Boston Scientific Design Quality Assurance Engineer III - Marlborough 

United States, Massachusetts, Marlborough 

438094332

- Marlborough, MA

About the Role:

At Boston Scientific, the Design Quality Assurance Engineer III directly supports medical device product development from concept through commercialization. This individual will work with a high-performance cross-functional development team to ensure safety, quality and compliance of launched products while continuously improving their commercial value. Initially, this position supports the transition of the current commercial portfolio to meet European Union Medical Device Regulation (EUMDR) requirements. This position is part of the design site for the Endoscopy division and can support activities including but not limited to New Product Development, Sustaining and Life Cycle Management and Quality Systems initiatives as they relate to design and development.

Provides quality engineering support to operations, product development and sustaining projects for current products on the market. Develops, establishes, and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals, and priorities. Provides quality engineering support within technical development projects, new product development projects, sustaining existing product families, or system/services support.

This is a hybrid position based out of Marlborough, MA with the expectation to be in the office a minimum of three days per week.

Your Responsibilities Include:

• Identifies and implements effective risk management and process and design control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements. Specifically, in relation to achieving and continuity compliance to the EU MDR regulation.
• Creation and review of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode, and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA). Understand and support linkage of field data and Risk Management
• Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
• Function as key team member to the EU MDR transition team in updating and bringing Design History Files to state-of-the-art readiness including risk management and Post Market Surveillance activities.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e., 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies).
• Provide quality guidance to assure country specific compliance.
• Champion compliance to company policies, work instructions and SOPs.
• Checks and provides support in the execution and investigation of CAPAs, NCEPs, Failure Mode Investigations, etc.

Required Qualifications:

• BS in Mechanical, Electrical, Biomedical Engineering, or related degree.
• 3+ years of Medical Device engineering experience with BS, 2+ years with MS.
• Detailed understanding and working knowledge of the FDA, ISO, EUMDR and the medical device industry quality requirements associated with product development, design controls, product risk management, and usability engineering.
• Ability to collaborate and work on a global team.
• Competent with use of Microsoft Office Suite
• Travel approximately <10%

Preferred Qualifications:

• Strong communication (oral and written) and presentation skills.
• 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.
• Previous Experience in Problem Solving and CAPA methodologies.
• Minitab Statistical Analysis software experience (or equivalent).

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.