Design Quality Engineer II

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:
We have an exciting opportunity to join the Design Quality team supporting the TheraSphere Y90 device. TheraSphere is a catheter-based, loco-regional radiation therapy. In this role, you will make important contributions to exciting new applications (TDP) and excel in a dynamic, fast-paced environment. This Design Quality Engineer II will work with high-performing cross-functional development teams to develop and maintain the design control deliverables, risk management analysis, and DHF compliance to ensure delivery of the highest quality product to the customer. 

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office three days per week.

Relocation assistance may be available for this position.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.

Your responsibilities will include:

• Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, Supplier Needs, and Manufacturing input.
• Understand clinical use cases and user interface requirements to drive design decisions and implement through the risk management package.
• Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
• Collaborate with R&D to ensure the design of test assemblies and test method parameters using current analysis techniques and technologies will allow for success in test method validation.  Independently drive the test method validation process as well. 
• Monitor field performance against risk assessments. Analyze these data and identify areas of product design to proactively improve field performance. 
• Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed. May include design and execution of structured experimental plans to drive data-based decisions informing the proposed change decision. 
• Support the verification, validation, and usability testing to meet or exceed internal and external requirements
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

What we’re looking for in you:

Required qualifications:

• Bachelor’s degree in an Engineering discipline 
• 2+ years of experience in design assurance, quality, or related medical device experience
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards
• Demonstrated use of Quality tools/methodologies
• Ability to collaborate and influence across multiple, cross-functional teams
• Strong communication skills (verbal and written)
• Hands-on approach to product development/improvement

Preferred qualifications:

• Comfort with self-directed work in addition to collaboration in a team environment
• Experience with design changes, complaint reduction, and corrective action 
• Strong ability to successfully multi-task and adapt

Requisition ID: 614571 

Minimum Salary: $ 69500 

Maximum Salary: $ 132000 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.

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