Senior Design Quality Engineer - Cardiac Rhythm Management & Diagnostics (CRMDx)

Boston Scientific Corporation; Arden Hills (MN); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific seeks a Senior Design Quality Engineer for Cardiac Rhythm Management & Diagnostics in Arden Hills, MN. This hybrid role requires three office days weekly and supports active implantable devices, collaborating with R&D, process development, manufacturing, and regulatory affairs to ensure safe, high‑quality products throughout the lifecycle.

You will own risk management, design controls, product performance, quality and compliance; maintain design history files and risk analyses;

Qualifications

• Bachelor's degree in engineering or related technical field.
• 5+ years in design assurance, new product development, or regulated medical device industry.
• Demonstrated use of quality tools/methodologies.
• Ability to work in mixed onsite + remote environment.
• Experience writing specifications, test protocols, and technical reports.

Responsibilities

• Owns and drives deliverables related to Risk Management, Design Controls, Product Performance, Quality, and Compliance.
• Develop, update, and maintain Design History File and Design Input/Output documentation.
• Generate and maintain product risk management tools (Hazard Analysis, FMEAs, etc.).
• Apply systematic problem-solving to identify and resolve quality issues.

Skills

Engineering degree

5+ years experience

Strong communication

Quality tools

Remote collaboration

Technical writing

Education

Bachelor's degree in mechanical/electrical/biomedical engineering

Job description

Select how often (in days) to receive an alert: Create Alert

Senior Design Quality Engineer - Cardiac Rhythm Management & Diagnostics (CRMDx)

Onsite Location(s):

Arden Hills, MN, US, 55112

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:
This Senior Design Quality Engineer position will support active implantable medical devices. This position will serve as a quality representative on product development projects and will collaborate with cross functional teams including R&D, process development, manufacturing, and regulatory affairs to help ensure that the product and processes remain safe, of high quality, and compliant with BSC and regulatoryrequirements throughout the product lifecycle process.

Work Mode:

Boston Scientific values collaboration, and this hybrid role requires employees to work from the Arden Hills, MN office at least three days per week.

Relocation Assistance:

Relocation assistance is not 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:

• Owns and drives deliverables related to Risk Management, Design Controls, Product Performance, Quality, and Compliance.
• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
• Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs).
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Acts as an effective team member in supporting quality disciplines, decisions, and practices.
• Work within a cross-functional team to identify and implement effective controls for new technology in complex medical devices.
• Write various technical documentation for procedure execution, technical rationale, and evidence of the development process.
• Develops and implements quality strategies; seeks innovative approaches to attain quality goals.
• Support Post Market activities, as necessary, of risk based on post-market signals.
• Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
• Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatoryrequirements and internal standards.
• Support the verification, validation, and usability testing to meet or exceed internal and externalrequirements.
• Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Partner cross-functionally to identify and support value improvement efforts to support business goals.
• Directly interfaces with internal and external audit activities.

What we’re looking for in you:
Required qualifications:

• Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline).
• 5+ yearsof experience in design assurance, new product development or related medical device / regulated industry experience.
• Self-motivated with a passion for solving problems and a bias for action.
• Strong communication skills (verbal & written).Effectively present complicated technical information to small and large audiences, from peers to senior leadership, with varying levels of technical expertise.
• Demonstrated use of Quality tools/methodologies.
• Ability to effectively work and collaborate in a mixed onsite + remote environment.
• Experience writing specifications, test protocols, and technical reports.

Preferred qualifications:

• Experience with Class III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD).
• ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis.
• Experienced problem solver, capable of facilitating the problem-solving process.
• Adaptable and effective collaborator in a team environment or in self-directed work.
• Experience with design changes, complaint reduction, and corrective action.

Requisition ID:636058

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 byprovidinga 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,neurologicaland 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 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.

Nearest Major Market: Minneapolis
Job Segment: Biomedical Engineering, Senior Quality Engineer, Compliance, Regulatory Affairs, Quality Engineer, Engineering, Legal