Senior Program Manager, Medical Systems - Judge Group

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.