Senior R&D Engineer

Calling all Senior R&D Engineer

  • Irvine, CA
  • $95,000 - $110,000
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A bit about us:

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

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

Duties & Responsibilities

  • Build, design, and test innovative ideas and iterations for our portfolio of products (e.g., venous valves, delivery systems, etc.)
  • Develop design control plans related to valves 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 related to valve and related accessories design
  • Apply advanced mathematical and computational concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations and computational models to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis
  • 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., DFMEA, PFMEA, UFMEA, etc.)
  • Mentor junior staff

Minimum Qualifications

  • Experience in design and development of bioprosthetic valves and related accessories
  • B.S. in Biomedical Engineering or similar: 5+ years’ industry experience
  • M.S. in Biomedical Engineering or similar: 3+ years’ industry experience
  • Ph.D in Biomedical Engineering or similar
  • 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
  • Proficient in SolidWorks and CAD drawings
  • Organized and team-oriented
  • Fluent in verbal and written English

Preferred Qualifications:

  • Strong understanding of properties of metals/electropolishing
  • Strong understanding of properties of processed and unprocessed tissues

Physical Job Requirements:

  • This position includes working in an office and operating room environment and may involve standing or sitting for several hours at a time. This job requires up to 10% travel.
Easy Apply Now
Easy Apply Now
Job Details
Managed by Jobot Pro
Location
Irvine, CA
Job Type
Permanent
Compensation
$95,000 - $110,000