Medical Device Compliance Documentation Engineer

Applied Medical Corporation; Rancho Santa Margarita (CA); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Mentorship program

Wellness activities on campus

Medical, dental and vision coverage

Education reimbursement

401(k) with employer match

Vacation accrual and paid holidays

Job summary

Applied Medical Corporation in California seeks a Compliance Documentation Engineer to develop, review, and maintain technical documentation for medical device compliance across product lifecycles.

You will collaborate with Quality, Regulatory Affairs, Clinical Affairs, Manufacturing and Engineering teams to support design controls, risk management and regulatory submissions, ensuring alignment with IEC 60601, ISO 13485, RoHS and REACH standards.

Qualifications

• Bachelor's degree required in Engineering or related 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

Responsibilities

• 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), and regulatory/standards compliance assessments.
• Review applicable standards and regulations and document changes impacting device compliance.
• Partner 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.

Skills

Technical writing

Regulatory compliance

Cross-functional collaboration

Project management

Attention to detail

Education

Bachelor's degree in Engineering or related field

Tools

PTC

Jama

Job description

Applied Medical Corporation in California seeks a Compliance Documentation Engineer to develop, review, and maintain technical documentation for medical device compliance across product lifecycles.

You will collaborate with Quality, Regulatory Affairs, Clinical Affairs, Manufacturing and Engineering teams to support design controls, risk management and regulatory submissions, ensuring alignment with IEC 60601, ISO 13485, RoHS and REACH standards.