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

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.