R&D Engineer- NPD; Onsite Irvine, CA

Responsibilities

• Lead the design, development, and optimization of mechanical medical device components, assemblies, and/or subsystems from concept through commercialization.
• Translate user, customer, and clinical needs into design inputs, engineering specifications, and system-level product requirements.
• Develop and execute design verification and validation strategies, including prototyping, testing, and analysis to ensure product performance and reliability.
• Apply sound engineering judgment to identify, troubleshoot, and resolve complex product design challenges.
• Create and maintain engineering documentation including CAD models, drawings, GD&T specifications, test protocols, test reports, and Design History File (DHF) deliverables.
• Collaborate cross-functionally with Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management teams to drive successful product development and launch activities.
• Support Voice of Customer (VOC) initiatives and utilize clinical and market insights to develop innovative product solutions.
• Ensure compliance with medical device regulations, industry standards, design controls, risk management processes, and quality system requirements.

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 4+ years of relevant engineering experience.
• Experience developing mechanical and/or electro‑mechanical products in a regulated industry, preferably medical devices.
• Strong expertise in product design, Design for Manufacturability (DFM), materials selection, manufacturing processes, and mechanical problem‑solving.
• Proficiency creating engineering drawings (GD&T experience preferred) and 3D CAD models (Solid Works preferred).
• Experience with prototyping, verification and validation testing, data analysis, and root‑cause investigation.
• Working knowledge of Design Controls, Risk Management, and Quality Management Systems within a regulated product development environment.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint).

• Medical device manufacturing experience.
• Experience with machine shop operations, injection molding, and additive manufacturing (3D printing).
• Experience supporting FDA submissions, including 510(k) and/or PMA programs.
• Familiarity with applicable medical device regulations and industry standards.
• Experience with MS Project and Minitab.

• Medical and prescription drug insurance
• Dental insurance
• Vision insurance
• Critical illness insurance
• Accident insurance
• Hospital indemnity insurance
• Personalized healthcare support
• Wellbeing program
• Tobacco cessation program
• Health Savings Account (HSA)
• Flexible Spending Accounts (FSAs)
• 401(k) plan
• Employee Stock Purchase Plan (ESPP)
• Basic life and AD&D insurance
• Short‑term disability insurance

$102,700 - $171,100 USD Annual