Project Manager III (Design Engineer)

Project Manager, Combination Products Development

Join our team as a Project Manager for Combination Products Development, where you will lead a cross-functional team in the execution of a portfolio of projects focused on the delivery system constituent parts of a combination product. This role is essential in ensuring that the strategy and plans defined for assigned programs align with the needs of the patient and customer, as well as the business objectives of the CMC and Product Strategy teams.

Job Description

• Lead a portfolio of drug delivery system product development projects.
• Manage external device partners, acting as a key interface and overseeing the project governance process.
• Handle device financial management, including budgeting, forecasting, and long-range planning of delivery development expenses.
• Represent the R&D organization to cross-functional leadership through effective and timely communication.
• Ensure effective use of meetings by clearly defining objectives, agendas, inviting necessary team members, and publishing minutes and actions.

Requirements

• Bachelor's degree in engineering (mechanical or biomedical engineering).
• Preferred: Master's degree in engineering or management.
• 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.

About US Tech Solutions

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.