Senior Design Assurance Engineer CRM

Work mode: Onsite

Onsite Location(s):

Arden Hills, MN, US, 55112

Additional Location(s): US-MN-Arden Hills

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 was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work. Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

The Senior Design Assurance Engineer will directly support medical device product development from concept through commercialization and sustainment within the Cardiac Rhythm Management and Diagnostics (CRMDx) division. This role will support the Design Quality Assurance team in a variety of quality-related activities on high-visibility issues and projects impacting active implantable and accessory devices, as well as combination products with a drug component and overall product performance.

This individual will collaborate and partner with Research and Development, Regulatory, Marketing, Medical Safety, Manufacturing, Post-Market, Acquisitions and Integrations, and other Quality organizations to achieve optimal results. The role is based in Arden Hills, Minnesota.

Work model, sponsorship, relocation:

This position is an on-site role based in Arden Hills, Minnesota. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues.
Act as an effective team member and mentor in supporting quality disciplines, decisions and practices.
Support Design Assurance acquisition integration activities related to risk management remediation, Design Control Quality System integration and other Design Assurance integration priorities.
Support verification, validation and usability testing activities to meet or exceed internal and external requirements.
Develop, update and maintain Design History File and Design Input/Output documentation, including product specifications, component specifications and prints.
Generate, update and maintain product risk management tools, including hazard analyses and FMEAs.
Partner with Research and Development to determine and implement design controls based on risk management, customer needs and manufacturing input.
Create, maintain and enhance cross-functional team partnerships. Provide guidance regarding technical strategies and approaches while working across functions and multiple sites to identify and resolve technical issues.
Perform additional duties as required.

Required qualifications:

Minimum Bachelor’s degree with a minimum of 5 years' experience, or Master’s degree with a minimum of 3 years' experience, in design assurance, new product development or related medical device experience. Degree must be in an engineering discipline or related field of study.
Understanding of ISO 13485, ISO 14971 and Quality System Regulations, with a focus on design controls and risk management.
Demonstrated experience using quality tools and methodologies.
Hands-on experience and approach to product development.
Willingness to travel up to 10%.

Preferred qualifications:

Proven experience supporting quality integration activities.
Boston Scientific experience preferred
Proven Risk management and ISO 14971 experience.
Proven experience with Class III medical devices, including Electrical Medical Equipment or Active Implantable Medical Devices.
Proven experience with products incorporating materials of animal origin.
Proven experience with combination products that include a drug component.
Proven ability to influence without direct authority.

Requisition ID: 628323

Minimum Salary: $ 85000

Maximum Salary: $ 161500

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.

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 www.bostonscientific.com 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.

Nearest Major Market: Minneapolis
Job Segment: Medical Device, R&D Engineer, Medical Device Engineer, Compliance, R&D, Healthcare, Engineering, Legal, Research

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