Project Engineer, Medical Devices Specialist

4 weeks ago


Marlborough, Massachusetts, United States Helen of Troy Full time
Job Summary

We are seeking a highly skilled Project Engineer to lead the development of consumer medical products. As a key member of our Engineering team, you will be responsible for designing, developing, and evaluating medical devices to ensure they meet regulatory requirements and customer needs.

Key Responsibilities
  • Lead technical product development teams to design, develop, and test medical devices.
  • Develop and maintain Design History Files (DHF) and technical documentation for medical products.
  • Collaborate with cross-functional teams, including engineering, marketing, and regulatory, to ensure compliance with regulatory requirements.
  • Conduct failure analysis and perform usability studies to identify areas for improvement.
  • Develop and support clinical studies and regulatory submissions, including 510K and CE registration filings.
  • Interface with external testing houses for compliance testing and validation.
Requirements
  • 3+ years of experience in product development, preferably in a regulated industry such as medical devices.
  • BS Degree in Biomedical, Mechanical, or Electrical Engineering or equivalent experience.
  • Strong knowledge of consumer product development processes and regulatory requirements.
  • Excellent communication and project management skills.
Preferred Qualifications
  • Master's Degree in a relevant field.
  • Hands-on experience with circuit design and PCBA design.
  • Understanding of UL/ETL/FDA/CE general requirements.
  • Ability to create data pipelines using programming languages such as MATLAB.
Benefits
  • Competitive salary and bonus structure.
  • Comprehensive benefits package, including healthcare, dental, and vision insurance.
  • 401(k) with company match.
  • Short-term and long-term disability insurance.
  • Paid time off and paid parental leave.
  • Opportunities for professional growth and development.


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