Summary

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.

Job description

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, 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.

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

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.

Requirements

Five or more years of hands-on engineering experience in medical device product development
Bachelor of Science (BS) in mechanical engineering or biomedical engineering, or a STEM degree from an ABET-accredited program
Demonstrate clear ownership of past engineering projects with direct accountability 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

Benefits

Comprehensive benefits package
Training and mentorship opportunities
On-campus wellness activities
Education reimbursement program
401(k) with discretionary match
Generous vacation accrual
Paid holiday schedule

Company overview

Applied Medical Deutschland GmbH is the German subsidiary of Applied Medical, a global medical device company founded in 1987 and headquartered in Southern California. As part of a vertically integrated organization with approximately 5,000 team members worldwide, the German operation serves as a key distribution hub for the European market. The company specializes in manufacturing and distributing innovative surgical devices for minimally invasive and general surgery across multiple medical specialties including cardiac, vascular, urologic, colorectal, bariatric, obstetric, and gynecologic procedures. Applied Medical operates with a unique business model focused on three fundamental healthcare needs: enhanced clinical outcomes, cost containment, and unrestricted choice. With European headquarters in Amersfoort, Netherlands and German operations in Düsseldorf and Bonn, the company maintains a strong presence in Germany's healthcare sector. Applied Medical dedicates approximately 20% of its annual revenue to product development and manufacturing efficiency projects, fueling continuous innovation in surgical technologies. The company's product portfolio includes advanced access platforms, laparoscopic systems, electrosurgical instruments, and specialized surgical devices designed to improve patient outcomes while addressing healthcare economic challenges.