Product Development Engineer

Applied Medical • Rancho Santa Margarita, CA

14h

About The Position

Applied Medical is a medical device company that develops and manufactures advanced surgical technologies. The Product Development Engineer leads project workstreams across the full medical device development lifecycle, from early research through design transfer to manufacturing. Working closely with surgeons, the engineer defines user needs, develops and tests prototypes, and owns product design control and risk management documentation. The role is suited to an experienced medical device engineer who can own projects end to end, communicate across organizational levels, and mentor fellow engineers.

The position requires travel for regular surgeon visits and occasional hospital visits. The engineer observes live surgical procedures and completes hospital vendor credentialing when required.

Requirements

• Five or more years of hands-on engineering experience in medical device product development.
• Bachelor of Science in mechanical engineering or biomedical engineering, or a STEM degree from an ABET-accredited program.
• Demonstrated ownership of past engineering projects, with direct accountability for results beyond a support role.
• Ability to generate and review engineering documentation, including design controls, risk management files, test methods, reports, work instructions, and process validation.
• Comfort working in highly regulated environments.
• Ability to communicate and collaborate with team members at all organizational levels and across cross-functional departments.
• Ability to mentor and teach team members of all experience levels.
• Strong analytical, organizational, and critical thinking skills to solve complex engineering problems.

Nice To Haves

• Project management skills to lead workstreams and delegate tasks.

Responsibilities

• Lead project workstreams from concept through design transfer, adjusting focus to match each phase of development.
• Research new technologies, evaluate materials, and study surgical procedures alongside surgeons to define user needs.
• Develop prototypes, present them to surgeons, and refine designs and usability based on surgeon feedback.
• Create detailed product designs, test methods, and specifications, and update designs for manufacturability.
• Generate and review design control and risk management documentation, including test methods, reports, work instructions, and process validation.
• Participate in design verification and validation testing and support fixture, equipment, and tool design for manufacturing scale-up.
• Mentor engineers at all experience levels and share technical knowledge across the team.
• Collaborate with cross-functional engineering teams in brainstorming sessions and design reviews.
• Own projects end to end and deliver milestones on schedule.
• Translate surgeon needs into product designs ready for clinical use.
• Produce complete design control and risk management documentation to support regulatory compliance.
• Lead cross-functional initiatives through clear communication with partners at every organizational level.
• Travel for regular surgeon visits and occasional hospital visits; observe live surgical procedures and complete hospital vendor credentialing when required.

Benefits

• Competitive compensation range of $90,000–$140,000 per year in California; bonus and incentive compensation plans may apply.
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior