Staff Project Engineer

2 weeks ago


Mounds View, Minnesota, United States Cypress HCM Full time

Senior Project Engineer – Medical Devices

Role Overview: This position may also be filled as a Lead Project Engineer or Staff Project Engineer.

Work Arrangement: Hybrid model, requiring in-office presence three days a week.

Company Size: Global workforce of approximately 13,000 employees.

Team Dynamics: Join a dedicated team of 50 professionals in the health and safety, scientific, consumer services, and medical devices sectors.

Financial Overview: Company revenue exceeds $2 billion. Reporting Structure: Directly reports to the Operations Manager. Travel Requirements: Minimal travel, around 10%.

Key Responsibilities:

  • Manage and execute safety investigations for innovative medical devices.
  • Coordinate, oversee, and assess intricate laboratory operations for team members.
  • Provide training and mentorship to junior laboratory personnel and entry-level engineers.
  • Evaluate samples to ensure compliance with safety standards in the laboratory environment.
  • Communicate project updates and findings to clients through regular interactions and reports.
  • Analyze project requirements, establish specifications, and develop testing protocols.
  • Conduct quality systems and technical audits of client laboratories as necessary.
  • Implement continuous improvement methodologies and practices.
  • Address engineering challenges related to variation notices.
  • Support the formulation of requirements, specialized testing methods, and testing equipment.

Qualifications:

  • A minimum of 5 years' experience in compliance engineering.
  • Proven experience as an Evaluator and Reviewer in core standards such as IEC.
  • Additional experience with Evaluator and Reviewer roles in the 60601 series standards.
  • A Bachelor's degree in electrical engineering, biomedical engineering, or a related discipline is preferred.
  • Fundamental understanding of laboratory testing equipment and methodologies for medical devices.
  • Proven ability to lead in a technical setting and deliver innovative solutions to complex challenges.
  • Excellent communication skills with the ability to engage effectively with clients.
  • Experience in testing electrical and connected medical device products, including patient monitors, robotic surgical systems, infusion pumps, and more.

Compensation Package:

  • Salary range: $130K - $180K, plus performance-based bonuses.


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