Design Engineer

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

Benefits offered by this job

Competitive pay

Comprehensive benefits

Mentorship opportunities

Wellness activities on campus

Education reimbursement

401(k) with discretionary employerm at

Generous vacation accrual

Job summary

Applied Medical is seeking a Design Engineer to create medical devices and the fixtures and tools used to manufacture them at scale. You will study procedures, build prototypes, run tests, and deliver production-ready designs with full technical documentation.

Travel to visit surgeons and hospitals is required. You are an experienced designer with CAD skills in Creo or SolidWorks, strong prototyping and DFM know-how, and a proven track record turning concepts into manufacturable products for the

Qualifications

• Five+ years hands-on engineering in medical device product development.
• BS in mechanical/biomedical engineering or ABET-accredited STEM degree.
• Direct experience in new product design and fixture design with hands-on prototyping.
• Advanced CAD techniques including surfacing and FEA in Creo/SolidWorks.
• GD&T and tolerance stack-up analysis in DFM for precision parts.

Responsibilities

• Design new products, fixtures, equipment, and tools for medical device development and scale-up.
• Build and test prototypes through iterative cycles, refining designs from surgeon feedback and test results.
• Create 3D models and drawings in CAD with GD&T and tolerance analysis.
• Develop documentation packages, including drawings and qualification protocols.
• Execute IQ protocols and participate in design verification and validation testing.
• Observe surgical procedures and translate input into user needs.
• Refine product designs for manufacturability with R&D and manufacturing teams.
• Collaborate with cross-functional teams in design reviews.

Skills

CAD design

Creo

SolidWorks

FEA

GD&T

DFM

Prototyping

Medical device experience

Regulated environment

Technical documentation

Education

BS in Mechanical Engineering

ABET-accredited STEM degree

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.

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.