Senior Design Quality Assurance Engineer

Additional Location(s):  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 this role:
The Senior Design Quality Assurance Engineer is an experienced professional with wide-ranging experience and expertise in quality engineering and regulatory requirements applicable to the medical device industry. The Senior Design Quality Assurance Engineer will develop, establish and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. 
This is a hybrid position based out of Marlborough, MA with the expectation to be in the office a minimum of three days per week.  

Your responsibilities include: 

• Provide quality and compliance input and coaching for product development and/or post market product sustaining activities, such as EUMDR Notified Body questions, Product Inquiry Reports (PIR), Additional Information (AI) requests, CE marking, Design Changes, NCEP’s and CAPA’s.
• Promotes Cross-Functional collaboration and has ability to influence project strategy.  Capable of working independently on highly specialized projects with long range objectives.  
• Leads the execution of Quality Deliverables such as project Design & Development Plans, Design Changes, and Design & Usability Validation Plans. Leads the execution of Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques, and evaluation criteria for obtaining results. 
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Supports internal and external regulatory audits. External audit facing.
• Provides technical leadership to business units. Advises management on potential improvements or enhancement to quality systems and processes. 
• Support development, implementation and training of corporate quality initiatives.  

What we’re looking for in you:
Required Qualifications

• Bachelor of Science in Biomedical, Mechanical Engineering or related degree.
• Minimum of 5 years of medical device engineering experience.
• In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
• Strong communication and presentation skills.
• Solid technical writing skills.
• Travel <10%, if required

Preferred Qualifications

• 8+ years of medical device engineering experience 
• Master's degree 

Requisition ID: 592392

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.  

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 meani