New Product Introduction (NPI) Sr. Manager/Director
Nextern is a growing medical device manufacturing company committed to excellence, innovation, and investing in our people. We offer a collaborative workplace where your contributions matter and your career can grow. If you're passionate about quality, teamwork, and being part of work that truly makes a difference, we invite you to join our team.
Resposibilites
Acts as overall owner and leader of New Product Introduction programs, accountable for:
- Leading cross-functional NPI core teams through the full product lifecycle, from concept development through commercial launch and post-launch support
- Establishing and executing NPI stage-gate processes, timelines, budgets, and resource plans
- Ensuring alignment of product development activities with customer requirements, business strategy, and operational capabilities
- Driving Design Transfer activities to manufacturing, ensuring readiness for pilot builds, validation, and full-scale production
- Partnering with Quality and Regulatory teams to ensure compliance with applicable regulations and standards (e.g., 21 CFR 820, ISO 13485, ISO 14971, EU MDR)
- Overseeing risk management activities, including identification, mitigation, and escalation of technical, regulatory, supply chain, and program risks
- Ensuring product and process validation strategies are defined and executed (e.g., DV, PV, IQ/OQ/PQ)
- Collaborating with Supply Chain and Supplier Quality to qualify suppliers, materials, and external manufacturing partners
- Supporting development and maintenance of product documentation including DHF, DMR, and technical transfer packages
- Monitoring program performance and proactively identifying opportunities for efficiency, cost reduction, and continuous improvement
Requirements
- Bachelor's Degree (BS) in Engineering, Life Sciences, or related discipline required; Master's Degree or MBA preferred
- 10+ years of experience in medical device development, manufacturing, or program management
- 5+ years of experience leading complex NPI or product development programs in a regulated environment
- Strong working knowledge of medical device quality systems and regulations (21 CFR 820, ISO 13485, ISO 14971)
- Demonstrated success leading cross-functional teams through multiple product launches
- Strong understanding of Design Controls, Design Transfer, and manufacturing readiness
- Experience working with global teams, customers, and suppliers
- Proven ability to manage complex schedules, budgets, and competing priorities
- Excellent communication, leadership, and stakeholder management skills
- High attention to detail with a proactive, problem-solving mindset
- Experience with PLM systems (e.g., Windchill, Agile, Propel) preferred
- Proficiency with MS Office Suite (Word, Excel, PowerPoint, Project, Outlook)
Benefits
Highly Competitive Compensation Package
Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.