Senior Design Quality Assurance Engineer

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 this role:
The Senior Design Quality Engineer will serve on a high-performing, cross-functional product development team to design world-class Cardiac Rhythm Management (CRM) Systems in the Arden Hills location. You will lead the safety risk engineering activity including Hazard Analysis, Fault Tree Analysis, and Design Failure Modes and Effects Analysis (DFMEA).  This high visibility position provides excellent growth potential. 

Your responsibilities will include:

• Owns, creates, maintains and/or supports safety risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, and DFMEA
• Provides support to Design Quality Engineers on new product development and sustaining engineering projects
• Highly cross-functional in nature, this role consults with product experts, R&D, post-market quality, and medical safety functions for risk analysis across the life of Boston Scientific CRM products

Minimum qualifications:

• Bachelor’s degree in Electrical Engineering, Software Engineering, Systems Engineering, Mechanical Engineering, Biomedical Engineering, Material Science, or related discipline.
• 3+ years of experience in safety risk engineering, design assurance, post-market quality, or R&D.
• Experience developing or supporting complex, high-reliability systems in a regulated industry, including medical devices, pharmaceuticals, or aerospace.
• Demonstrated ability to work with cross functional team to solve complex engineering problems using analysis, experimentation, and statistics 
• Familiarity with risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, DFMEA, and Corrective and Preventive Actions (CAPA)

Preferred qualifications:

• Bachelor’s degree and 5+ years or Master’s degree with 3+ years of experience in safety risk engineering, design assurance, post-market quality, or R&D.
• Direct experience in risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, and DFMEA
• Experience developing Class III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD)
• Experience working with Regulatory Affairs in product submissions
• Strong mechanical, electrical, software, or systems aptitude
• Experience using quality tools and methodologies for design optimization including DFMEA, Design of Experiments (DOE), Brainstorming, Root Cause Analysis, 5 Whys
• Good Documentation Practice skills
• Understanding of regulations applicable to medical device design controls and risk management, including FDA 21 CFR 820, ISO 13485, EN ISO 14971, MDD, AIMD, and EU MDR
• Professional Certifications, including American Society for Quality Certified Quality Engineer
• Team player with a record of success in a fast-paced, dynamic environment
• Good communication and analytical skills

#LI-Hybrid

Requisition ID: 572950

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.  

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.