Boston Scientific is looking to hire a Design Quality Assurance Engineer I - Electrical to lead the effort to establish and maintain MEE/MES in partnership with a diverse and high-performing team. This role will require engineers to provide technical support for the integration of Single Use Devices (SUD) with MEE to form systems that will provide imaging solutions to facilitate further examination and/or delivery of therapy to the bile or pancreatic duct.
Requirements
- Bachelor of Science in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or another engineering degree with a minor in Electrical Engineering or equivalent electrical experience.
- Proficient with Microsoft Office tools, including Word, Excel, PowerPoint, and Outlook.
- Familiarity with IEC 60601-1, IEC 60601-1-2 and/or IEC 62304.
- Minitab Statistical Analysis software (or equivalent).
Responsibilities
- Provide insight to identify risks through all phases of Electrical Hardware design using quality assurance principles applicable to FDA/EUMDR-Regulated Class II Medical Device environments including the remediation of legacy commercialized products
- Create and maintain risk management and usability documentation such as the Hazard Analysis, Design Failure Modes and Effects Analysis (DFMEA), Task Analysis, and Fault Tree Analysis (FTA) while incorporating IEC 60601-1, IEC 60601-1-2 and/or IEC 62304 and Cybersecurity principles
- Manage MEE/MES suppliers to ensure Boston Scientific improves the quality of patient care and all things Boston Scientific
- Post-market surveillance for commercialized devices conducted through the support of trending and product performance, including the identification of signals and nonconformities
- Ownership of Nonconforming Events and Prevention (NCEP) and Corrective Action/Preventative Actions (CAPA); the use of analytics will be required to ensure patient care and product performance are not compromised
Other
- This role follows a hybrid work model requiring employees to be in our local office three days per week.
- This position may be eligible for relocation assistance.
- Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
- Focus on detailed work with emphasis on accuracy and completeness.
- Excellent organizational and planning skills; drives for results.
- High energy problem solver capable of driving items to closure.
- Ability to collaborate and work on a global team.
