Boston Scientific Senior Design Quality Engineer 

United States, Minnesota 

496415653

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.

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

Maximum Salary: $ 156900

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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 test 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.