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

 

 

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

 

 

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

 

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 CDx products
• Develops and maintains the CDx risk management best practices including benchmarking with industry leaders, BSC product lines and as a member of the BSC Risk Management CoP. 

 

Required 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 II or 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, IEC 62304, MDD, 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

 

 

 

 

 

Requisition ID: 607580 

Minimum Salary: $ 82600 

Maximum Salary: $ 156900 

 

The anticipated compensation listed above and the value of core and optional emp