Position – Design Engineer Supervisor
- Pay Rate:$90K- $100K USD Base
- Location: Union City, CA
Raise is currently hiring a permanent, full-time team member on behalf of our client. They’re expanding their team to meet growing needs, making this a unique opportunity to work with an industry leader.
Full job description
SCOPE: Reporting to the Manager of Product Development and Quality Assurance, the Design Engineer Supervisor leads the conceptualization, testing, and implementation of innovative medical device designs and manufacturing processes. This role acts as a bridge between technical execution and strategic oversight, ensuring that all product development lifecycles adhere to strict cost-efficiency, usability, and environmental sustainability standards. The Supervisor provides technical leadership to the engineering team, ensuring that every project aligns with the company’s Quality Management System (QMS) while strictly complying with ISO 13485:2016 and the updated FDA 21 CFR Part 820 (QMSR).
ESSENTIAL JOB FUNCTIONS:
• R&D Leadership: Spearhead the Design and Development division by defining clear technical objectives and executing project milestones through the entire Design Control process.
• Engineering Excellence: Direct complex engineering analyses, including FEA, Fatigue Analysis, DFMA, FMEA, and DOE, to ensure robust product performance and manufacturability.
• Regulatory Compliance: Ensure all development documentation satisfies the requirements of the FDA QMSR (effective Feb 2026) and ISO 13485.
• Quality & Risk Management: Lead the technical review of non-conformances (NCR), manage Material Review Board (MRB) activities, and perform root cause analysis for customer complaints to drive design improvements.
• Documentation Management: Oversee the accuracy and completeness of the Design History File (DHF), Device Master Record (DMR), and all international drafting standards (GD&T).
• Continuous Improvement: Utilize field reliability data and user feedback to iterate existing designs, improving sterilization compatibility, biocompatibility, and automated manufacturing efficiency. Supervisory Responsibilities
• Team Development: Provide daily directions to the design engineering team, coaching and mentoring staff to enhance technical proficiency in CAD and medical device regulations.
• Project Oversight: Assign work packages, monitor progress against project timelines, and serve as the primary technical point of escalation for engineering challenges.
• Performance Management: Conduct regular performance evaluations and team meetings to communicate organizational priorities and resolve cross-functional bottlenecks.
. Strategic Growth: Assist in defining staffing requirements, lead the interview process for new engineering talent, and oversee the onboarding of new hires to ensure cultural and technical alignment.
• Deliverable Approval: Finalize and approve engineering drawings, specifications, and project validation protocols before release to manufacturing.
PHYSICAL REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Duties are performed while sitting at a desk, walking, bending, squatting, lifting, carrying, pulling and pushing within the office area and warehouse will be required as needed on a daily basis. Required duties include operating a computer frequently (about 85% of the time), reading, writing and communicating email correspondence (about 60%), and using a telephone (about 10% of the time).
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Job duties are performed in an office and wharehouse environment utilizing standard office equipment such as a computer, and telephone. The noise level in the work environment is usually low to moderate.
MINIMUM QUALIFICATIONS – The qualifications below are the knowledge, skills, and abilities required to do this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
KNOWLEDGE, SKILLS, AND ABILITIES:
•
BS Mechanical Engineering, Biomedical Engineering, or Materials Engineering (or related science/engineering area)
•
5+ years of experience developing medical products. Experience with metals or reusable surgical instruments is a plus
•
Must be highly capable using SolidWorks. Skilled in mechanical design and use of CAD to create detailed 3D models and engineering drawings. Must be highly capable of using SolidWorks
•
Experience creating rapid prototypes and mock-ups and evaluating designs via testing and rigorous analysis
•
A passion for solving tough technical problems – Strong mechanical intuition and persistence to drill down to pinpoint root cause of problems, solving problems using fundamental principles
•
Demonstrated ability to think at a systems level, interface between multiple design groups, and negotiate conflicting requirements
Proficiency using CAD to design parts and assemblies and to create specification drawings in a PDM environment; Solid works strongly preferred
•
Hands-on engineering with the ability to work well in a team environment
•
Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer
•
Familia and Comfortable with concepts of design input, design output, traceability, and risk analysis
•
Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials and stress analysis (FEA); familiarity with statistics and design of experiments
•
Experience designing plastic components and assemblies
•
Excellent interpersonal and communication skills, both written and verbal, and ability to effectively communicate technical issues
•
Familiar with phases of the product development lifecycle, including conceptualization, design, verification, validation, and transfer to manufacturing
•
Proficiency in technical writing
TRAVELS
•
This position may require 10 to 20% of time to meet with customers.
Looking for meaningful work? We can help
Raise is an established hiring firm with over 65 years of experience. We believe strongly in making the world a better place through work, which is why we’re a certified B Corporation and donate 10% of our profits to charity.
We strive to build teams that reflect the diversity of the communities we work in. We encourage all qualified applicants to apply, including people from traditionally underrepresented groups such as women, visible minorities, Indigenous peoples, people identifying as LGBTQ2SI, veterans, and people with visible/nonvisible disabilities.
We have a dedicated webpage for accommodations where you can learn more about what we offer, and request accommodation: https://raise.jobs/accommodations/
In order to submit candidates for roles, our clients will sometimes require personal information to confirm the identity of applicants and their legal status to work. Raise will never ask you for personal or banking information unless you have been selected for a job. If you are ever unsure about the legitimacy of this or another job posting by Raise (or have any other questions), please contact us at +1 800-567-9675 or hello@raiserecruiting.com
#LI-AJ1
#RWI