Program Manager / Senior Project Manager – Combination Devices & NPI

Program Manager / Senior Project Manager – Combination Devices & NPI
Rate: $110-115/HR based on benefits
Contract Length: 2 Years
Location: Onsite-Branchburg, NJ
Schedule: M-F Standard Business Hours
 
Orion Group is seeking a highly experienced Program Manager / Senior Project Manager to support our pharmaceutical client’s Combination Device organization in Branchburg, NJ. This role will enable the commercialization of New Product Introductions (NPIs), manage portfolios of on-market support projects, and provide project management leadership across Product Development, Supply Chain, Quality, Regulatory, Engineering, Manufacturing, and Commercial teams.
This position leads NPI programs from R&D handoff through final launch, serving as a commercial liaison while driving cross-functional integration to deliver compliant, high-quality, cost-effective products. The role also supports strategic product sustainment initiatives to ensure supply robustness, customer satisfaction, and operational excellence.
 
Primary Responsibilities

• Develop bottom-up, cross-functional project and program plans spanning R&D, Engineering, Manufacturing, Quality, Regulatory, Supply Chain, and Commercial.
• Lead global project teams across Product Development Science & Technology (PDS&T), franchise organizations, and third-party suppliers.
• Manage execution of NPIs, technical transfers, product maintenance initiatives, and global launches of combination devices.
• Create and maintain detailed project artifacts including:
  • Microsoft Project schedules
  • Office Timeline Plus summaries
  • Action Logs, Risk Logs, Decision Logs, and RACI matrices
• Own project budgets, timelines, milestones, and reporting cadence.
• Identify risks, implement corrective actions, and recommend value-added alternatives to ensure milestone achievement.
• Provide project management oversight to external vendors, suppliers, and contractors.
• Facilitate cross-functional communication and resolve technical, financial, and resource conflicts.
• Drive continuous improvement initiatives using Lean methodologies.
• Support development and maturation of Program Management processes within the PDS&T organization.
• Maintain executive visibility through structured reporting and governance models.
• Lead initiatives across multiple time zones and support both remote and onsite teams.

 
Key Deliverables

• Integrated program execution from development through commercialization
• Robust project governance and escalation
• Budget and milestone adherence
• Continuous process improvement
• High-quality product launches and sustained product performance

 
Required Qualifications

• Bachelor’s degree in Engineering, Science, or related discipline
• 10–15 years of experience within medical device and pharmaceutical environments (combination products strongly preferred)
• PMI certification (highly desirable)
• Lean Six Sigma Green Belt or Black Belt with significant facilitation/workshop experience
• Extensive experience in operations and device product development
• Advanced proficiency in Microsoft Office and Microsoft Project
• Demonstrated program management expertise across global organizations

Preferred

• Advanced business degree (MBA or equivalent)
• Experience with technical transfers, supply chain, validations, and commercial product launches

 
Technical & Business Knowledge

• Strong understanding of R&D practices and design controls
• Medical device/pharma regulatory environment
• Capital and expense management
• Global logistics and product movement
• Project management tools and methodologies

 
Leadership Competencies

• Strategic thinker with strong change leadership capability
• Proven ability to influence cross-functional stakeholders
• Results-oriented with a strong sense of urgency
• Comfortable operating in complex global environments
• Effective communicator across all organizational levels
• Team builder who inspires performance and accountability

 
Environmental Health & Safety (EHS)

• Adhere to all EHS policies and procedures
• Report incidents and near misses through eAchieve
• Participate in required safety training and medical surveillance
• Promote EHS best practices and continuous improvement
• Wear PPE as required

 
Accountability & Scope

• Establish project timelines, priorities, and performance metrics
• Assign and manage resources
• Track progress and financial commitments
• Identify improvement opportunities aligned with organizational strategy
• Ensure delivery against capital and expense targets

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.