Project Manager, Private Labeling

4 weeks ago

Coral Springs, Florida, United States LifeSync Full time
Job Summary

LifeSync is seeking a highly skilled Project Manager, Private Labeling to drive the qualification and private labeling of specialized and/or niche 3rd party products into our product portfolio.

The successful candidate will work closely with other functions, especially Product Management, Supply Chain, Quality and Regulatory, and external supplier teams to identify potential sources of high-quality products, document specifications, perform product testing to internal and external standards, and create/updating processes.

Key Responsibilities:

  • Provide project leadership for the commercialization of private labeled medical devices, demonstrating hands-on responsibility for the creation of specifications and product qualification documentation.
  • Collaborate with Product Management, Supply Chain, Quality and Regulatory to understand project requirements, identify candidate products, create specification requirements, execute qualification plans, and document test results.
  • Create plans and schedules with milestones for execution tracking.
  • Work with external supplier teams to implement customized private labeling requirements.
  • Analyze applicable medical device standards and translate into purchasing specifications and/or test requirements, as applicable.
  • Support customer complaint investigations requiring engineering expertise.
  • Support CAPA activities, performing robust root cause analysis and implementation of corrective and preventive actions.

Requirements:

  • Proficient in understanding technical drawings and specifications, including mechanical and electrical requirements and material properties.
  • Skilled in the creation of technical documentation.
  • Ability to read and interpret technical standards, write product specifications, test protocols, and reports.
  • Structured and disciplined, with a strong focus on execution.
  • Preferred - knowledgeable in the quality system requirements of ISO13485:2016 and FDA 21 CFR QSR Part 820.
  • Proficient with Microsoft tools; Word, Excel, PowerPoint, MS Project (desired).
  • Excellent communication skills, and ability to gain buy-in to concepts and ideas.

Education and Experience:

  • Bachelor's degree in mechanical engineering, Electrical engineering, Biomedical Engineering, or similar related discipline.
  • 2 years engineering experience (medical Devices or similar regulated industry preferred).

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