R&D Engineer II - Electrophysiology

at  Boston Scientific Corporation

REQUIRED QUALIFICATIONS:

• 3+ years of related experience in medical devices with a focus on Research and Development
• Mechanical/Biomedical Engineering degree with a focus on biomedical
• Knowledge of the design requirements as per 21 CFR 820 and ISO 13485
• Experience with drafting and maintaining DHF and DMR documentations
• Experience with leading rapid design iteration and making design recommendations
• Ability to independently develops and adapts work plans based on vague or changing project goals
• Strong hypothesis-driven experimental design and statistical analysis skills
• Candidates should be self-starters and have a hands-on approach
• Ability to work independently and within a diverse group of Engineers and Production staff
• Strong communication skills (verbal/written)

PREFERRED QUALIFICATIONS:

• Experience with catheter devices or platform development.
• Possess a strong interest in biomedical technology.
  Requisition ID: 591480
  As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
  So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
  Job Segment: R&D Engineer, R&D, Biomedical Engineering, Medical Device, Drafting, Engineering, Research, Healthcar

ABOUT THE ROLE

The R&D Engineer II to assist with the sustainable activities of medical devices. This role’s responsibilities support continuous improvement, product analysis on complaints, testing and training. The engineer will also participate on new product development teams. Our engineers are involved in all aspects of the medical device development including concept generation, design, prototyping, and manufacturing transfer. These individuals also have an opportunity to work with the appropriate government bodies to obtain regulatory approval.

YOUR RESPONSIBILITIES WILL INCLUDE:

• Investigate product complaints at clinical/customer sites, perform root cause analysis of failures, and propose remediation in a timely fashion
• Analyze Complaint data and generate prioritized actions to address shortcomings associated with the company’s products
• Review existing product design, identify weaknesses, propose, implement, and monitor effectiveness of improvements.
• Analyze mechanical designs
• Create strategy for the verification of the corrective designs, and participate in verification activities.
• Produce and revise DHF and DMR documentation as needed
• Contribute to risk management content such as FMEA, PFMEA and hazard analysis
• Perform all duties in compliance with the quality management system; actively contribute to the continuous improvement projects.
• Support cross functional team in Post Market Surveillance activities.
• Support regulatory filings to various government bodies
• Respond to field Requests