Acara Solutions client in the Medical Technology industry is looking for a
Director of New Product Introduction (NPI) to join their team!
Location: Buffalo, NY (Preferred - open to Nashville, TN)
Duration: Fulltime/Direct Hire
Pay Rate: Up to $190k (Depending on experience)
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 the clients 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.
Required Skills / 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).
Preferred Skills / Qualifications:
- PMP certification is a plus.
Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct) are an Equal Opportunity Employer. Race/Color/Gender/Religion/National Origin/Disability/Veteran.
Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
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Aleron
Aug 22, 2025