Staff Mechanical Engineer, R&D
About The Position
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. We are searching for the best talent for a Staff Mechanical Engineer, R&D, to support our Electrophysiology business. This role will work onsite in our Irvine, CA office. The Staff Mechanical Engineer, R&D will be supporting project teams in the development of electrophysiology catheters and systems at Biosense Webster and provides advice and mentorship to less experienced personnel. Project support includes overall design, requirement development, design for manufacturing, design transfer, test method development, and product verification and validation testing.
Requirements
- A Bachelor’s Degree in Mechanical (preferred) or Biomedical Engineering with a minimum of 8 years of experience, or a Master’s degree with minimum of 6 years of experience, or PhD and 4 years of industrial experience is required.
- Experience with CAD software such as SolidWorks is required.
- Strong understanding of engineering materials, component selection, and design for reliability and manufacturability is required.
- Strong understanding of data analysis and statistics including design of experiments, Gage R&R, capability, etc. is a strong plus.
- Must possess strong communication skills, written and verbal
- Ability to solve complex problems
- Ability to travel up to 25% domestic and international is required
Nice To Haves
- 3 years’ experience in early-stage (pre-design freeze) catheter and/or cardiovascular device development is preferred.
- Knowledge and experience in product development processes is preferred.
- Ability to speak Spanish is preferred
Responsibilities
- Lead design transfer of next-generation EP catheter platforms while strictly ensuring compliance with FDA and ISO medical device standards.
- Lead the design of new or existing components and/or devices while ensuring that all design requirements are met.
- Develop customer requirements and product specifications with validated test methods
- Support or lead quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Study specifications, engineering blueprints, tool orders, and shop data and confer with engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost.
- Interface between external vendors and core team.
- Expected to present project work across management levels and to customers and author scientific publications and patents in support of key technologies.
- Expected to write reports, work instructions, test methods and procedures.
- Travel to customer sites, domestic and international, to gather VOC, perform testing and/or perform troubleshooting activities.
- Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound processes and designs.
- Provide technical mentoring to less experienced engineers and technicians
- Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
