Sr Project Manager

Job description

Primary Function of Position

The Senior Project Manager is responsible for leading and executing the full product development lifecycle of medical device endoscopes and end to end vision pipeline, from initial concept through commercial launch. This role requires deep expertise in medical device development, regulatory pathways, operations, sterilization, biocompatibility, and cross-functional project management. The Senior Project Manager serves as a key driver of product innovation, compliance, and operational excellence within the organization.

The Senior Project Manager leads cross-functional execution across all phases of product development, from concept through commercial launch, including concept generation, design, prototyping, verification and validation, regulatory submissions, manufacturing transfer, and launch. The role is pivotal in ensuring that all products meet stringent compliance requirements, including FDA, EU MDR, ISO standards, and relevant quality system regulations.

Roles & Responsibilities

Strategic Leadership. Execute development plans aligned with product roadmap objectives. Develop project execution plans, development milestones, and cross-functional plans for Endoscope development programs. Facilitate program reviews and decision-making discussions with functional and senior leaders to resolve issues, align priorities, and maintain program momentum. Product & Design Development Lead cross-functional teams through concept development, design iteration, prototyping, verification/validation, and design transfer to manufacturing.

Maintain clear project plans, schedules, risks, and resource allocation. Partner with engineering teams to drive development of optical, mechanical, illumination, imaging, and sterilization solutions that meet product performance requirements. Coordinate verification and validation activities, ensuring successful execution of testing, defect resolution, and readiness for regulatory submissions. Lead comprehensive risk management across multiple workstreams by ensuring risks are identified, analyzed, prioritized, communicated, and used to inform trade-off decisions.

Translate technical, regulatory, operational, and business content into accessible written and oral communications for varied audiences, including reports, project updates, decision summaries, and leadership deliverables. Operational Execution Drive manufacturing readiness, including process development, supply chain coordination, build readiness, launch planning, budget inputs, financial assumptions, and cross-functional execution across multiple workstreams.

Ensure smooth transition from R&D to operations with strong cross-functional integration and documentation rigor. Support ongoing product lifecycle, cost reductions, reliability improvements, and sustainment workstreams. Partner with Finance and functional leaders to validate financial assumptions, provide budget inputs across workstreams, monitor project financials, and manage trade-offs to remain within approved commitments.

Regulatory & Compliance Ensure project deliverables meet relevant US and global medical device standards and quality system requirements. Coordinate cross-functional preparation of regulatory documentation and testing. Champion strong design controls, risk management, and audit-ready documentation throughout the lifecycle.

Qualifications

Skills, Experience, Education, & Training

Required: Bachelor’s degree in Mechanical, Electrical or Biomedical Engineering or a related technical field; advanced degree preferred. At least a minimum of 7 years’ experience in medical device product development, with demonstrated leadership in Endoscope or Vision projects from concept to launch. In-depth knowledge of medical device regulatory pathways (FDA, EU MDR, ISO 13485), submission requirements, and quality system regulations.

Experience collaborating with engineering, operations, regulatory, quality, and clinical teams throughout all development phases. Exceptional communication and stakeholder-management skills. Ability to handle ambiguity effectively and oversee multiple medium size projects at once Strong organizational skills, including planning, prioritization, and risk management.

Preferred

Experience in robotic surgery, laparoscopic endoscopes, or electro-mechanical medical devices. PMP certification or formal project management training. Familiarity with ALM/PLM systems, Agile methodologies, and project management tools. Expertise in operations, manufacturing processes, sterilization methods (e.g., EtO, autoclave, gamma), and biocompatibility assessment. Start-up experience desired