Engineering Program Manager

Description

The Product Release Program Lead is responsible for leading, establishing, and driving execution of product release cadences for the Neuromodulation and Pelvic Health (NMPH) portfolio of products. Projects within scope will include but are not limited to: Release Product Engineering (RPE), CAPAs, Sustaining Engineering, and New Product Introduction. This position requires broad cross-functional knowledge and comprehensive business management skills.

Duties

• Accountable for overall project execution, including project planning, budgeting, schedule creation, and execution.
• Establishes product release strategy through multiple project inputs, establishing operational plans and execution.
• Leads and manages site-specific and cross-functional teams established with the purpose of successfully accomplishing the objectives of the product release program.
• Monitors progress toward pre-established objectives, assesses risks, and implements strategies to ensure successful program execution.
• Directs the work of site-specific and cross-functions through a matrix organization.
• Secures site-specific and cross-functional commitments, maintaining milestones and budget. Deploys team resources to meet project/program objectives.
• Maintains effective communication and interface with various leadership teams.
• Ensure effective project transition relevant to development, quality, manufacturing, distribution, regulatory, and commercial entities.
• Provides input to Functional Managers on team member performance, as needed.
• Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
• Develops mechanisms for monitoring and reporting project progress and for intervention and problem solving with project managers, line managers, and clients.
• Ensures the project/program complies with all aspects of the quality policy/system.
• Ensure appropriate departmental resources are assigned to the program/project and are available to effectively maintain the quality system (people, facilities, tools, and training).
• Problems and issues faced can be complex, difficult, and undefined, requiring detailed information gathering, analysis and investigation to understand the problem.
• Other responsibilities, as required and assigned.

Top 3 Required Skills

• Portfolio-wide strategy/planning for post-market product maintenance. We receive inputs on product changes from across the org, and we need to plan the timing/order of incorporating these changes into the finished goods/eManuals to support global distribution while avoiding stockouts, meeting regulatory and compliance deadlines, expediting safety-related changes, etc. Strategic thinking and planning will bbe important.
• Effective program leadership in a regulated environment plus a matrixed organization. We lead teams that are dispersed across multiple sites, working in different environments. Need to be effective at planning schedules, leading teams, meeting facilitation, risk management, project management, partnering with other project managers across the org, etc.
• Communications, progress monitoring, and reporting. Ownership of project budgets (financial planning, monitoring, and reporting), product release roadmaps (timelines for changes and new product releases across the portfolio), monthly progress reporting (to leadership, with peers / cross-functional leaders, etc.)

Must Haves

• Bachelor’s degree with 4+ years of job-related experience -OR- Master’s degree with 2+ years of job-related experience
• 2+ years of project management experience

Nice to Haves

• 2+ years coordinating manufacturing site activities.
• 5+ years in medical device product development, or other highly regulated environment.
• Project Management Professional (PMP) certified.
• Experience working with FDA, ISO, EN, and/or GMP standards.
• Highly developed skill set in project leadership practices including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes.
• Excellent downward, lateral, and upward communication skills.
• Good balance of high level strategic and detailed tactical thought processes.
• Demonstrated track record of successfully leading projects/programs to completion.