Design Engineer

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

Benefits offered by this job

Competitive compensation range

Comprehensive benefits package

Training and mentorship opportunities

On-campus wellness activities

Education reimbursement

401(k) with employer match

Generous vacation accrual and holidays

Job summary

Applied Medical seeks a Design Engineer to create medical devices and fixtures, prototype parts, and drive production‑ready designs with complete documentation. You will work across development phases, study surgical procedures, and translate surgeon feedback into engineering requirements.

The role requires CAD proficiency (Creo/SolidWorks), application of GD&T, and participation in IQ/VV testing, with travel to surgeon sites and hospitals as needed.

Qualifications

• 5+ years hands‑on engineering in medical device development or 8+ years in another highly regulated industry.
• ABET‑accredited STEM degree (BS in ME, Biomed, or equivalent).
• Direct experience in new product and fixture design with hands‑on prototyping.
• Advanced CAD techniques including surfacing and FEA (Creo/SolidWorks).
• GD&T and tolerance stack‑up analysis and DFM for precision parts.
• Generate and review engineering specifications, drawings, test methods, and process characterization.
• Experience in highly regulated environments and strong analytical thinking.

Responsibilities

• Design new products, fixtures, equipment, and tools.
• Build and test prototypes through iterative cycles.
• Create 3D models and drawings with GD&T in CAD software.
• Develop documentation packages and qualification protocols.
• Execute IQ protocols and participate in V&V testing.
• Observe procedures and translate surgeon input into design needs.
• Collaborate with R&D and manufacturing to optimize manufacturability.

Skills

Engineering experience

CAD (Creo/SolidWorks)

GD&T and Tolerance stack‑up

Technical documentation

Regulated environments

Problem solving

Education

ABET‑accredited STEM degree

BS in Mechanical or Biomedical Engineering

Tools

Creo

SolidWorks

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 Design Engineer creates new medical devices and the fixtures, equipment, and tools Applied Medical uses to manufacture them at scale. Working across every phase of development, the Design Engineer studies surgical procedures, builds and tests prototypes, and delivers production-ready designs backed by complete technical documentation. This role fits an experienced design engineer with strong computer-aided design (CAD), prototyping, and design for manufacturing (DFM) skills who wants to see original designs move from concept into surgeons’ hands.

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

Key Responsibilities

• Design new products, fixtures, equipment, and tools to support medical device development and manufacturing scale-up.
• Build and test prototypes through iterative development cycles, refining designs based on surgeon feedback and test results.
• Create detailed 3D models and engineering drawings in CAD software such as Creo or SolidWorks, applying geometric dimensioning and tolerancing (GD&T) and tolerance stack-up analysis.
• Develop documentation packages, including drawings, test methods, engineering specifications, and qualification protocols.
• Execute installation qualification (IQ) protocols and participate in design verification and validation testing.
• Observe surgical procedures, document clinical challenges, and translate surgeon input into user needs.
• Refine product designs for manufacturability in partnership with research and development (R&D) and manufacturing teams.
• Collaborate with cross-functional engineering teams in brainstorming sessions and design reviews.

Success in This Role Looks Like

• Delivering original product and fixture designs ready for manufacturing with minimal rework.
• Producing clear, accurate technical documentation ready for design reviews and regulatory audits.
• Shortening development cycles through hands‑on prototyping and rapid iteration.
• Translating surgeon feedback into design changes with measurable usability improvements.
• Strengthening collaboration with R&D, manufacturing, and cross-functional partners through clear communication.

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, or eight or more years in another highly regulated industry such as aerospace, automotive safety systems, defense, pharmaceuticals, or biotechnology.
• 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 direct experience in new product design and fixture design, including original designs and hands‑on prototyping.
• Apply advanced CAD techniques, including surfacing and finite element analysis (FEA), in Creo, SolidWorks, or comparable software.
• Apply GD&T, tolerance stack‑up analysis, and DFM principles to precision machined parts.
• Generate and review technical documentation, including engineering specifications, drawings, test method validation, and process characterization.
• Work comfortably in highly regulated environments.
• Solve complex engineering problems through strong analytical, organizational, and critical thinking skills.

Preferred

The following skills and attributes are preferred:

• Apply working knowledge of materials and material properties, pneumatics, and electromechanical design.
• Qualify new materials, manufacturing processes, fixtures, and equipment.

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.

Our total reward package reflects our commitment to team member growth and well‑being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

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.