Design Assurance Engineer III

at  Boston Scientific Corporation

REQUIRED QUALIFICATIONS:

• Bachelor’s Degree in Engineering (Electrical or Biomedical preferred)
• 3+ years related working experience from Medical Device Industry
• Knowledge of ISO 13485, ISO 14971, IEC 62366-1, IEC 62304
• Demonstrated interpersonal skills with ability to work within a team environment
• Strong written/verbal communication skills
• Must be able to work independently under limited supervision

PREFERRED QUALIFICATIONS:

• Six Sigma problem solving methodologies
• Training experience to FDA regulations or ISO standards
  Requisition ID: 577938
  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: Biomedical Engineering, Six Sigma, PLM, Medical Device Engineer, Statistics, Engineering, Management, Dat

ABOUT THE ROLE

Our team is growing, and we are currently looking for a Design Assurance Engineer III to join our Design Assurance team. This position works closely with Medical Electrical Equipment/Capital Equipment new product introduction and product life cycle teams to ensure adequate design controls are met and subsequent production and process controls are adequate.

YOUR RESPONSIBILITIES WILL INCLUDE:

• Responsible for design control and risk management of next-generation capital equipment devices.
• Uses clinical knowledge/Data to influence how devices they are working on are tested and designed.
• Responsible for the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
• Builds quality into all aspects of work by maintaining compliance to all quality requirements.
• Plans, organizes and prioritizes own daily work routine to meet established schedule.
• Utilize standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
• Apply technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Other duties as required.