MANIFEST Technology · 10 hours ago
New Product Introduction Manager
Maple Grove, MN
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$150K/yr - $200K/yr
10+ years expMANIFEST Technology is seeking a Program Leader for New Product Introduction (NPI) to spearhead cross-functional teams in the medical device industry. This role involves driving innovations from concept through commercial launch while ensuring compliance with industry regulations and managing program timelines and budgets.
Information ServicesInformation TechnologyProject ManagementSoftware
No H1B
Hiring Manager
Renée Adolph-Slaymaker
Responsibilities
Act 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
Qualification
Required
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)
Preferred
Master's Degree or MBA
Experience with PLM systems (e.g., Windchill, Agile, Propel)
Company
MANIFEST Technology
MANIFEST Technology delivers complete systems development life-cycle, strategy for the business, internet, and e-business services.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
John Nesser
CEO
Brigitte O'Brien Nesser
Chief Operating Officer/Partner
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