Project Manager Combination Devices & NPI

Program Manager / Senior Project Manager – Combination Devices & NPI

Pay Rate: $84-$89/HR based on benefits
Contract Length: 12 Months to start
Location: Hybrid – Tuesday, Wednesday, Thursday onsite; Monday & Friday remote (per company policy)
 
Orion Group is seeking an experienced Program Manager / Senior Project Manager to support Combination Device and Device programs within a global Product Development, Supply & Technology (PDS&T) organization.
This role enables the commercialization of New Product Introductions (NPIs), manages on-market product support portfolios, and provides project management leadership across R&D, Engineering, Manufacturing, Quality, Regulatory, Supply Chain, and Commercial teams.
The successful candidate will lead programs from R&D handover through final launch and commercialization while ensuring compliance with design controls, regulatory requirements, and supply robustness.
 
Top Required Skills

1. Advanced Microsoft Project proficiency – Expertise in planning, scheduling, resource management, tracking milestones, and driving on-time delivery.
2. Strong Communication Skills – Clear, concise verbal and written communication across all organizational levels and global stakeholders.
3. Conflict Management – Ability to proactively identify, address, and resolve cross-functional conflicts while maintaining alignment to project goals.
4. Cross-Functional Leadership – Proven experience leading diverse global teams to successful execution.
5. Design Controls Expertise – Deep understanding of medical device and combination product design control processes and regulatory requirements.

 
Key Responsibilities
Program & NPI Leadership

• Lead NPI programs from R&D handover through commercialization.
• Coordinate global project teams across PDS&T, Franchise, and Third-Party Suppliers.
• Manage technical transfers, product maintenance initiatives, and global launches.
• Ensure compliance with design controls and regulatory standards throughout lifecycle.

Portfolio & On-Market Support

• Lead strategic product support programs to ensure supply robustness, product quality, and customer service excellence.
• Balance cost, risk, compliance, and benefit optimization.
• Integrate change management and recommend value-added alternatives.

Project Execution & Governance

• Develop realistic cross-functional project implementation plans (R&D, Engineering, Manufacturing, Quality, Regulatory, Commercial).
• Utilize project management tools to plan, monitor, and report progress.
• Manage budgets, timelines, capital and expense commitments.
• Establish milestones and take corrective action to maintain schedule adherence.
• Escalate risks appropriately using governance models.
• Provide structured updates to upper management.

Cross-Functional & External Collaboration

• Guide vendors, suppliers, and contractors toward shared milestone achievement.
• Facilitate communication across global teams and time zones.
• Lead conflict resolution across technical, financial, and business stakeholders.

Process Improvement

• Identify and implement process improvements.
• Support development and maturation of Program Management processes within the organization.
• Drive efficiency initiatives to improve quality, compliance, cost-effectiveness, and timeliness.

 
Education & Certifications

• Bachelor’s Degree in Engineering, Science, or related discipline required.
• An advanced business degree is preferred.
• PMP certification highly desirable.
• Lean Six Sigma Green Belt or Black Belt preferred.

 
Required Experience

• 10+ years of diversified business experience.
• 5+ years in medical device, pharmaceutical, or combination products.
• Experience in:
  • Operations support and plant-level quality
  • Supply chain and product transfers
  • Validations (IQ/OQ/PQ)
  • Capital and expense management
  • Commercial product launches
• Strong knowledge of:
  • Design Controls
  • Medical device regulations
  • Combination product lifecycle
• Advanced proficiency in Microsoft Project and Microsoft Office Suite.

 
Leadership & Behavioral Expectations
The successful candidate will:

• Think strategically while executing tactically.
• Establish credibility across all levels of the organization.
• Drive change and influence without direct authority.
• Deliver results with minimal supervision.
• Inspire cross-functional teams.
• Build consensus and manage global stakeholders.
• Act with urgency and decisiveness.

 
Environmental, Health & Safety (EHS)

• Comply with all EHS policies and procedures.
• Maintain safe work practices.
• Report incidents and support continuous safety improvement.
• Complete required training and wear appropriate PPE.

 
Scope & Accountability

• Establish timelines and priorities.
• Assign and manage resources effectively.
• Track and measure performance accurately.
• Ensure achievement of capital and expense commitments.
• Drive process redesign initiatives to improve operational efficiency.

People are our business worldwide
 
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.