Senior Project Manager - Instruments & Accessories

The Senior Project Manager - Instruments & Accessories is responsible for leading and executing the full product development lifecycle of medical device instruments and accessories, 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 provides strategic leadership and tactical execution across all stages of product development, 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.

- Define program strategy, execution pathways, and development milestones for I&A product lines. - Drive alignment across engineering, clinical, operations, and product management teams to ensure product and portfolio goals are met. - Lead decision-making forums, business reviews, and roadmap integration discussions with senior leadership.

- 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 design, human factors, and engineering teams to ensure product requirements, usability, and performance criteria are met.

- Drive manufacturing readiness, including process development, supply chain coordination, build readiness, and launch planning. - 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.

- 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.

- Bachelor's degree in Mechanical, Electrical or Biomedical Engineering or a related technical field; advanced degree preferred. - Minimum of 7 years' experience in medical device product development, with demonstrated leadership in instrument and accessory 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. - Strong organizational skills, including planning, prioritization, and risk management.

- Experience in robotic surgery, laparoscopic instrumentation, 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.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

Skills, Experience, Education, & Training:

• Bachelor’s degree in Mechanical, Electrical or Biomedical Engineering or a related technical field; advanced degree preferred.
• Minimum of 7 years’ experience in medical device product development, with demonstrated leadership in instrument and accessory 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.
• Strong organizational skills, including planning, prioritization, and risk management.

• Experience in robotic surgery, laparoscopic instrumentation, 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. Primary Function of Position:

The Senior Project Manager – Instruments & Accessories is responsible for leading and executing the full product development lifecycle of medical device instruments and accessories, 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 provides strategic leadership and tactical execution across all stages of product development, 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.

• Define program strategy, execution pathways, and development milestones for I&A product lines.
• Drive alignment across engineering, clinical, operations, and product management teams to ensure product and portfolio goals are met.
• Lead decision-making forums, business reviews, and roadmap integration discussions with senior leadership.

• 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 design, human factors, and engineering teams to ensure product requirements, usability, and performance criteria are met.

• Drive manufacturing readiness, including process development, supply chain coordination, build readiness, and launch planning.
• 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.

• 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.