Project Manager III (non-IT)

Project Manager III (non-IT)
2-yr contract
Irvine, CA
Hybrid Schedule
9am-5 pm
$100/HR

Orion Group is seeking a Project Manager III for combination products development, who will be 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.) for our pharmaceutical client in Irvine, CA.
 
The Project Manager will ensure 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.

The Project Manager will be accountable to the Program Manager Director for delivering on the strategy, plans, and budget defined for the project portfolio.

Responsibilities include:

• 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
• 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.

 
Project Manager III Qualifications
 

• Bachelor’s degree in engineering (mechanical or biomedical engineering). A 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.
• 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.
  

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.