Program Manager - Medical Device at The Judge Group Inc. in Marlborough, Massachusetts

Job Description:

Location: Marlborough, MA

Salary: $175,000.00 USD Annually - $200,000.00 USD Annually

Description:
The Judge Group is seeking a Program Manager with extensive Class II Medical Device experience to join our client for a full time opportunity.



Title: Program Manager



Location: Marlborough, MA - Fully Onsite



Type: Full Time/Permanent



Must Have:

• Class II Medical Device, strong 13485 experience


• Experience in Program Management from conception to Manufacturing

Key Responsibilities

• Lead and manage cross-functional projects, coordinating with external resources and contracted companies.
  
  


• Develop and gain approval for detailed project plans in collaboration with senior management and stakeholders.
  
  


• Proactively identify and assess areas of risk, escalating issues promptly and proposing solutions.
  
  


• Partner with development team members to drive accountability and ensure high-quality project tasks and deliverables.
  
  


• Continuously prioritize team member activities and follow up on actions.
  
  


• Manage program budgets, generate forecasts, and track actuals against forecasts.
  
  


• Monitor project progress and implement corrective actions or contingencies as needed to meet commitments.
  
  


• Provide regular project status updates, variance analysis, and corrective action identification to management.
  
  


• Collaborate with functional management to secure resource commitments and resolve issues.
  
  


• Provide input on team member performance to directors, managers, and senior management, and effectively manage performance issues and conflicts.
  
  


• Oversee and facilitate compliance with design control and product development processes.
  
  


• Ensure project team activities and decisions are clearly communicated and documented.
  
  

Qualifications




Education:

• MS degree in an Engineering discipline or higher.
  
  

Skills:

• Advanced skills in project management, project reporting, and presentations.
  
  


• Excellent written and verbal communication skills.
  
  

Experience:

• 5+ years of project management experience with complex laser-based systems.
  
  


• 10+ years of technology development experience in one of the following areas: laser systems, electro-opto-mechanical systems, or optics-based medical devices.
  
  


• Proven track record of executing complex multi-functional projects on time and within budget.
  
  


• Ability to manage multiple projects in a fast-paced development environment.
  
  


• Proven experience working within controlled product development processes.
  
  


• Preferred knowledge of Design Controls and Risk Management practices, regulations, and standards, such as FDA QSRs, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825, and 62366.
  
  

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Contact: amassad@judge.com


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