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Nissha Medical Technologies · 2 weeks ago

Director of New Product Introduction (NPI)

Buffalo, NY

Contract

Onsite

Director/Executive

$170K/yr - $190K/yr

10+ years exp

Nissha Medical Technologies is hiring for a Director of New Product Introduction (NPI). This role is critical in managing cross-functional collaboration to ensure seamless and compliant product launches for new medical device programs within a contract manufacturing environment.

Consumer GoodsManufacturingMedical Device

Responsibilities

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

NMT’s central liaison between internal teams (engineering, regulatory, quality, supply chain, production) and the customer sponsor (Internal customer and OEM clients)

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)

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)

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

Drive the implementation of robust manufacturing processes including process validations (e.g., sterilization, packaging, assembly)

Typically though Program Management team, provide regular program updates to customers, manage expectations, and maintain high customer satisfaction

Identify and mitigate technical, regulatory, and operational risks throughout the NPI process

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

Qualification

NPI leadershipFDA regulationsISO 13485 complianceDesign transferMedical device experienceProcess developmentPLM systemsProject management softwarePMP certificationCustomer-facing skillsCommunication skillsLeadership skills

Required

Bachelor's degree in Engineering, Life Sciences, or related field

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)

Excellent communication, leadership, and customer-facing skills

Preferred

Master's or MBA

PMP certification is a plus

Benefits

Company Culture: At Nissha, we pride ourselves on cultivating an atmosphere of teamwork where all associates feel heard and valued.

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.