We are seeking an experienced Design Engineer Supervisor to lead the design, development, and implementation of innovative medical device products and manufacturing processes for our client. Reporting to the Manager of Product Development & Quality Assurance, this role blends hands-on engineering expertise with strategic leadership, regulatory compliance, and team development.

This position plays a critical role in ensuring all product lifecycles meet cost, usability, sustainability, and regulatory standards, including ISO 13485:2016 and the FDA QMSR (21 CFR Part 820, effective Feb 2026).

Key Responsibilities
R&D & Engineering Leadership
Lead the Design & Development function through the full Design Control lifecycle
Direct complex engineering analyses including FEA, Fatigue Analysis, DFMA, FMEA, and DOE
Drive robust, manufacturable, and compliant product designs
Regulatory & Quality Compliance
Ensure development documentation meets FDA QMSR and ISO 13485 requirements
Oversee DHF, DMR, GD&T, and technical documentation accuracy
Lead NCR reviews, MRB activities, and root cause analysis for complaints
Continuous Improvement
Use field reliability data and user feedback to improve product performance
Enhance sterilization compatibility, biocompatibility, and automated manufacturing efficiency

Supervisory Responsibilities
Provide daily leadership, coaching, and mentorship to design engineers
Assign work packages, monitor timelines, and act as the technical escalation point
Conduct performance reviews, team meetings, and cross-functional coordination
Support strategic growth by helping define staffing needs, interviewing, and onboarding new engineers
Approve engineering drawings, specifications, and validation protocols prior to manufacturing release

Qualifications & Experience
BS in Mechanical, Biomedical, Materials Engineering, or related discipline
5+ years of medical device product development experience (metals or reusable surgical instruments a plus)
Advanced proficiency in SolidWorks (required)
Strong mechanical design and analysis skills (FEA, statics, dynamics, strength of materials)
Experience with rapid prototyping, testing, verification, and validation
Deep understanding of design inputs/outputs, traceability, and risk management
Experience designing plastic components and assemblies
Excellent technical writing, communication, and leadership skills
Comfortable working hands-on across the full product development lifecycle

Work Environment & Travel
Office and warehouse environment
Frequent computer use and technical documentation
10–20% travel to meet with customers as needed

If you’re passionate about medical device innovation, engineering leadership, and building compliant, high-quality products that make a real impact, we’d love to connect.

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.