Senior Design Assurance Engineer - Electrophysiology

at  Boston Scientific Corporation

REQUIRED QUALIFICATIONS:

• Bachelor’s Degree in Engineering (Mechanical or Biomedical preferred)
• 5+ years of relevant work experience
• Knowledge of ISO 13485, ISO 14971, IEC 62366-1
• Experience with design controls, design inputs and outputs, and risk mitigation activities
• Excellent analytical and communication skills (written and oral)
• Excellent organization and time management skills
• Interest in biomedical or health-related industry

PREFERRED QUALIFICATIONS:

• 2+ years of experience directly in a Design Assurance role
  Requisition ID: 594787
  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, Electrophysiology, PLM, Compliance, Design Engineer, Engineering, Healthcare, Management, Lega

ABOUT THE ROLE

Our team is growing, and we are currently looking for a Senior Design Assurance Engineer to join our Design Assurance Quality team. This position works closely with new product development 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 novel electrophysiology devices.
• Uses clinical knowledge to influence how devices they are working on are tested and designed
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects
• Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
• Demonstrates good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards
• Adds to and promotes the culture of quality-centric patient care and customer satisfaction within the New Product Development team
• Promotes and influences compliance to BSC’s quality, business and health & safety systems and market/legal regulations
• Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines). Comply with the Health & Safety policies of the company and inform management of unsafe working conditions.
• Other duties as required.