Principal R&D Engineer
Calling all Principal R&D Engineers
  • Irvine, CA
  • $90,000 - $140,000
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A bit about us:

We are looking for a candidate with heart valve (or tissue-based device) design and verification/validation testing experience, great understanding of ISO 5840, high proficiency in SolidWorks and CAD, and preferably computational mechanics (FEA or CFD) background.

The Principal R&D Engineer is a member of the Engineering department. The role is involved in designing and developing prototypes of tissue based medical devices and related accessories including – but not limited to – delivery systems. The Principal Engineer is responsible for leading design control projects and risk analyses related to development and performance/safety evaluation.

Why join us?

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Disability insurance
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Relocation assistance
  • Vision insurance

Job Details

We are looking for a candidate with heart valve (or tissue-based device) design and verification/validation testing experience, great understanding of ISO 5840, high proficiency in SolidWorks and CAD, and preferably computational mechanics (FEA or CFD) background.

Duties & Responsibilities: **The ideal candidate will have experience with Class III tissue-based medical device design/testing experience***

  • Build, design, and test innovative ideas and iterations for our portfolio of products.
  • Develop design control plans related to tissue based devices and related accessories in accordance with 21 CFR 820.30
  • Identify performance testing required to ensure device safety/efficacy
  • Work cross-functionally with Clinical Affairs and clinicians to ensure Human Factors Engineering is incorporated into device design
  • Develop manufacturing Work Instructions
  • Ability to apply advanced mathematical and computational models to design related activities.
  • Identify vendors to develop custom components
  • Perform dimensional inspection on critical components
  • Work with Quality to ensure appropriate QC activities are identified to ensure device safety
  • Own Engineering CAPAs, NCRs, Observations, as appropriate and assigned by management
  • Create protocols and reports for studies performed in-house and externally (e.g., FEA, corrosion, AWT, etc.)
  • Perform risk assessment (e.g., FMEA, etc.)
  • Mentor junior staff

Minimum Qualifications

  • Experience in design and development of bioprosthetic valves and related accessories
  • B.S. in Biomedical Engineering or similar: 10+ years’ industry experience (7+ years’ with MS and 5+ years with PhD)
  • Strong understanding of the anatomy and functionality of the vascular and cardiac system
  • Strong understanding of ISO 5840, ISO 14971, ISO 22442-1 and design controls requirements per 21 CFR 820.30, 2017/745/EU
  • Experienced in risk analysis
  • Excellent understanding of mathematical and computational modeling
  • Advanced proficiency in SolidWorks and CAD drawings
  • Organized and team-oriented
  • Fluent in verbal and written English

Preferred Qualifications:

  • Strong understanding of FEA and computational modeling
  • Strong understanding of properties of processed and unprocessed tissues
Easy Apply Now
Easy Apply Now
Job Details
Managed by Jobot Pro
Location
Irvine, CA
Job Type
Permanent
Compensation
$90,000 - $140,000