Staff R&D Engineer - Sustaining & Model Development

  • Irvine, CA
  • Posted 3 days ago | Updated 7 hours ago

Overview

On Site
USD 100,000.00 - 165,000.00 per year
Full Time

Skills

Innovation
Writing
Research Design
Medical Devices
Marketing
Project Management
Prototyping
Testing
Regulatory Compliance
ISO 13485
Documentation
Mentorship
Research and Development
Risk Management
Quality Management
Mechanical Engineering
Biomedical Engineering
3D CAD
Modeling
SolidWorks
Design Controls
GD&T
Manufacturing
Product Design
Legal

Job Details

Work Flexibility: Onsite

At Stryker's Inari Medical, we are transforming the lives of patients suffering from venous and other vascular diseases through purpose-driven innovation. As a fast-growing medical device company, we develop breakthrough technologies that treat life-threatening conditions with speed, safety, and precision. Join us in shaping the future of vascular health.

The Staff R&D Engineer supports and leads project teams in the development of medical device products - this includes writing or verifying specifications, developing testing and product processes, and designing fixtures to ensure the concepts and/or prototypes meet requirements.

Learn more about the Division Here: Inari Medical

What You Will Do:
  • Independently research, design, develop, modify, and verify mechanical components for medical devices while working cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.
  • Conduct or design advanced prototyping and testing.
  • Create benchtop models to simulate clinically relevant and challenging use conditions.
  • Support Voice of Customer sessions internally and with clinicians.
  • Analyze and correct complex product design issues using independent judgment. Ensure traceability and compliance with requirements, including ISO 13485, EUMDR, and other international regulations.
  • Support and execute segments of complex multifunctional teams to advance post-launch design changes at the material, component, and supplier level.
  • Lead creation and refinement of engineering documentation, such as the Design History file.
  • Follow and mentor others on R&D procedures like design controls and risk management, per the Quality Management System.

What You Will Need:

Required Qualifications:
  • Bachelor's Degree in Mechanical Engineering, Biomedical Engineering or related discipline
  • 4+ years of work experience in a regulated industry
  • Proficient in 3D CAD modeling (Solidworks Preferred)
  • Experience with design control

Preferred Qualifications:
  • Experience in creating engineering drawings, models, applying GD&T, and CAE tools to optimize the design
  • Adept at applying knowledge of materials and manufacturing processes to product design
  • Pre-clinical and/or clinical experience
  • 510(k) and/or PMA experience

  • $100k - $165k salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
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