NPI/NPD Project Manager

Contract

Work Location: Newton, MA (Hybrid schedule—onsite Monday, Tuesday, and Thursday; remote on Wednesday and Friday.)

Responsibilities

• Plans and directly manages cross-functional projects that may include external resources and contracted companies
• Formulates and gains approval for overall project plans in consultation with program managers, senior management and stakeholders
• Partners with development team members to drive accountability of project tasks and deliverables
• Manages program budgets, generates forecasts, and tracks actuals against forecasts
• Monitors progress to plan and implements corrective actions or contingencies as needed to maintain commitments

Qualifications

Required skills to have for the success of this role

• B.S. in Engineering, Computer Science or related discipline
• 5-10 years of project management experience in medical device product development – from concept development through commercialization. Preferred experience in either:
• Managing new product introduction, or transfer of design to manufacturing.
• Managing verification and validation activities traced through needs and requirements
• Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and EU Medical Device Regulation
• Project Management Professional (PMP) certification preferred
• Experience managing DHR tracked deliverables preferred, including incoming inspection, configuration management & in line inspection, especially with development change control prior to commercial release.