Senior R&D Engineer (Onsite Irvine, CA)

The  Senior R&D Engineer supports project teams in the development of medical devices. This includes writing or verifying specifications, developing testing and product processes, and designing fixtures, to ensure the concepts and/or prototypes meet requirements.

What You Will Do

• Under minimal supervision; research, design, develop, modify, and verify components/modules for medical device product development and/or misc. activities. 

• Translate and/or define design inputs to engineering specifications and produce sub-system level designs. 

• Apply fundamental and some advanced concepts, practices and procedures to problem solving.

• Demonstrate advanced understanding of customer needs and design inputs.

• Demonstrate proficiency with product’s intended use and clinical procedures. 

• Learn how the financial models are constructed. ​ 

• Follow fundamental industry standards, design requirements, and test strategies which apply to regulatory requirements.

• Independently create or refine engineering documentation, such as the Design History file. 

• Follow R&D procedures like design controls and risk management, per the Quality Management System.

• Collaborate with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.

What You Need (Required Qualifications)

• Bachelor of Science Degree in Engineering; Mechanical Engineering or Biomedical plus 2+ years of relevant work experience. 

Preferred Qualifications (Strongly Desired)

• Master of Science Degree in Engineering, Mechanical Engineering or Biomedical preferred. 

• Working knowledge and understanding of mechanical engineering practices and design principles within a regulated environment. 

• Technical ability to create engineering drawings and models, applying GD&T and CAE tools.

• Demonstrated ability to apply knowledge of materials and manufacturing processes to product design. 

• Knowledge of Machine Shop and 3D printing practices. 

• Knowledge of Medical Device Manufacturing. 

$89,400 - $148,900 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.