Boston Scientific Design Quality Assurance Engineer II 

United States, Massachusetts, Marlborough 

678405747

About the role:

Provides quality engineering support as part of a new product development team. 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 two days per week.
Your responsibilities include:

• 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).
• 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
• 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.
• Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
• Support effective quality assurance, process controls and metrics using data and statistical analysis to drive improvements and actions for manufacturing and assembly of products.
• Provide quality and compliance input for post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP’s, CAPA’s PIRs, Field Signals Evaluations and Field Actions.
• Support internal and external regulatory audits as required.

Required qualifications:

• BS in Mechanical, Electrical, Biomedical Engineering, or related degree.
• 2+ years with BS, 1+ years with MS of Medical Device engineering experience.
• Detailed understanding and working knowledge of US and International regulations including 21 CFR part 820, is required, as well as the Medical Device Directive / Medical Device Regulation, EN ISO 13485 and EN ISO 14971.
• Travel approximately <10%

Preferred qualifications:

• Electrical Medical Device experience and working knowledge of IEC 60601
• Experience in design controls and development of DHF deliverables. Understanding of interdependencies between design documentation ranging from Hazard Analysis, Task Analysis, Design Requirements, Design Controls, Design Verification and Design Validation/Usability.
• Strong communication (oral and written) and presentation skills.
• Ability to collaborate and work on a global team.
• 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.
• Minitab Statistical Analysis software (or equivalent).
  

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.

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.