Engineer, Sr Quality

Additional Locations:  N/A

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

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role: 
This Senior Design Assurance Engineer role is a quality engineering role that primarily supports commercialized products for the Peripheral Intervention Division. The Design Assurance Engineer will work with a high-performing cross-functional sustaining team to ensure safety, quality, and compliance of commercialized products while continuously improving their value through end-of-life. He/she/they will be responsible for transferring products into sustaining including internally developed products, Sourced Finished Medical Devices, and acquired products. He/she/they will work in close partnership with Research and Development in ensuring products meet safety, efficacy, regulatory, and quality system and business requirements.

Your responsibilities will include:

• Working with cross-functional partners to achieve business goals and objectives while promoting teamwork in this cross-functional environment
• Partnering with R&D to ensure appropriate Design Controls are in place based on Customer Needs, Manufacturing input, and Risk Management.
• Working with and influencing cross functional team to identify and/or implement changes enhancing product performance, improving manufacturability, or reducing cost
• Applying sound, systematic problem-solving methodologies to investigate and resolve quality issues in a timely manner
• Supporting post market activities ensuring our products meet patient, customer, product performance, and quality system expectations through risk-based assessment of post-market signals (post market signals, field assessments, post market surveillance plans and reports, etc.)
• Actively participate in the Design Change process to ensure proposed changes to products are systemically and thoroughly analyzed and assessed
• Leading development and coordination of Design Verification, Validation, and Usability activities  
• Maintaining Design History File and Design Input / Output Documentation (product specifications, component specifications, prints, etc.)
• Generating, updating, and maintaining product risk management documentation (Hazard Analyses, Fault Tree Analysis, and FMEAs, etc.)

Required Qualifications: 

• Minimum of a Bachelor’s degree in an Engineering discipline or related field of study
• Minimum of 5 years of experience in design assurance, new product development, or related medical device experience
• Demonstrated use of Quality tools/methodologies.
• Working knowledge and application of verification, validation, and statistical techniques 

Preferred Qualifications: 

• Experience with project management
• ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
• Experience with IEC 60601
• Electrical Engineering and/or experience working with Medical Electrical Systems  
• Experienced problem solver, capable of facilitating the problem-solving process
• Experience with design changes, complaint reduction, and corrective action 
• Experience supporting Audits
• Experience interfacing with stakeholders to gather insight into continuous improvement, product performance, and strategic project prioritization and/or alignment 
• Self-motivated with a passion for solving problems and a bias for action
• Strong communication skills (verbal & written)
• Travel 10%

Requisition ID: 563924

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!