Senior Design Assurance Engineer - Electrophysiology

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

The Senior Design Assurance Engineer will serve as the quality/design assurance representative for new product development programs within the Pulse Field Ablation (PFA) catheter portfolio. This role partners closely with R&D, Systems, Clinical, Regulatory, Manufacturing/Operations, and Supplier Quality to ensure design control rigor, robust risk management, and objective evidence supporting safe and effective products from concept through commercialization.

Work mode:

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

Relocation assistance:

Relocation assistance is 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 implementation of design controls appropriate to program risk and phase; plan and execute phase-appropriate design assurance deliverables.
• Develop, review, and maintain Design History File (DHF) content including design inputs/outputs, traceability, and design review evidence.
• Provide design assurance subject matter guidance and independent review at defined milestones and design reviews.
• Own and maintain product risk management documentation (e.g., Risk Management Plan/Report, Hazard Analysis, DFMEA/PFMEA and related analyses as applicable), ensuring alignment with standards and internal procedures.
• Drive risk-based decision making, including documenting rationale for decisions and prioritization in ambiguous situations.
• Lead and support development and execution of design verification and validation strategy; coordinate protocol/report readiness, objective evidence, and traceability closure.
• Support usability/human factors activities as applicable, including inputs to use-related risk analysis, validation readiness, and documentation.
• Apply validation and statistical techniques to ensure methods and acceptance criteria meet regulatory expectations and internal standards.
• Lead and Support and, when needed, lead investigations related to NCEP/CAPA, complaints, and failure mode investigations, ensuring containment, root cause, and corrective actions are appropriate and documented.
• Ensure design changes, supplier/manufacturing variations, and risk impacts are assessed and documented within the design control framework.
• Partner cross-functionally with R&D, Project Management, Manufacturing, Regulatory, Clinical, and Marketing to ensure project execution and compliance to design control deliverables.
• Demonstrate commitment to patient safety and product quality through adherence to quality policy and procedures.

What we’re looking for in you:

Required qualifications:

• Bachelor’s degree in Engineering or related technical discipline (Mechanical, Biomedical, Electrical, Materials, Chemical, or similar).
• 5+ years of experience in Design Assurance, Quality Assurance, R&D, Manufacturing Engineering, or related work in medical devices or other regulated industries.
• Working knowledge and demonstrated application of design controls and risk management best practices.
• Working knowledge of ISO 13485, ISO 14971, and applicable Quality System Regulations (FDA QSR or equivalent).
• Proven ability to operate effectively in cross-functional teams and communicate clearly in written and verbal formats.

Preferred qualifications

• Experience supporting electrophysiology and/or cardiac mapping and ablation products or catheter-based therapies (e.g., PFA, RF, cryotherapy).
• Experience creating and maintaining risk documentation (e.g., FMEAs, hazard analyses) and using risk management tools (e.g., Stature, FMEA-MED or similar).
• Experience supporting design verification and validation method development, including test method validation and use of statistical techniques.
• Demonstrated strength in structured problem solving and leading cross-functional investigations.

Requisition ID: 622171

The anticipated annualized base amount or range for this full time position will be $ to $, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

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) isn’t just business, it’s personal. And if you’re 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 is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

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 testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.