Sr Project Manager

Description

The company develops medical device endoscopes and the vision pipeline that goes with them. This senior project manager role covers a product from first concept through commercial launch.

You will work across functions to move products through concept, design, prototyping, verification and validation, regulatory submission, manufacturing transfer and launch. Products must meet FDA, EU MDR, ISO and quality system requirements.

Responsibilities

• Run endoscope development programs against roadmap goals, with written project plans, milestones and cross-functional plans.
• Hold program reviews with functional and senior leaders to settle issues, set priorities and keep work moving.
• Lead cross-functional teams through concept work, design iterations, prototyping, verification and validation, and design transfer to manufacturing.
• Keep plans, schedules, risks and resource allocation current.
• Work with engineering on optical, mechanical, illumination, imaging and sterilization solutions that meet performance targets.
• Coordinate verification and validation testing, drive defect resolution and get the work ready for regulatory submission.
• Manage risk across several workstreams: identify, analyze, rank and communicate it, and use it to guide trade-offs.
• Turn technical, regulatory, operational and business material into clear written and spoken updates, reports and decision summaries for different audiences.
• Get manufacturing ready: process development, supply chain coordination, build readiness, launch planning, budget inputs and financial assumptions.
• Make the R&D to operations handover smooth, with strong integration and careful documentation.
• Support the product lifecycle, including cost reduction, reliability improvements and sustainment work.
• Work with Finance and functional leads to check financial assumptions, supply budget inputs, track project spend and make trade-offs that stay within approved commitments.
• Make sure deliverables meet US and global medical device standards and quality system requirements.
• Coordinate cross-functional preparation of regulatory documents and testing.
• Drive strong design controls, risk management and audit-ready documentation through every phase.

Requirements

• Bachelor's degree in mechanical, electrical or biomedical engineering, or a related technical field. An advanced degree is preferred.
• At least 7 years of medical device product development experience, including leading endoscope or vision projects from concept to launch.
• Solid working knowledge of medical device regulatory pathways (FDA, EU MDR, ISO 13485), submission requirements and quality system regulations.
• Experience working with engineering, operations, regulatory, quality and clinical teams across all development phases.
• Excellent communication and stakeholder management skills.
• Comfort working through ambiguity while overseeing several medium-sized projects at once.
• Strong organizational skills, including planning, prioritization and risk management.
• Preferred: experience in robotic surgery, laparoscopic endoscopes or electro-mechanical medical devices.
• Preferred: PMP certification or formal project management training.
• Preferred: familiarity with ALM/PLM systems, Agile methods and project management tools.
• Preferred: expertise in operations, manufacturing processes, sterilization methods (such as EtO, autoclave and gamma) and biocompatibility assessment.
• Preferred: start-up experience.

Conditions

Compensation depends mainly on the job level the role is filled at and the candidate's qualifications, in line with applicable law.

The role may be filled at a different job level than listed, depending on business need and the selected candidate's experience, knowledge and skills.

Some roles may need proof of current vaccination, including COVID-19, depending on the customer and role.

Roles subject to export controls require an approved export license and/or a Technology Control Plan before the start date. Licensing can take 3 to 6+ months, and a Technology Control Plan typically adds 2 weeks.

Candidates with arrest and conviction records are considered under applicable fair chance laws.

Preference goes to qualified candidates who do not live, and do not plan to live, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina or Tennessee.