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Job description
Staff Engineer – R&D
Irvine, CA
The Staff Engineer – R&D leads technical design activities for complex medical device development programs, from early concept through final product design. This role focuses on translating user and clinical requirements into system-level designs, developing and evaluating components and assemblies, and ensuring alignment with manufacturing and regulatory expectations.
What You Will Do
- Lead design and development of components, subassemblies, and full medical device systems from concept through validation
- Translate user needs and clinical requirements into system-level engineering designs and detailed specifications
- Evaluate and select prototyping and testing methods to verify product performance and reliability
- Design and review injection-molded components for functionality, manufacturability, and cost efficiency
- Develop engineering drawings, CAD models, and design documentation aligned with design control requirements
- Drive innovation by generating invention disclosures, patents, or trade secrets based on technical developments
- Collaborate with Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management to meet project milestones
- Mentor engineers and contribute to the development of engineering processes, tools, and best practices
What You Will Need
Required Qualifications
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related discipline
- Minimum 4 years of experience working in a regulated environment
- Experience in medical device development processes
- Experience designing injection-molded components
- Experience developing mechanical assemblies using DFM principles and CAD tools (SolidWorks or equivalent)
- Knowledge of materials, manufacturing processes, and product development technologies
Preferred Qualifications
- Master’s degree in Mechanical Engineering, Biomedical Engineering, or related discipline
- Experience in cardiovascular or vascular medical device development
- $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. Click here to learn more about: US Stryker employee benefits Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics 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.
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