New Product Introduction (NPI) Sr. Manager/Director

Nextern•Maple Grove, MN

5d•$150,000 - $200,000

About The Position

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.

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
Proficiency with MS Office Suite (Word, Excel, PowerPoint, Project, Outlook)

Nice To Haves

Master’s Degree or MBA preferred
Experience with PLM systems (e.g., Windchill, Agile, Propel)

Responsibilities

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