Description: The Judge Group is seeking a Senior Program Manager for Medical Systems. This is a full time role in Marlborough, MA working fully onsite.
The ideal candidate will have prior experience managing an entire program start to finish and have Endoscopic experience preferably and someone who has worked on a program involving Complex Disposables.
Responsibilities:
Plan and directly manage cross-functional projects, including external resources and contracted companies.
Formulate and gain approval for overall project plans in consultation with senior management, CDMOs, Regulatory, Quality, Manufacturing, and other stakeholders.
Proactively identify and assess areas of risk, escalate issues in a timely manner, and develop solutions, including contingency plans to address program risks and resolve technical knowledge gaps that hinder program progress.
Partner with development team members to drive accountability and ensure high-quality project tasks and deliverables. Continuously prioritize team member activities and follow up on actions.
Manage program budgets, generate forecasts, and track actuals against forecasts.
Monitor progress to plan and implement corrective actions or contingencies as needed to maintain commitments.
Provide management with regular project status updates, variances to plan, and identification of corrective actions.
Work closely with functional management to gain resource commitments and resolve issues.
Provide input to directors/managers and senior management on team member performance. Effectively manage performance issues and conflicts.
Oversee and facilitate compliance with design control and product development processes.
Ensure project team activities and decisions are clearly communicated and documented.
Requirements:
Education:
Degree in Engineering discipline, MS preferred.
Experience:
Minimum of 15 years of medical device experience, with at least 4 years in areas such as endoscopy, digital image processing, and systems engineering (preferred).
Minimum of 5 years of project management experience in single-use medical devices, preferably with endoscopes and peripheral equipment and accessories.
Advanced skills in project management, project reporting, and presentations.
Working knowledge of MS Project or equivalent project planning software.
Experience with the transfer to manufacturing of medical products, including the management of IQ, OQ, PQ, DMRI, work instructions, product specifications, PFMEAs, MVPs, and other transfer-related documentation.
Proven track record of executing complex multi-functional projects on time and within budget.
Ability to manage multiple project work streams in a fast-paced development environment.
Proven experience working within a controlled "Stage Gate" product development process.
Knowledge of design controls and risk management practices, regulations, and standards, such as FDA QSR's, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825, and 62366, is preferred.
Contact: amassad@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
