Quality Engineer I - Electrical

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.

 

Boston Scientific is a worldwide and diverse company that puts patients first. Through this position, an engineer will use their systems engineering and risk management knowledge to support, develop, establish, and maintain Medical Electrial Equipment/Systems (MEE/MES) for New Product Development (NPD) and Sustaining Engineering within the Endoscopy Division of Boston Scientific.

 

About the role:

 

This Design Quality Assurance Engineer I - Electrical role will 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.

 

An engineer in this role will employ creative and resourceful problem-solving skills while working with moderate to complex mechanical and electrical devices. Methodologies in identification, prioritization, and communication are employed to aid in resolving quality issues. This position will utilize best practices in engineering to lead efforts for requirements development/management of system architecture to align risk mitigations with design inputs and design outputs at various levels (e.g., system/sub-system) for products that are both stand-alone and/or network connected.

 

Your responsibilities will include:

 

• 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

 

Required qualifications:

 

• Bachelor of Science in Electrical Engineering or Bachelor of Science in Mechanical, Biomedical, or other Engineering degree with a minor in Electrical Engineering (or equivalent electrical experience)
• Strong communication and presentation skills
• Competent with use of Microsoft Office Suite
• Ability to collaborate and work on a global team
• Hybrid position located in Marlborough, MA, USA; must be able to perform work duties onsite at least 3 days per week

 

Preferred qualifications:

 

• MS degree preferred
• Familiarity with IEC 60601-1, IEC 60601-1-2 and/or IEC 62304
• Minitab Statistical Analysis software (or equivalent)
• 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

 

Requisition ID: 584473

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