Job Title: Design Engineer Supervisor
• Location: Union City, CA.
• Great Pay to $100K
Immediate need for a Design Engineer Supervisor.
Build the Future of Medical Devices
Are you a hands-on engineering leader who thrives at the intersection of innovation, quality, and real-world impact? Do you love mentoring engineers, solving complex technical challenges, and bringing regulated medical products from concept to reality?
If so, we’d love to meet you.
About the Role:
As a Design Engineer Supervisor, you’ll lead a talented team of engineers developing innovative medical devices that make a real difference in patients’ lives. Reporting to the Manager of Product Development and Quality Assurance, you’ll guide products through the full design control lifecycle—while ensuring compliance with ISO 13485 and FDA QMSR requirements.
This is a highly visible role where technical excellence, leadership, and strategic thinking all come together.
What You’ll Be Doing:
Lead and mentor a high-performing design engineering team through complex product development programs
Drive design control activities from concept through validation and transfer to manufacturing
Perform and oversee advanced engineering analyses (FEA, DFMA, FMEA, DOE, fatigue analysis)
Ensure compliance with FDA 21 CFR Part 820 (QMSR) and ISO 13485:2016
Own critical documentation including DHFs, DMRs, and engineering drawings (GD&T)
Lead root cause analysis for quality issues, NCRs, MRB activities, and customer feedback
Collaborate cross-functionally with Quality, Manufacturing, Regulatory, and Operations
Approve final designs, specifications, and validation protocols before production release
Leadership & Growth:
Coach and develop engineers in CAD best practices, medical device regulations, and problem-solving
Assign project work, manage timelines, and remove roadblocks
Participate in hiring, onboarding, and building the next generation of engineering talent
Act as the technical escalation point for complex design challenges
What You Bring:
Bachelor’s degree in Mechanical, Biomedical, Materials Engineering, or related field
5+ years of medical device product development experience (metals or reusable surgical instruments a plus)
Advanced proficiency in SolidWorks and 3D mechanical design
Strong background in mechanical analysis (FEA, stress, fatigue, statics/dynamics)
Deep understanding of design controls, risk management, and regulated product development
Hands-on mindset with excellent communication and leadership skills
Passion for solving hard problems and continuously improving designs
Travel:
Occasional travel (10–20%) to support customers and project needs
Why You’ll Love It:
Work on meaningful products that improve patient outcomes
Lead with autonomy and make a visible impact on product direction
Collaborate with smart, driven professionals in a quality-focused environment
Be part of a company that values innovation, compliance, and continuous improvement
Ready to lead, innovate, and make an impact?
Apply today as a Design Engineer Supervisor and help design the next generation of medical devices.
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.
(none specified)