Senior Design Quality 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 the role:
Join our Interventional Cardiology Team, where we create innovative technologies to diagnose and treat cardiovascular disease. Our products improve patient outcomes and enhance lives by providing the most advanced and broadest set of therapy solutions.

We are thrilled to be developing a new platform technology to treat calcified artery disease. We are looking for a dynamic Senior Design Quality Engineer to provide focused quality engineering leadership for single use devices for use with medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of Boston Scientific. 

This role offers a unique chance to work on the integration of innovative technologies, gain end-to-end exposure to the product development cycle, and excel in a dynamic, fast-paced environment. If you are passionate about advancing Medtech device product development and making a significant impact, let’s connect and explore this exciting opportunity together!
Design Quality drives the ISO14971 risk management process and the Verification & Validation (V&V) process. This includes quality plans, risk management plans and reports, hazard analysis, design FMEA, analysis of use error (task analysis), sampling systems / procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports. This Senior level role involves influencing and executing functional plans and collaborating with cross-functional teams and will be responsible for ensuring quality and compliance through integration, product development, and commercialization.

Your responsibilities will include

• Execution & strategy of deliverables such as Design and Development Planning, Risk Management, Design Verification and Validation, Usability Validation plans, Design Review, Field Assessment, Design Change, and NCEP/CAPA/PIR
• Effectively communicates within project team, across functions, and elevates issues above the project team as appropriate
• Develops solutions to technical problems. Investigate failure modes, perform root cause analyses, and develop solutions to address technical challenges. Ensure compliance with relevant regulatory requirements and standards
• Execute cross-functional plans, provide feedback to overall project strategy, knows when to solicit feedback, and facilitate project decisions to ensure successful product development and integration
• Builds quality into all aspects of work by maintaining compliance to all quality requirements, defending work, as well as support internal & external regulatory audits
• Author and review design documentation, including technical reports, design history files, design verification protocols/reports and regulatory submissions. Present project updates and technical insights to stakeholders.

What we're looking for in you
Required qualifications:

• Bachelor’s degree in mechanical, electrical, biomedical, chemical engineering, or related discipline 
• 4+ years of related experience in design assurance, new product development, or related medical device or regulated industry experience
• Experience with Risk Management Standard ISO 14971
• Experience with class III medical devices
• Experience with reliability testing
• Demonstrated use of Quality tools/methodologies
• Strong technical knowledge, problem-solving abilities, collaborative mindset, and effective communication skills

Preferred qualifications:

• An independent critical thinker; willingness to challenge status quo
• Understanding of electrical safety standards IEC 60601
• Previous experience with product integrations
• Strong knowledge of QSR and ISO standards
   

Requisition ID: 601634 

Minimum Salary: $ 82600 

Maximum Salary: $ 156900 

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 identify, 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.