Senior Design Assurance Quality Engineer (Sustaining & NPD)

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer and has been recognized with the Catalyst Award in 2022, a prestigious recognition of diversity, equity, and inclusion excellence. Also, we have a Gender Equality Policy to support our commitment.

Hybrid Roles

Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview.

About The Role

This is an exciting mixed role of Sustaining and New Product Development (NPD) work, with an opportunity to work for a worldwide and diverse company who puts patients first. Through this position, the ideal candidate develops, establishes and maintains quality engineering methodologies, systems, and practices which meet Boston Scientific (BSC), customer, and regulatory requirements (Sustaining), and support medical device product development from concept through commercialization (NPD). In summary, providing quality engineering support sustaining existing product families and being part of new product development projects, as required.

Your Responsibilities Include

• Creative and resourceful problem-solving skills for moderate to complex mechanical and electrical devices. Including identifying, prioritizing, communicating, and resolving quality issues.
• Working within a team of Sustaining/NPD Engineers (embedded within R&D and Quality Assurance groups).
• Support the design, development, and testing of finished devices and accessories used in Boston Scientific Endoscopy product lines during their entire Development Life Cycle, from the Requirements gathering phase to the End-of-Life phase.
• Creation and review of Risk management/DQA documentation (e.g., Hazard Analysis, Task Analysis, Design Failure Modes and Effects Analysis (DFMEA), Fault Tree Analysis (FTA), Design Validation and Usability Engineering related documentation).
• Provide quality and compliance input for post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP’s, CAPA’s PIRs, Field Signals Evaluations and Field Actions.
• Participate in product, system, and sub-system level design reviews with focus on device design evaluation, product risk mitigation, and other required Risk Management activities.
• Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
• Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation and Labeling).
• Become a Subject Matter Expert (SME) for design controls and risk management requirements for the products supported.
• Support all aspects of DQA activities during internal and external audits, as needed.
  
  

Qualifications

What we're looking for:

• BS in Biomedical, or Mechanical Engineering, or equivalent technical discipline.
• Minimum of 5 years of Medical device engineering experience
• Working knowledge of the FDA, ISO, EUMDR and the medical device industry quality requirements associated with product development, design controls, product risk management, and usability engineering.
• Detailed understanding and working knowledge of US and International regulations including 21 CFR part 820, is required, as well as the Medical Device Directive / Medical Device Regulation, EN ISO 13485, EN ISO 14971 and IEC 60601 
• Strong communication (oral and written) and presentation skills.
• Preferred English Level: 80-89%.
• Travel approximately 10-15%, if required.
  
  

Expected Behaviors

• Proactive mindset and strong initiative
• Critical and analytical thinking
• Clear and open communication
• Strong attention to detail
• Creativity and problem-solving
• Collaboration and team orientation
  
  

Requisition ID: 608570

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!