Project Manager- Combination Products Development

Project Manager III – Combination Products Development (Non-IT)
Location: Irvine, CA
Work Schedule: Hybrid (Monday & Friday Remote / Tuesday–Thursday Onsite)– Non-negotiable
Hours: Monday–Friday, 9:00 AM – 5:00 PM
Pay Rate: $95–$98/hour (based on benefits selection)
Contract Length: 2 years (extension based on performance and business needs)


Orion Group is seeking a Project Manager III – Combination Products Development to lead a portfolio of drug delivery system development programs supporting our pharmaceutical client’s combination products.
This role is accountable for driving cross-functional execution across Engineering, Quality, Supply Chain, Operations, Human Factors, Marketing, and external device partners to deliver patient-focused, compliant, and high-quality delivery system solutions aligned with clinical and CMC milestones.

The Project Manager will partner closely with Program Leadership to ensure development strategy, timing, scope, and budget align with business objectives and regulatory expectations across all phases of development.

Key Responsibilities

• Lead a portfolio of drug delivery system development projects, including devices, accessories, and Instructions for Use (IFUs)
• Drive cross-functional collaboration across Engineering, Quality, Supply Chain, Operations, Human Factors, Marketing, and external partners
• Own project execution, timelines, scope, and budget, ensuring alignment with CMC gate reviews and clinical phase needs
• Manage external device development partners, including governance, performance oversight, and forward-looking partner evaluation
• Provide device financial management, including budgeting, forecasting, and long-range planning of development expenses
• Identify, assess, and proactively mitigate project risks, ensuring delivery against milestones
• Represent R&D to cross-functional and senior leadership through clear, timely, and effective communication
• Ensure disciplined project management practices, including:
  • Clearly defined objectives and agendas
  • Effective meeting facilitation
  • Accurate documentation, action tracking, and follow-through
• Maintain and support Design History Files (DHF) and ensure compliance with design controls and development processes
• Support continuous improvement initiatives to enhance execution efficiency and adaptability

Required Qualifications

• Bachelor’s degree in Engineering (Mechanical or Biomedical Engineering required)
• 8+ years of experience in the medical device and/or combination product industry
• Demonstrated experience with:
  • Combination product or medical device development
  • Design controls
  • Human factors and usability studies
  • Design verification and validation
• Strong understanding of the pharmaceutical and medical device product development lifecycle
• Proven experience managing Design History Files (DHF)

Preferred Qualifications

• Master’s degree in Engineering or Management
• Project Management Professional (PMP) certification

Core Skills & Competencies

• Leadership: Ability to motivate teams, delegate effectively, and drive results across complex programs
• Communication: Strong written and verbal skills to engage stakeholders at all levels
• Risk Management: Expertise in identifying, assessing, and mitigating project risks
• Scheduling & Organization: Advanced planning, prioritization, and timeline management skills using project management tools
• Problem-Solving & Process Improvement: Analytical mindset with the ability to adapt to changing project needs in a regulated environment

Why This Role
This is a high-visibility opportunity to support a combination product portfolio, working at the intersection of device innovation, pharmaceutical development, and patient-centric design. The role offers long-term stability, complex technical challenges, and strong cross-functional exposure within a leading biopharmaceutical organization.
 


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.