Staff R&D Engineer- NPD (Onsite Irvine, CA)

What You Will Do

• 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/or 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.

What You Need (Required Qualifications)

• 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 (SolidWorks 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 (e.g., Word, Excel, PowerPoint)

Preferred Qualifications

• 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.

$102,700 - $171,100 USD Annual