Staff R&D Engineer- NPD (Onsite Irvine, CA)
Summary
Designs and develops mechanical medical device components and systems from concept to launch, ensuring compliance with regulations and collaborating with cross-functional teams.
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