Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position Overview: We are seeking an experienced and dynamic R&D Project Manager to lead the development of ground breaking medical devices within the clinical applications space. The ideal candidate will have a strong background in medical device / IVDR project management, an understanding of mass spectrometry and liquid chromatography, and experience with software integration. This role requires a strategic problem solver with excellent leadership skills to drive complex projects from conception to market.

Key Responsibilities:

Project Leadership:

Lead cross-functional teams in the planning, execution, and delivery of medical device development projects.Define project scope, goals, and deliverables in collaboration with senior management and partners.Develop detailed project plans, schedules, and budgets, ensuring alignment with organizational objectives.

Partner Management:

Serve as the main contact for all project-related communications.Collaborate with internal and external partners, including R&D, engineering, regulatory affairs, quality assurance, marketing, and clinical teams.Facilitate regular project meetings and provide updates to partners on project status, risks, and issues.

Technical Expertise:

Working with scientific authorities, guide project teams to ensure technical excellence.Oversee the integration of software solutions with hardware components, ensuring seamless functionality and user experience.Stay current with industry trends, standard processes, and regulatory requirements related to medical device development.

Risk Management:

Identify potential project risks and develop mitigation strategies.Monitor project progress and implement corrective actions as necessary to ensure successful project outcomes.Ensure compliance with all relevant regulatory standards and quality systems.

Resource Management:

Allocate and lead project resources effectively, including personnel, budget, and equipment.Champion a collaborative and high-performance team environment, providing mentorship and support to team members.

Documentation and Reporting:

Maintain comprehensive project documentation, including project plans, status reports, and technical specifications.Prepare and present project reports to senior management and partners.Ensure all project documentation is follows regulatory and quality standards.

Qualifications:

Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree preferred.Minimum of 8-10 years of project management experience in the medical device or related industry.Proven track record of successfully leading complex development projects.Strong understanding of regulatory requirements and quality systems for medical device development (e.g., FDA, ISO).Exceptional leadership, communication, and interpersonal skills.Proficiency in project management software and tools (e.g., MS Project, Smartsheet).PMP certification or equivalent is highly desirable.Ability to work in a fast-paced, matrixed environment while leading multiple priorities.

Compensation and Benefits

The salary range estimated for this position based in California is $129,400.00–$194,050.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards