R&D Engineer II - Electrophysiology
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 R&D Engineer 2 to support our Electrophysiology business. This role will work onsite in our Irvine, CA office. A Level 2 R&D Mechanical Engineer contributes to the design, development, verification, and transfer-to-manufacturing of electrophysiology (EP) and ultrasound catheter products. The role works on cross-functional project teams to deliver safe, reliable, and manufacturable catheter shafts, steerable mechanisms, and miniaturized ultrasound transducer assemblies used in EP or Structural Heart procedures.
Requirements
- BS in Mechanical Engineering, Biomedical engineering, or related engineering discipline.
- With a BS and prior medical device experience: 2–4 years of industry product development experience.
- With a BS and experience in another regulated industry (e.g., pharmaceutical, aerospace, automotive, defense): 4+ years of industry experience.
- With an MS: may substitute for 1–2 years of experience.
- Familiarity with design controls, verification/validation processes, and risk management in regulated environments.
- Hands-on bench-testing experience
- Proficiency in 3D CAD (SolidWorks) and creation of detailed drawings with GD&T.
- Fundamental understanding of mechanical mechanisms
- Strong problem-solving, data analysis, and communication skills; proven ability to work in cross-functional teams.
Nice To Haves
- Prior hands-on experience prototyping with intracardiac/vascular EP catheters, ultrasound imaging catheters, or minimally invasive delivery systems.
- Experience designing articulating shafts for minimally invasive catheters.
- Experience supporting or leading the design of a medical device component or assembly
- Experience identifying critical design requirements, then characterizing and documenting the requirement.
- Experience using Minitab or similar statistical software for analysis
- Familiarity with Six Sigma Methodology for problem solving.
- Experience working on early stage conceptual design projects
- Knowledge of Product Development Process
- Experience developing fixtures and test methods
- Experience with PLM systems (Windchill)
- Experience with FEA software such as ANSYS or COMSOL.
- Exposure to receiving and translating clinical requirements to prototypes
Responsibilities
- Design and develop mechanical components and assemblies for medical devices using SolidWorks (3D modeling and detailed drawings).
- Actively contributes to the definition and development of innovative patents.
- Support design control activities: requirements decomposition, design verification and validation planning/execution, and Design History File documentation.
- Plan and execute engineering characterization: develop test fixtures, instrument systems, collect/analyze mechanical/electrical/acoustic data, and prepare technical characterization reports.
- Support verification testing and system integration: develop/execute verification plans and protocols, assist with test setup/troubleshooting, validate mechatronic and software–hardware interactions, and document results.
- Perform tolerance analysis, tolerance stack-ups, and tolerance optimization for manufacturability and assembly.
- Conduct engineering analyses: basic FEA, control/dynamic assessments, material selection, and fluid/mechanical performance evaluations.
- Develop prototypes, lead bench testing, iterate designs based on test results and usability feedback, and support automated test fixture development.
- Participate in risk management activities: identify hazards, support FMEAs, and implement mitigations addressing mechanical, electrical related risks.
- Support engineering change requests and provide technical input for supplier qualification and production ramp.
- Collaborate with manufacturing, supply chain, quality, regulatory, and clinical teams to support transfer-to-production and process validation.
- Support supplier technical evaluations and provide technical direction during supplier qualification and production ramp.
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
- Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
