Project Manager

Position Title: Project Manager

Work Location: Irvine CA

Duration: 24 Months

Position Summary:

The Project Manager, Combination Products Development is accountable for leading the cross functional team (Engineering, Quality, Supply Chain, Marketing, Operations, Human Factors, and External Partners) in the execution of a portfolio of projects focused on the delivery system constituent parts of a combination product (Devices, Accessories, Instructions for Use, etc.).

The Project Manager ensures that the strategy and plans defined for assigned programs are aligned with the needs of the patient and customer and the business objectives of the CMC and Product Strategy teams. In addition, product development timing and scope need to support plans for CMC gate reviews and each clinical phase.

Background & Context: To transition the current contractor role ahead of the contract's scheduled expiration in early 2026.

Key Responsibilities:

• The Project Manager will be accountable to the Program Manager Director for delivering on the strategy, plans and budget defined for the project portfolio.
• Leadership of a portfolio of drug delivery system product development projects
• Tactical and strategic management of external device partners including acting as a key interface, managing the project governance process and forward-looking evaluation of potential partners
• Device financial management including budgeting, forecasting and long-range planning of delivery development expenses
• Representing the R&D organization to cross functional leadership through effective and timely communication
• Ensuring effective use of meetings by clearly defining objectives, agendas, inviting the team members specifically needed and publishing minutes and actions
• Qualification & Experience:
• Required: Bachelor's degree in engineering (mechanical or biomedical engineering). Master's degree in engineering or management is preferred but not required.
• Certification: Project Management Professional (PMP) Certification preferred, but not required
• 8+ years of experience in the combination product or medical device industry with proven experience in developing medical devices or combination products; broad experience in design controls, human factors studies, design verification/validation and usability studies.

Required Skills:

• Leadership: Ability to motivate teams, delegate tasks effectively, and drive project success.
• Communication: Excellent written and verbal communication skills to manage stakeholders and team members.
• Risk Management: Expertise in identifying, assessing, and mitigating project risks.
• Scheduling & Organization: Proficiency in planning, prioritizing tasks, managing timelines, and using project management tools.
• Problem-Solving/Process Improvement: Strong analytical skills to resolve issues and adapt to changing project requirements.
• Requires an in-depth understanding of the pharmaceutical and device product development cycle.
• Design history file, project management and product development experience is essential.