Project Manager – Medical Devices | Brooksville, Florida
Direct Hire | Onsite
 
Targeted salary range: $95,000-115,000 depending upon qualification
 
Kelly Engineering seeks a skilled Project Manager to join our client’s team. In this role, they will lead cross-functional teams responsible for the development, industrialization, and lifecycle management of electromechanical medical device components and assemblies.

What You’ll Need:

• Familiarity with ISO 13485 quality systems.
  

• Familiarity with product development and manufacturing processes.
  

• Bachelor’s degree in engineering (Mechanical, Electrical, or related field) or equivalent experience.
  

• 5 years experience in medical device manufacturing environment
  

• Understanding of regulated product development environments.
  

• Ability to interpret technical documentation, drawings, and specifications.
  

• Experience managing complex engineering or manufacturing programs.
  

• Experience coordinating cross-functional teams including engineering, manufacturing, and quality.

Essential Job Functions:

• Lead cross-functional teams in product development and manufacturing programs.
  

• Develop and maintain detailed program schedules and deliverables.
  

• Align engineering, customer, and manufacturing requirements within program plans.
  

• Track program status, risks, and deliverables to meet objectives.
  

• Facilitate leadership and stakeholder program reviews.
  

• Coordinate all product design and development activities, including inputs, reviews, V&V, and risk management.
  

• Monitor engineering team progress and ensure completion of required design documentation.
  

• Manage Design History Files (DHF) and ensure design records are organized and audit-ready.
  

• Maintain and oversee program risk register; track and escalate critical risks.
  

• Lead design transfer and manufacturing readiness activities, including validation and documentation.
  

• Conduct readiness reviews to confirm all elements are in place for production release.
  

• Monitor early-stage production, track performance metrics, and coordinate resolution of manufacturing issues.
  

• Ensure adherence to Quality Management System and facilitate compliance activities (risk management, CAPA, audits).
  

• Serve as the primary program contact for customer communications and technical reviews.

Benefits

• Medical, dental, vision insurance
  

• Bonus program
  

• PTO
  

• 401k

All applicants applying for this job opening must be legally authorized to work in the United States and are required to have US residency at the time of application. Sponsorship is not available for this opportunity. OPT or H1B Visa is not being accepted at this time.

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