Job Description

Overview

• 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

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.

~10% Travel (possible)

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