The Assistant Project Manager supports the planning, coordination, and execution of cross-functional medical device development projects for Integrated Surgical Platforms within IPG Medical Corporation. This role partners closely with Engineering, Regulatory, Quality, Manufacturing, CDMOs, and other stakeholders to help ensure projects are delivered on time, within budget, and in compliance with applicable medical device regulations and design control requirements.
The ideal candidate brings strong project coordination capabilities, technical knowledge of medical device development, and the ability to operate effectively in a fast-paced, regulated product development environment.
Essential Responsibilities- Assist in planning, coordinating, and managing cross-functional medical device development projects, including collaboration with external partners, suppliers, and contract manufacturers.
- Prepare project plans, schedules, status reports, presentations, and supporting materials for review with senior leadership and key stakeholders.
- Support project execution activities across Engineering, Regulatory, Quality, Manufacturing, and Operations functions.
- Proactively identify project risks, escalate issues appropriately, and support the development of mitigation and contingency plans.
- Monitor project progress against established timelines, budgets, and deliverables; assist in implementing corrective actions when needed.
- Partner with development team members to drive accountability, prioritize activities, and ensure timely completion of project tasks and deliverables.
- Assist in managing program budgets, forecasting project costs, and tracking actual spending against approved budgets.
- Support compliance with medical device design control and product development processes, including documentation and change management activities.
- Ensure project activities, meeting outcomes, decisions, and action items are effectively communicated and documented.
- Contribute input regarding team collaboration, project execution, and performance observations to Project Managers and functional leaders.
- Support manufacturing transfer activities for medical products, including coordination of transfer documentation and validation-related activities.
QualificationsEducation- Bachelor's degree in Engineering or related technical discipline required.
- Master's degree preferred.
Experience- Minimum of 3 years of project management experience within the medical device industry.
- Preferred experience supporting single-use medical devices, endoscopes, peripheral equipment, or related surgical systems.
- Minimum of 3-5 years of overall medical device industry experience preferred.
- At least 2 years of experience in one or more of the following areas preferred:
- Endoscopy
- Digital image processing
- Systems engineering
- Experience supporting manufacturing transfer activities for medical products, including:
- IQ/OQ/PQ validation activities
- DMR documentation
- Work Instructions
- Product Specifications
- PFMEAs
- MVPs and related transfer documentation
- Demonstrated experience supporting medical device development projects in a regulated environment.
- Experience working within a formal Stage Gate product development process preferred.
- Proven ability to manage multiple workstreams in a fast-paced development environment.
Technical Skills & Knowledge- Working knowledge of Microsoft Project or equivalent project planning software.
- Strong project planning, reporting, and presentation skills.
- Excellent written and verbal communication skills.
- Knowledge of medical device design controls, risk management, and applicable regulations and standards preferred, including:
- FDA Quality System Regulations (QSR)
- ISO 13485
- EU MDR
- ISO 14971
- IEC 60601
- IEC 60825
- IEC 62366
Core Competencies- Cross-functional collaboration
- Organizational and time management skills
- Risk identification and problem solving
- Attention to detail and documentation accuracy
- Ability to manage competing priorities
- Strong interpersonal and communication skills
- Accountability and follow-through
- Adaptability in a dynamic development environment
