Design Quality Engineer III - Interventional Cardiology

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 currently recruiting for a Sustaining Design Quality Engineer III in our Arbor Lakes, MN location.  This is an exciting opportunity to participate in the quality assurance of our medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of BSC.     

 
The Design Quality Engineer III will support application of design controls to projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and improvements for manufacturability and cost reduction. This individual will work with a high performance cross-functional team to ensure safety, quality, and compliance of products.

Work mode:  

At Boston Scientific, we value collaboration and synergy. This hybrid role is based at the Arbor Lakes Campus in Maple Grove, MN and requires being on-site at least three (3) days per week.

Relocation assistance:

Relocation assistance may be 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:  

• Ownership of design change projects including scoping, assessment, and implementation.

• Develop, update, and maintain Design History File and Design Input / Output documentation

• Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.

• Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.

• Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• 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 we're looking for in you:
Required qualifications:

• Bachelor’s degree in an engineering discipline  

• Minimum of 3 years of experience in design assurance, quality, or related medical device or regulated industry experience

• Knowledge of basic Quality System Requirements and Good Documentation Practices

Preferred qualifications:

• Bachelor’s degree in mechanical, electrical, or biomedical engineering

• Experience with design control, risk management, and medical device standards compliance

• Experience with corrective and preventive action

• Adaptable and effective collaborator in a team environment and in self-directed work

• Strong communication skills (verbal & written) 

Requisition ID: 634497  

Minimum Salary: $ 78300  

Maximum Salary: $ 148800  

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see 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.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at and follow us on  LinkedIn .

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.