Biomedical Systems Engineer – Regulated Medical Devices

Mainstay Medical; San Diego (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Equity in the company

Comprehensive retirement plan

Job summary

A leading medical device company seeks a Systems Engineer to join its product development team in San Diego. The role involves collaboration across engineering disciplines and requires at least 3 years of experience in a regulated environment. Responsibilities include supporting product development phases, managing requirements, and ensuring compliance with FDA guidelines. A Bachelor's degree in a relevant field is required, with a salary range of $90,000 to $120,000 per year, alongside a comprehensive benefits package.

Qualifications

• 3+ years experience as a Systems Engineer in a regulated environment.
• Ability to work cohesively with cross-functional teams.
• Familiarity with FDA design controls and risk management processes.

Responsibilities

• Support project execution through product development life cycle.
• Translate stakeholder needs into formal requirements.
• Lead design reviews and verification/validation activities.

Skills

Team collaboration

Communication skills

Risk management

Technical documentation

Systems thinking

Education

Bachelor's degree in Biomedical or related field

Tools

FDA design controls

ISO 14971

Programming languages (Python, Matlab)

Job description

A leading medical device company seeks a Systems Engineer to join its product development team in San Diego. The role involves collaboration across engineering disciplines and requires at least 3 years of experience in a regulated environment. Responsibilities include supporting product development phases, managing requirements, and ensuring compliance with FDA guidelines. A Bachelor's degree in a relevant field is required, with a salary range of $90,000 to $120,000 per year, alongside a comprehensive benefits package.