Medical Device Design Engineer — CAD & Prototyping

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 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.