Bachelor's degree in Engineering or related technical discipline required; Master's degree preferred.
Minimum of 3 years of project management experience in the medical device industry;
Preferred experience with single-use medical devices, endoscopes, or surgical systems.
At least 2 years' experience in areas like Endoscopy or Digital Image Processing preferred.
Experience with manufacturing transfer activities including validation and documentation processes.
Responsibilities
Assist in planning and coordinating medical device development projects across departments.
Prepare project plans, schedules, and reports for senior leadership.
Support project execution activities across Engineering, Regulatory, and Quality.
Identify risks, escalate issues, and assist in creating mitigation plans.
Monitor project progress and assist in implementing corrective actions.
Drive accountability and prioritize tasks for timely project completion.
Support compliance with design control processes and effective communication.
Benefits
Collaborative work environment with cross-functional teams.
Opportunities for professional growth and development.
Engagement with cutting-edge medical device technology.
Commitment to quality and compliance in the medical device sector.
Full Job Description
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.
Qualifications
Education
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
About IPG Photonics
IPG Photonics is a leading developer and manufacturer of high-performance fiber lasers and amplifiers for diverse applications in numerous markets. IPG Photonics' diverse lines of low, medium and high-power lasers and amplifiers are used in materials processing, communications, entertainment, medical, biotechnology, scientific and advanced applications.
