Job Title: Supervisor, Design Engineer – Medical Devices
Location: Union City CA 94587
FLSA Classification: Exempt

About the Role:
We are seeking a highly skilled Design Engineer Supervisor with a strong background in medical devices to lead the design and development of innovative surgical instruments. This role requires hands-on technical expertise, a passion for problem-solving, and the ability to supervise and mentor a small engineering team.

Why You’ll Love This Role:

Work on cutting-edge surgical metal tools and reusable medical devices.

Lead projects from concept to manufacturing in a regulated environment (ISO 13485 & FDA QMSR).

Directly impact product performance, patient safety, and manufacturing efficiency.

Key Responsibilities:

Lead design and development of medical devices, focusing on surgical metal tools and reusable instruments.

Supervise one other engineer, providing coaching, mentorship, and daily technical guidance.

Oversee the entire design control process, ensuring compliance with FDA QMSR and ISO 13485.

Conduct mechanical analyses (FEA, fatigue, DFMA, FMEA, DOE) to ensure robust and manufacturable designs.

Manage design documentation including DHF, DMR, and CAD specifications.

Collaborate across teams to solve complex engineering problems and implement continuous design improvements.

Approve engineering drawings, specifications, and validation protocols before release to manufacturing.

Required Qualifications:

Must come from the Medical Device field with experience designing surgical metal tools or reusable instruments.

Supervisory experience (managing at least one direct report).

BS in Mechanical, Biomedical, or Materials Engineering (or related field).

5+ years of experience developing medical devices.

Strong mechanical design skills and advanced proficiency in SolidWorks.

Hands-on experience with rapid prototyping, testing, and root cause problem solving.

Familiarity with design controls, risk analysis, verification, and validation.

Excellent communication and interpersonal skills; ability to collaborate with cross-functional teams.

Preferred Qualifications:

Experience with plastics and assemblies in medical devices.

Knowledge of design of experiments (DOE), statics, dynamics, kinematics, and FEA.

PDM experience in a regulated environment.

Work Environment:
Office and warehouse environment; moderate physical activity including walking, bending, lifting, and computer work.

Travel: Up to 10–20% for customer or supplier visits.

Why Join Us:
Be part of a dynamic team creating life-saving surgical tools, shaping the future of reusable medical devices, and mentoring the next generation of engineering talent.

Equal Opportunity Employer / Disabled / Protected Veterans

The Know Your Rights poster is available here:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf

The pay transparency policy is available here:
https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf

For temporary assignments lasting 13 weeks or longer, AppleOne is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf

We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.