Design Quality Engineer III

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 the role: 

Boston Scientific is a worldwide and diverse company who puts patients first. As an industry leader in kidney stone management, the Urology divisional team is on a mission to provide urologists with products that offer the best quality, functionality, and flexibility he/she/they need to treat their patients. As a Design Quality Assurance Engineer III, you’ll be at the heart of that mission by working with high-performing cross-functional teams to primarily focus on Value Improvement Projects (VIPs) which are intended to continually improve the quality, delivery, and cost of Core Stone products. He/she/they will serve as a Quality representative who can directly impact patient care by ensuring the safety, quality, post market performance and compliance of the Urology franchise products are maintained while continuously improving their value. He/she/they will interface with cross-functional teams to complete sustaining projects, design control deliverables, and activities to ensure our products continue to meet state of the art regulatory standards and user needs.

  
Your responsibilities include: 

• Effectively works with and influences cross-functional teams during the Design Change process to ensure proposed changes to products are systemically / thoroughly analyzed, assessed, controlled and implemented appropriately (i.e., EN 13485 / CFR820).
• Work with cross functional team members on Value Improvement Projects (VIPs) which are intended to continually improve the quality, delivery, and cost of BSC products.
• Support Risk Management planning, updating and maintenance of the product risk documentation (Hazard Analysis, Design FMEA, Task Analysis and Fault Tree Analysis, etc.) in compliance with Boston Scientific procedures and external standards (eg. EN 14971).     
• Support Usability Engineering and planning documentation (eg. EN 62366/ISO 62366) 
• Interface with the core team and support the sustaining effort for both product and packaging designs. 
• Interface with the core team and support manufacturing operation efforts / changes to ensure they meet or exceed internal and external requirements. 
• Apply sound, systematic problem-solving methodologies (e.g., 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies) in identifying, prioritizing, communicating, and resolving quality issues. 
• Supporting post market activities ensuring our products meet patient, customer, product performance, and quality system expectations through risk-based assessment of post-market signals.
• Support internal and external regulatory audits as required.

  
What we’re looking for in you: 
Required Qualifications:

• BS in Engineering (Biomedical, Electrical, Software or equivalent).  
•  3-6 years of related experience.  
• Travel approximately <10%
• In depth familiarity with the FDA, ISO, MDD, and the medical device industry quality requirements associated with product design & development and product risk management.  
• Ability to work in a fast paced, dynamic environment while promoting / fostering cross-functional teamwork.
• Detailed understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, and EN ISO 14971.  
• High energy problem solver capable of driving items to closure.  
• Strong communication (oral and written) and presentation skills.  
• Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).  
   

Requisition ID: 587028

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 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 prohibited substance 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.