Responsibilities:

• Plan, execute, and manage V&V testing campaigns to support regulatory submissions.
• Draft test protocols and reports according to FDA and ISO guidelines.
• Oversee outsourced testing, including biocompatibility and animal studies.
• Facilitate risk management and design requirements procedures as needed.
• Assist in troubleshooting and system improvement efforts.
• Provide support for production processes.

Qualifications:

• Bachelor’s degree in Mechanical or Biomedical Engineering.
• Strong English language skills (reading, writing, speaking).
• Experience with medical device testing requirements, including QA procedures and standards.
• 3+ years of experience in a medical device company.
• Ability to work independently and collaborate effectively with teams.