Director of New Product Introduction (NPI)

Nissha Medical Technologies is hiring for a Director of New Product Introduction. This position can sit at one of our sites in either Buffalo, NY or Nashville, TN.

The Director of New Product Introduction (NPI) will lead the successful onboarding and ramp-up of new medical device programs within a contract manufacturing environment. This role is critical in managing cross-functional collaboration between customers, engineering, quality, regulatory, procurement, and manufacturing teams to ensure seamless and compliant product launches.

You will be the primary interface to execute on the customer commitments defined by the OEM's product development teams and internal operations, ensuring design transfer, validation, and manufacturing scale-up meet cost, quality, and timeline objectives while complying with FDA and ISO 13485 standards.

Key Responsibilities:

• Program Execution Leadership: Own and lead the full NPI lifecycle from Project Kick-off as onboarded by Business Development and/or Program Management, through design transfer, pilot production, validation, and full-scale manufacturing.
• Cross-Functional Coordination: NMT's central liaison between internal teams (engineering, regulatory, quality, supply chain, production) and the customer sponsor (Internal customer and OEM clients)
• Manufacturing Transfer: Ensure complete and compliant product design is transferred from NMT's Design Engineering Team and/or OEM Client's design to Nissha's manufacturing floor, including development of DMRs (Device Master Records) and DHFs (Design History Files).
• Regulatory & Quality Compliance: Ensure new product launches meet FDA 21 CFR Part 820 and ISO 13485 requirements. Partner with quality and regulatory teams to support validation protocols (IQ, OQ, PQ).
• Timeline & Budget Management: Develop and execute to NPI schedules, resource plans, and budgets. Support management of schedules in the absence of Program Management leadership. Deliver products on time and within cost constraints as committed to customer within the scope of business proposals and/or clients statements of work.
• Process Development: Drive the implementation of robust manufacturing processes including process validations (e.g., sterilization, packaging, assembly).
• Customer Communication: Typically though Program Management team, provide regular program updates to customers, manage expectations, and maintain high customer satisfaction.
• Risk Management: Identify and mitigate technical, regulatory, and operational risks throughout the NPI process.
• Team Leadership: Build, lead, and mentor an NPI team that includes project managers, engineers. Indirect leadership support to build customer-focused quality, supply chain, and operational teams for new product launches.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field (Master's or MBA preferred).
• 10+ years of experience in medical device manufacturing, with at least 5 years leading NPI or project management functions.
• Strong knowledge of FDA regulations (21 CFR Part 820), ISO 13485, ISO 14971, and MDR/IVDR compliance.
• Experience working with Class I, II, or III medical devices, ideally in a contract manufacturing or OEM setting.
• Proven experience in design transfer, validation (IQ/OQ/PQ), and process development for regulated products.
• Familiarity with PLM systems, ERP tools, and project management software (e.g., MasterControl, Arena, SAP, MS Project).
• PMP certification is a plus.
• Excellent communication, leadership, and customer-facing skills

Nissha Medical Technologies is committed to fair, competitive, and market-informed pay for our employees. The pay range for this position is $170,000-190,000 Annual (USD). The successful candidate's particular combination of knowledge, skills, and experience will inform their specific compensation.

Why choose Nissha to build your career?

At Nissha, you can be assured that you will be part of a dynamic, diverse team that is committed to bringing the best versions of ourselves each and every day. We recently received the "General Excellence" manufacturing award from Buffalo Business First, which highlights our dedication to quality, innovation, and sustainability. This recognition celebrates the hard work of our team in producing high-quality medical devices that meet industry standards and enhance patient care. If you are looking for meaningful work that motivates and inspires, you've come to the right place!

What we offer that you'll love...

• Company Culture: At Nissha, we pride ourselves on cultivating an atmosphere of teamwork where all associates feel heard and valued. We may not all think the same, and we wouldn't have it any other way.
• Diversity & Inclusion: We are committed to equity, racial justice, and equal opportunity for all.
• Training and Development opportunities: Because we foster a culture of continuing education. Let's learn and grow together!
• Team Building, Connection, and Relationships: We support each other, celebrate our achievements and milestones together, and have FUN.
• Retirement: We know you want to retire comfortably and we're here to help! Nissha offers a 401(k) Retirement Plan with an attractive employer contribution.
• Time Away from Work: Whether it is vacation or sick leave, we all need time to recharge. Paid time off is an essential associate benefit and a pillar of self-care.
• Engagement Activities: Recognition isn't just a once-a-year occurrence at Nissha. We celebrate our team members year-round with summer picnics, holiday parties, and employee spotlight events, just to name a few.
• Commitment to Wellness: We offer various opportunities to learn about your health, be healthier, and get rewarded for your healthy lifestyle by offering reduced medical premiums.

And so much MORE!