Sr. R&D Engineer; Catheters

Salary: USD
120000 - USD
130000 per year + 20% bonus

Must have Catheter Design Experience

100% onsite in Tustin, CA

No C2C or 3rd party candidates

• Technical Engineer responsible for new product development activities, taking a product through ideation, feasibility, regulatory approval, scale-up and commercialization.
• Work as a "hands‑on" Engineer to develop new designs and refine new products/processes to meet quality and production output targets.
• Identify and direct project activities and timeline to meet objectives within budget.
• Conduct feasibility studies to verify capability and functionality of new technologies.
• Design and implement test methods and equipment to support product development.
• Summarize, analyze, and draw conclusions from complex test results using statistics.
• Assemble complex protocols, report and communicate results to team and management.
• Develop product specifications and other DHF, DMR engineering documentation.
• Collaborate with Quality Engineering to deliver U/D/P FMEAs for new product platforms.
• Support design transfer activities executing on process validation such as IQ/OQ/PQs.
• Negotiate, and coordinate vendor activities to support aggressive development timelines.
• Demonstrate PDP system knowledge through high quality and high impact deliverables.
• Work cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success.
• Generate innovative solutions to address unmet market needs and draft idea disclosures.
• Train and provide work directions to lower level engineers and technicians.
• Works under only general supervision. Independently determines and develops approaches to solutions. Work is reviewed upon completion for adequacy in meeting objectives.

Bachelors of Science degree (BS) in mechanical engineering or related technical field.

6+ years of engineering experience, with medical device field preferred.

• Experienced with developing minimally invasive medical technologies, serving on a cross‑functional team, bringing the product through development cycle, to submission and launch.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other quality processes and procedures.
• Technical & Business Knowledge:
  Application of scientific principles, practices and procedures to solve challenging design problems. Strong experience working in cross functional team with OUS team members to deliver project to meet aggressive timelines.
• Experienced translating customer needs to product requirements.
• Demonstrated technical decision making with use of statistical tools.
• Strong in Solid Works, Mechanical Acumen and Hands on.
• Proven success with delivering concepts to manufacturing. Experienced with process validation, scale up, Takt time/Cycle time and DFM.
• Inventor of patented ideas and trade secrets.