Principal Quality Systems Engineer -Global Design Controls  (Remote optional)

Additional Location(s): US-MN-Maple Grove; US-CA-Valencia; US-GA-Alpharetta; US-IN-Spencer; US-MA-Marlborough; US-MN-Arden Hills

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:

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.   Serves as a Global Design Controls Quality representative to improve awareness, visibility, and communication on global initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.  Partner with design teams across all divisions to drive and improve our Global Design Controls processes.  

This position can be remote or be located in one of main US campus locations as a hybrid role.
 
Your responsibilities include:

• Supporting the organization’s transition to EU MDR by reviewing notified body feedback, assisting divisional product teams with submission responses, and acting on feedback trends by driving process improvement projects across the design controls sub-processes 
• Applying advanced analytical skills by evaluating both qualitative and quantitative data including synthesizing large data sets by identifying key themes/information 
• Demonstrated competency in implementing effective global design controls/risk management procedures to support the development of products to meet or exceed internal and external requirements.
• Influence key stakeholders through collaborative community engagement.  Help to connect the key SMEs across divisions and capitalize on networking skills to promote best practice sharing and efficient problem solving
• Support internal and external audits and audit responses to existing products. 
• Monitors compliance with company policies and procedures.
• Global CAPA ownership, particularly proven experience with complex, multi-site / multi-division problem-solving 
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Ensure the development and execution of streamlined business process which help achieve VIP/Continuous Improvement goals.

Required qualifications:

• Bachelor's degree and 7+years of Medical Device design controls and risk management experience
• Understanding of US and International regulations including 21 CFR, 820, and ISO 13485 is required, as well as the Medical Device Directive, EUMDR, and EN ISO 14971. Experience with IEC 62366 and/or IEC 60601 strongly desired. 
• Strong communication (oral and written) and presentation skills.
• Strong project management skills 
• Familiar with Microsoft Office Suite (Excel, PPT, Word)

Preferred qualifications:

• Degree in Science, Health, or Engineering related field.
• Experience with Usability Engineering, Capital Equipment, and/or Software highly desired. 

#LI-Remote

Requisition ID: 557101

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!

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.

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.