Product Development Engineer

Applied Medical; Rancho Santa Margarita (CA); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Competitive pay

Benefits package

Mentorship opportunities

Wellness activities

Education reimbursement

401(k) match

Job summary

Applied Medical is a leading medical device company hiring a Product Development Engineer in California. The role leads cross-functional projects from initial concept through design transfer to manufacturing, partnering with surgeons to define needs and validate prototypes.

Travel to surgeons and hospital visits are required to support credentialing and implementation. The engineer will own design control and risk management documentation, mentor peers, and drive development across the full

Qualifications

• Five or more years of hands-on engineering experience in medical device product development.
• Clear ownership of past engineering projects with direct accountability for results.
• Experience in highly regulated environments and generating engineering documentation.
• Ability to communicate and collaborate across all organizational levels.

Responsibilities

• Lead project workstreams from concept through design transfer and manufacturing.
• Research technologies, evaluate materials, and study procedures with surgeons to define user needs.
• Develop prototypes, present to surgeons, and refine designs based on feedback.
• Create detailed product designs, test methods, and specifications for manufacturability.
• Generate and review design control and risk management documentation.
• Participate in design verification/validation and support manufacturing scale-up.

Education

BS in Mechanical or Biomedical Engineering, ABET-accredited

Job description

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

Position Description

The Product Development Engineer leads project workstreams across the full medical device development lifecycle at Applied Medical, from early research through design transfer to manufacturing. Partnering closely with surgeons, the Product Development Engineer defines user needs, develops and tests prototypes, and owns the design control and risk management documentation behind each product. This research and development (R&D) engineer role fits an experienced medical device engineer who owns projects end to end, communicates across all organizational levels, and mentors fellow engineers.

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

Key Responsibilities

• Lead project workstreams from concept through design transfer, adjusting focus to match each phase of development.
• Research new technologies, evaluaate 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.

Success in This Role Looks Like

• Owning projects end to end and delivering milestones on schedule.
• Translating surgeon needs into product designs ready for clinical use.
• Producing complete design control and risk management documentation to support regulatory compliance.
• Developing team members through consistent mentoring and knowledge sharing.
• Leading cross-functional initiatives through clear communication with partners at every organizational level.

Position Requirements

This position requires the following skills and attributes:

• Bring five or more years of hands-on engineering experience in medical device product development.
• Hold a Bachelor of Science (BS) in mechanical engineering or biomedical engineering, or a science, technology, engineering, and mathematics (STEM) degree from an ABET-accredited program.
• Demonstrate clear ownership of past engineering projects, with direct accountability for results beyond a support role.
• Generate and review engineering documentation, including design controls, risk management files, test methods, reports, work instructions, and process validation.
• Work comfortably in highly regulated environments.
• Communicate and collaborate with team members at all organizational levels and across cross-functional departments.
• Mentor and teach team members of all experience levels.
• Solve complex engineering problems through strong analytical, organizational, and critical thinking skills.

Preferred

• Apply project management skills to lead workstreams and delegate tasks.

Benefits

• Competitive compensation range: $90000 - $140000 / year (California).
• 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.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

All compensation and benefits are subject to plan documents and written agreements.

Equal Opportunity Employer

Applied Medical is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other basis protected by federal, state or local laws in the locations where Applied Medical operates.