Medical Device Compliance Documentation Engineer

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

Benefits offered by this job

Mentorship

Wellness activities

Medical coverage

Dental coverage

Vision coverage

Education reimbursement

401(k) with match

Vacation & holidays

Job summary

Applied Medical in California is seeking a Compliance Documentation Engineer to develop, review, and maintain technical documentation for medical device compliance throughout the product lifecycle. This role collaborates with Quality, Regulatory Affairs, Clinical Affairs, and Engineering to ensure alignment with internal procedures and regulatory standards.

You will prepare design controls, risk management documents (FMEA), test protocols, and regulatory assessments while maintaining

Qualifications

• Bachelor’s degree in Engineering or a related technical field is required.
• 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 teams.

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 assessments.
• Coordinate documentation and compliance deliverables with Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, and Engineering teams to support product development and regulatory submissions.
• Support device verification and validation activities and document test results; assist in risk management documentation and regulatory compliance activities.
• Evaluate product compliance with IEC 60601, ISO 13485, RoHS, and REACH; monitor changes to standards and regulatory requirements and assess impacts on products and documentation.

Skills

Technical writing

Documentation

Regulatory interpretation

Communication

Project management

Analytical thinking

Team collaboration

Education

Bachelor’s degree in Engineering or related field

Tools

PTC

Jama

Job description

Applied Medical in California is seeking a Compliance Documentation Engineer to develop, review, and maintain technical documentation for medical device compliance throughout the product lifecycle. This role collaborates with Quality, Regulatory Affairs, Clinical Affairs, and Engineering to ensure alignment with internal procedures and regulatory standards.

You will prepare design controls, risk management documents (FMEA), test protocols, and regulatory assessments while maintaining