Senior Design Quality Engineer - Electrophysiology

Boston Scientific; Arden Hills (MN, CA); Hybrid; USD 80,000 - 158,000; Full time

Job summary

Boston Scientific is seeking a Senior Design Quality Engineer for the Electrophysiology space. The role leads design assurance across hardware, software, and system domains, ensuring product safety and regulatory compliance.

Based in a hybrid setup, Montreal preferred, with on-site presence at least 3 days/week. Candidates in Marlborough, MA; Waltham, MA; or Arden Hills, MN may also be considered, relocation assistance may be available.

Qualifications

• Bachelor’s degree in engineering or related technical discipline.
• 6+ years of experience in Quality Assurance, Design Assurance, Software Quality, or related roles in medical device industry.
• Experience with Design Controls, ISO 14971, 21 CFR 820, and ISO 13485.
• Proven ability to independently lead complex product development projects including software and system QA activities.
• Experience maintaining risk documentation such as FMEAs and Hazard Analyses.
• Strong problem-solving with CAPA investigations and root cause analysis.
• Excellent communication, able to influence stakeholders and lead cross-functional initiatives.
• Thrives in fast-paced environments with ambiguity and good judgment.

Responsibilities

• Serve as the technical authority within Quality for system integration, design decisions, risk management, and software development & validation.
• Lead design control activities for Capital Equipment, including planning, risk management, verification, and validation.
• Collaborate with R&D, regulatory, manufacturing and clinical teams on design and compliance throughout the product lifecycle.
• Own and maintain risk management files (Hazard Analysis, FMEAs) covering hardware, software and system risks.
• Lead root cause investigations and CAPA/NCEP/complaints with corrective actions.
• Incorporate post-market experience into risk management and design controls.
• Mentor junior engineers on design assurance and regulatory requirements.
• Identify gaps and drive continuous improvement in processes and documentation.
• Act as primary contact for audits and regulatory inspections.
• Manage multiple priorities and influence teams toward quality-centric decisions.

Skills

Quality Assurance

Design Assurance

Risk Management

CAPA investigations

Root cause analysis

Regulatory knowledge

Cross-functional collaboration

Mentoring juniors

Leadership

Audits

Education

Bachelor’s degree in Mechanical, Electrical, Software or Biomedical Engineering

Tools

IEC 62304

Design Controls tools

Risk management tools (FMEA)

Job description

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Senior Design Quality Engineer - Electrophysiology

Onsite Location(s): Arden Hills, CA

Additional Location(s):Canada-QC-Montreal; US-MA-Waltham; 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:

We have a high-impact opportunity for a Senior Design Quality Engineer to lead design assurance efforts for a critical medical device in the Electrophysiology space. This role requires a self-driven professional capable of independently managing complex technical challenges and driving to solutions across hardware, software, and system domains. The Senior Engineer will influence strategic quality initiatives, mentor junior engineers, and serve as a key resource in cross-functional teams to ensure product safety, regulatory compliance, and design robustness.

At Boston Scientific, we value collaboration and synergy. This hybrid role is preferably based in Montreal, Canada, with on-site presence required at least three (3) days per week. Candidates based in Marlborough, or Waltham MA or Arden Hills, MN may also be considered.

Relocation assistance:

Relocation assistance may be available for this position at this time.

Your responsibilities will include:

• Serve as the technical authority within Quality for system integration, design decisions, risk management, and software development & validation.
• Independently lead design control activities for the Capital Equipment, including Design & Development planning, risk management, design verification, and validation efforts, with a strong focus on robustness of system design and documentation.
• Collaborate closely with R&D, regulatory, manufacturing, and clinical teams to provide expert guidance on design and compliance matters throughout the product lifecycle.
• Own and maintain comprehensive risk management files (Hazard Analysis, FMEAs), ensuring robust coverage of both hardware, software, and system risks, applying advanced risk mitigation strategies to influence robust design decisions
• Lead root cause investigations and resolution of test failures, CAPAs, NCEPs, and complaints, driving corrective actions and preventive measures with minimal oversight.
• Ensure post-market experience is effectively incorporated into risk management and design controls through assessment of observed versus anticipated failure modes, harms, severity, occurrence, and effectiveness of existing risk controls.
• Provide mentorship and guidance to junior engineers on design assurance best practices, regulatory requirements, and quality processes.
• Proactively identify gaps and opportunities for continuous improvement in product development processes, tools, and documentation.
• Act as a primary point of contact for design assurance during internal and external audits and regulatory inspections.
• Effectively manage multiple priorities and projects independently, demonstrating strong decision-making skills in ambiguous situations, and ability to influence project team towards quality-centric decisions and behaviors

What we’re looking for:

Required Qualifications

• Bachelor’s degree in Mechanical, Electrical, Software Engineering, Biomedical Engineering, or related technical discipline.
• 6+ years of experience in Quality Assurance, Design Assurance, Software Quality, or related roles in the medical device industry.
• Demonstrated expertise in Design Controls, Risk Management (ISO 14971), Quality System Regulations (21 CFR 820), and Quality management systems (ISO 13485).
• Proven ability to independently lead complex product development projects, including software and system quality assurance activities, from inception through completion.
• Experience developing and maintaining risk documentation such as FMEAs and Hazard Analyses with hardware, software and system focus.
• Strong problem-solving skills with experience leading root cause analysis and CAPA investigations.
• Excellent communication skills, capable of influencing stakeholders at all levels and leading cross-functional initiatives.
• Ability to thrive in a fast-paced environment and navigate ambiguity with sound judgment.

Preferred Qualifications

• Experience mentoring or leading junior engineers in design assurance or software/systems engineering activities.
• Experience with Capital Equipment
• Knowledge of software quality standards (IEC 62304) and software/system development principles.
• Prior experience working on or supporting cardiac mapping systems or similar complex medical device platforms.
• Strong project management skills and familiarity with agile development methodologies.

Requisition ID:635692

Minimum Salary:$79700

Maximum Salary: $158200

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, oncologicaland 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.

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