25 Jan
Principal R&D Engineer
California, Irvine , 92602 Irvine USA

Vacancy expired!

Calling all Principal R&D EngineersThis Jobot Job is hosted by: Mordy OrnguzeAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $90,000 - $140,000 per year

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 DetailsWe 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
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.

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