Systems Engineer - R&D

  • Irvine, CA
  • Posted 3 days ago | Updated 8 hours ago

Overview

On Site
USD 79,000.00 - 123,000.00 per year
Full Time

Skills

Writing
Product Requirements
Supervision
Testing
Root Cause Analysis
Problem Solving
Conflict Resolution
Regulatory Compliance
ISO 13485
Test Methods
Inspection
Prototyping
Documentation
Statistics
Collaboration
Research and Development
Mechanical Engineering
Biomedicine
Materials Science
Manufacturing
Product Design
Technical Writing
Communication
Medical Devices
SolidWorks
Legal

Job Details

Work Flexibility: Onsite

What You Will Do:

The R&D Engineer supports the design changes of commercialized devices and international submissions in the Inari Medical Division, including writing or verifying specifications, designing device improvements and fixtures, and conducting testing to adhere to product requirements and regulatory standards.

  • Design, develop, and verify mechanical components for medical devices under supervision, contributing to the overall engineering process.
  • Support prototyping and testing, including bench-level evaluations and verification against design requirements.
  • Conduct root cause analysis and problem-solving activities while ensuring traceability and compliance with requirements, including ISO 13485, EUMDR, and other international regulations.
  • Assist in developing test methods, fixtures, and inspection processes to evaluate new prototypes and materials as well as post-launch design changes at the material, component, and supplier level.
  • Contribute to Design History File documentation and understand design inputs, clinical use, and regulatory standards.
  • Perform statistical analysis and present findings that support product and process decisions.
  • Collaborate cross-functionally with internal teams (R&D, Quality, Regulatory, etc.) to support successful project outcomes.

What You Will Need:

Required Qualifications:
  • Bachelor's degree in Engineering (Mechanical, Biomedical, Materials/Materials Science) & 0 years of work experience
  • Foundational understanding of engineering principles, tools, and design practices
  • Familiarity with analysis tools and statistical methods
  • Basic knowledge of materials and manufacturing methods relevant to product design and development
  • Ability to read and interpret complex drawings and technical documentation
  • Strong communication skills to convey technical information internally and interface effectively with physicians

Preferred Qualifications:
  • Regulated industry experience (medical device)
  • Experience with Solidworks

  • $79k - $123k salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage: 10%

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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