Senior R&D Engineer
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 Senior R&D Engineer to support our Electrophysiology business. This role will work fully on-site in our Irvine, CA office. The Senior R&D Engineer will identify, evaluate and drive the product development activities of medical devices for the healthcare industry in collaboration with the engineering development and product management teams. Strong focus will also be on leading the transition of new products from engineering into production. Provides engineering and design services to manufacturing and production engineering groups. Develops concepts, designs and details for machines, tools, fixtures, and products.
Requirements
- BS or MS Degree in Chemical, Mechanical, Electrical Engineering or equivalent
- Minimum of 4 to 6 years of increasingly responsible product/process engineering experience
- Experience with DOE, FMEA, GMP, and QSR
- Proficient in Microsoft Office
- Strong statistical skills and knowledge of statistical software
- Ability to work within an ISO structured quality system
- Knowledge of engineered materials and fabrication methods
- Good planning, multi-tasking, and project management skills
- Demonstrated track record of completing projects on time and accomplishing goals
- Ability to function independently as well as part of a team
- Excellent written and oral communication skills
- Ability to manage multiple priorities in fast-paced environment
- Solidworks knowledge required
Nice To Haves
- Analytical Reasoning
- Coaching
- Computerized Equipment Skills
- Emerging Technologies
- Engineering
- Gemba Kaizen
- Mechanical Equipments
- Process Control
- Process Oriented
- Product Improvements
- Purchasing
- Research and Development
- SAP Product Lifecycle Management
- Situational Awareness
- Teamwork
- Technical Research
- Technologically Savvy
Responsibilities
- Develop and validate methods for reprocessing of assigned devices.
- Performs complex hands-on and simulated testing for design verification and test method developments.
- Reviews and edits all engineering documentation related to assigned projects, such as technical reports, work instructions and method and process validation.
- Leads basic engineering operations, and complex scientific evaluation on new products, technology concepts, and product development.
- Implements complex design concepts and ideas into working blueprints and drawings.
- Studies specifications, engineering blueprints, tool orders, and shop data and confers with engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost.
- Applies complex algebraic and geometric formulas and advanced tool engineering data to develop product configurations.
- Inspects and oversees testing of prototypes, tools, and fixtures after fabrication to ensure that they meet specifications.
- Write verification and validation documentation and conduct required testing as needed
- Perform reverse engineering to identify functional and performance requirements for reprocessed devices
- Oversee design and build of new components and assembly tooling
- Perform testing and inspection functions including forensics and root cause analysis
- Assist regulatory compliance efforts and verification and documentation related to engineering standards
- Responsible for communicating business-related issues or opportunities to next management level
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
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
- 10 days 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
