Compliance Documentation Engineer I​/II

As a new generation medical device company, Applied Medical is equally committed to improving the accessibility and affordability of high-quality healthcare globally. We achieve this through a vertically integrated business model that enables our team members to develop technologies that enhance clinical care, while offering boundless opportunities for professional growth.

Collaboration is a fundamental part of our organization's culture and is essential to our continued success. As such, the successful candidate for this position is expected to work on-site, enabling them to engage fully with colleagues and contribute to cross-functional initiatives. Therefore, the ability to work collaboratively and contribute to a positive and supportive team environment is a key requirement for this role.

The Compliance Documentation Engineer plays a key role in supporting medical device compliance through the development, review, and maintenance of technical documentation. This position works closely with Quality, Regulatory Affairs, Clinical Affairs, and Engineering teams to ensure products meet internal requirements, regulatory standards, and industry best practices throughout the product lifecycle.

This is a highly collaborative and documentation-focused role requiring strong technical writing, attention to detail, and the ability to manage compliance-related activities across multiple projects.

• Develop, review, and maintain compliance documentation, including:
  • Design control documentation
  • Engineering test protocols and reports
  • Manufacturing instructions and test methods
  • Risk management documentation (FMEA, hazard analyses)
  • Regulatory and standards compliance assessments
• Ensure documentation is complete, accurate, and aligned with internal procedures and regulatory requirements.
• Review applicable standards and regulations and document changes impacting device compliance.

• Partner closely with Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, and Engineering teams to support product development and compliance activities.
• Coordinate documentation and compliance deliverables to support project timelines and regulatory submissions.
• Participate in design reviews and help ensure design controls and risk management activities remain aligned throughout development.

• Support device verification and validation activities and document test results.
• Assist in the development and maintenance of risk management documentation, including FMEAs and hazard analyses.
• Support compliance assessments against applicable medical device standards and regulations.

• Evaluate product compliance with applicable standards and regulations, including:
  • IEC 60601
  • ISO 13485
  • RoHS
  • REACH
• Support certification testing activities and interactions with external testing and certifying bodies such as UL.
• Monitor changes to standards and regulatory requirements and assess potential impacts on products and documentation.

Position Requirements:

• Bachelor’s degree in Engineering or a related technical field.
• 1+ years of relevant experience in engineering, quality, regulatory, compliance, or medical device environments.
• Strong technical writing and documentation skills.
• Ability to interpret technical standards, procedures, drawings, protocols, and regulations.
• Strong organizational, analytical, and project management skills.
• Effective verbal and written communication skills.
• Ability to work independently while collaborating effectively across cross-functional team

Preferred Requirements:

• Experience with medical device design controls, risk management, and verification/validation…