Engineering Manager (Venous Valves)

Calling all Engineering Managers that have experience with Venous Valves

  • Irvine, CA
  • $135,000 - $140,000
  • Managed by Jobot Pro: Mordy Ornguze
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A bit about us:

Job Description

The Manager, Engineering is responsible for leading a team of engineers in the sustaining and development of novel bioprosthetic venous valve devices and related accessories such as but not limited to delivery systems. This position requires strong knowledge of 21 CFR 820.30, the design control process, study design, and statistical techniques. The Manager is responsible for developing engineers and ensuring that design control deliverables are met.

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:

  • Conceptualize, design and develop complex solutions for venous valves and related accessories such as but not limited to delivery systems
  • Oversee the development of prototypes, pre-clinical evaluations, and safety/efficacy testing in accordance with ISO 5840 and other applicable standards and regulations
  • Work collaboratively with Clinical, Manufacturing, Quality and Regulatory to ensure the design meets customer needs and is designed with consideration for Design-for-Manufacturing and Design-for-Quality
  • Assist with clinical studies, including evaluation of Human Factors
  • Develop risk documents (DFMEA, PFMEA, UFMEA, etc.)
  • Develop test methods and procedures to evaluate prototype device performance
  • Maintain compliance to internal and external requirements (21 CFR 820.30, 2017/745/EU)
  • Apply technical knowledge and judgment to complex engineering problems
  • Train clinicians on device use, as needed


Minimum Qualifications:

  • Bachelor’s degree in an Engineering discipline with 10+ years of medical device design engineering experience, with 3+ years in cardiac/vascular device development, OR
  • Master’s degree in an Engineering discipline with 8+ years of medical device design engineering experience with 3+ years in cardiac/vascular device development, OR
  • PhD in an Engineering discipline with 6+ years of medical device design engineering experience, with 3+ years in cardiac/vascular device development.
  • Experience in team leadership
  • Experience in tissue-based device (such as valve) design or transcatheter design
  • Strong knowledge of statistical techniques and DOE
  • Strong knowledge of ISO 5840 series
  • Proficient in SolidWorks and CAD drawings
  • Fluent in verbal and written English


Preferred Qualifications:

  • Bachelor’s in Biomedical Engineering or Mechanical Engineering, Master’s preferred
  • Knowledge of extrusions, braiding, molding, bonding, tissue, metal properties (SS and NiTi)
  • Knowledge of venous physiology and familiarity with clinical imaging modalities
  • Experienced taking device from concept to market


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 30% travel.
Easy Apply Now
Easy Apply Now
Job Details
Managed by Jobot Pro
Location
Irvine, CA
Job Type
Permanent
Compensation
$135,000 - $140,000