Senior R&D Engineer
Company: Jobot
Location: Irvine
Posted on: August 7, 2022
Job Description:
Calling all Senior R&D EngineerThis 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: $95,000 - $110,000
per yearA 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 insuranceJob DetailsDuties & 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 staffMinimum 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 EnglishPreferred 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.Interested in hearing
more? Easy Apply now by clicking the "Apply Now" button.
Keywords: Jobot, Irvine , Senior R&D Engineer, Engineering , Irvine, California
Didn't find what you're looking for? Search again!
Loading more jobs...