Job Description

Our client is seeking a Design Engineer Supervisor to provide technical and people leadership for the design, development, testing, and implementation of medical device products and manufacturing processes. This role partners closely with Product Development and Quality leadership to ensure product development activities comply with applicable regulatory requirements, quality system standards, and business objectives.

Responsibilities

• Lead and oversee design and development activities across the full product lifecycle, from concept through transfer to manufacturing.
• Provide technical leadership and mentorship to the design engineering team, including daily direction, coaching, and performance feedback.
• Drive execution of the Design Control process in compliance with ISO 13485:2016 and FDA 21 CFR Part 820 (QMSR, effective February 2026).
• Direct and review complex engineering analyses, including FEA, fatigue analysis, DFMA, FMEA, and Design of Experiments (DOE).
• Ensure product designs meet performance, usability, manufacturability, cost, and sustainability requirements.
• Lead technical reviews of nonconformances (NCRs), manage Material Review Board (MRB) activities, and perform root cause analysis for complaints and field issues.
• Oversee development and maintenance of design documentation, including DHF, DMR, engineering drawings, and specifications in accordance with GD&T standards.
• Serve as the primary technical escalation point for complex engineering challenges and cross-functional issues.
• Assign and manage engineering work packages, monitor project timelines, and support on-time project execution.
• Review, approve, and release engineering drawings, specifications, and validation protocols prior to manufacturing transfer.
• Utilize field data and user feedback to drive continuous improvement in design robustness, sterilization compatibility, biocompatibility, and automated manufacturing efficiency.
• Support staffing needs, interview candidates, and assist with onboarding of new engineering team members.
• Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and other stakeholders to support business and project objectives.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or a related engineering discipline.
• 3-5 years of experience developing medical device products.
• Experience with metals and/or reusable surgical instruments preferred.
• Advanced proficiency with SolidWorks for 3D modeling, assemblies, and detailed engineering drawings in a PDM environment.
• Strong mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials, and stress analysis (FEA).
• Experience designing plastic components and assemblies.
• Hands-on experience with rapid prototyping, testing, verification, and validation activities.
• Solid understanding of the medical device product development lifecycle, including design inputs/outputs, traceability, risk management, verification, validation, and transfer to manufacturing.
• Familiarity with ISO 13485 and FDA Quality System Regulation (21 CFR Part 820 / QMSR).
• Strong problem-solving skills with the ability to identify root causes using fundamental engineering principles.
• Systems-level thinker with the ability to interface across multiple design groups and balance competing requirements.
• Excellent written and verbal communication skills, including technical writing.
• Ability to work effectively in a collaborative, cross-functional team environment.
• Willingness to travel up to 10–20% as required.

Location

• Union City, CA

Employee Type

• Direct Placement

Compensation

• $100,000
• Comprehensive benefits package

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com

Equal Opportunity Employer Minorities/Women/Veterans/Disabled