manufacturing lines, equipment, and test systems are ready for pilot and volume builds.

Supplier & Supply Chain Integration

• Collaborate with Supply Chain and suppliers to ensure component readiness, process capability, and manufacturability.
• Support vendor selection, qualification, and development for new technologies and components.

Quality & Compliance

• Partner with Quality to define validation plans, reliability testing, and regulatory documentation.
• Ensure pilot builds meet quality standards, yield targets, and product performance requirements.

Continuous Improvement

• Identify opportunities to improve cost, time-to-market, and product robustness.
• Champion Lean, Six Sigma, and operational excellence initiatives within the NPI organization.

Required Education:

• Bachelor’s degree in mechanical, Electrical, Manufacturing Engineering, or related field; master’s degree preferred.
• 10 years of experience in product development or manufacturing engineering, including 5 years in NPI leadership roles.
• Proven success launching complex hardware or electro-mechanical products into production.
• Deep understanding of DFM principles, manufacturing processes, reliability engineering, and quality systems.
• Strong program management skills with experience managing multi-disciplinary teams.
• Excellent communication skills, including executive-level reporting and stakeholder management.

Required Experience:

• 10 years of experience in product development or manufacturing engineering, including 5 years in NPI leadership roles.
• Proven success launching complex hardware or electro-mechanical products into production.
• Deep understanding of DFM principles, manufacturing processes, reliability engineering, and quality systems.
• Strong program management skills with experience managing multi-disciplinary teams.
• Excellent communication skills, including executive-level reporting and stakeholder management.

Company Benefits:

Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program.