Senior Design Quality Engineer Urology

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance

At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About the role:
We have an exciting opportunity open for a Senior Design Quality Engineer who will support our sustaining Prosthetic Urology franchise. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential and product development experience. This role will apply the directives of design controls supporting product development design changes regulatory and standards compliance corrective and preventive actions identifying improvements for manufacturability and cost-reduction efforts. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Work mode:

At Boston Scientific we value collaboration and synergy. This hybrid role is based in Minnetonka MN and requires being on-site at least three days per week.

*This position will start off at our Minnetonka MN facility but will be transferred to our Maple Grove MN sometime in 2026.

Relocation assistance:

Relocation assistance is not available for this position at this time.

Visa sponsorship:

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

Your responsibilities will include:

• Support the execution and documentation of Design Validation & Verification and Usability activities
• Apply sound systematic problem-solving methodologies in identifying prioritizing communicating and resolving quality issues.
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
• Own and maintain product risk management tools (i.e. Hazard Analysis Fault Tree FMEAs).
• Good knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e. Design Change Analysis Design Inputs Design Outputs Test Methods Design Reviews Design V&V Usability Testing SW Validation Process Validation and Labeling).
• Lead and support cross-functional root-cause analysis investigation and resolution activities.
• Leads/provides support in the execution and investigation of CAPAs NCEP Failure Mode Investigations etc.
• Directly interfaces with internal and external audit activities
• Reviews and approves operational test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Support regulatory submissions to notified bodies.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

What were looking for in you:

Required qualifications

• Bachelors degree in chemical engineering Biomedical Engineering or related engineering field
• 5 years of experience in design assurance quality new product development or sustaining related medical device / regulated industry experience
• Detailed understanding of US and International regulations including 21 CFR 820 is required as well as the Medical Device Directive EN ISO 13485 and EN ISO 14971.
• Independently leads quality deliverables and supports decision-making with little supervision
• Adaptable and effective collaborator in a team environment and in self-directed work
• Strong communication skills (verbal & written)

Preferred qualifications

• Demonstrated use of Quality tools/methodologies
• Experience with pharma/combination devices with working understanding of US regulations including 21 CFR 210 211 and 11 is preferred.

Requisition ID:621351

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 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) isnt just business its personal. And if youre 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 Companys policies or protocols change with regard to COVID-19 vaccination.

Among other requirements Boston Scientific maintains specificprohibited substancetest 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.