SPECTRAFORCE · 4 hours ago
Project Manager [Combinational Product Development]
Irvine, CA
Contract
Onsite
Senior Level, Lead/Staff
8+ years expSPECTRAFORCE is seeking a Project Manager for Combination Products Development. The role involves leading a cross-functional team to execute a portfolio of projects focused on drug delivery systems, ensuring alignment with patient needs and business objectives.
ConsultingCRMInformation TechnologyLegal
Hiring Manager
Naina Rathi
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
Required
Bachelor's degree in engineering (mechanical or biomedical engineering)
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
Ability to motivate teams, delegate tasks effectively, and drive project success
Excellent written and verbal communication skills to manage stakeholders and team members
Expertise in identifying, assessing, and mitigating project risks
Proficiency in planning, prioritizing tasks, managing timelines, and using project management tools
Strong analytical skills to resolve issues and adapt to changing project requirements
In-depth understanding of the pharmaceutical and device product development cycle
Design history file, project management and product development experience is essential
Preferred
Master's degree in engineering or management
Project Management Professional (PMP) Certification
Company
SPECTRAFORCE
Welcome to SPECTRAFORCE, your gateway to NEWJOBPHORIA™! Established in 2004, SPECTRAFORCE is now one of the largest and fastest growing U.S.
1001-5000 employees
H1B Sponsorship
SPECTRAFORCE has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
2022 (6)
2021 (8)
2020 (7)
Funding
Current Stage
Late StageCompany data provided by crunchbase