Boston Scientific Senior Design Quality Engineer 

United States, Massachusetts, Marlborough 

326605407

Your responsibilities include:

• Creative and resourceful problem-solving skills for moderate to complex mechanical and electrical devices.
• Ability to assist with troubleshooting, to the component level, moderate to complex mechanical assemblies.
• Working within a team of Sustaining Engineers (embedded within R&D and Quality Assurance groups).
• Actively contributing to all aspects of Design Quality Assurance activities in an FDA/EUMDR-Regulated Class II Medical Device Software environment including interconnected systems.
• Support the design, development, and test of finished devices and accessories used in Boston Scientific Endoscopy product lines during their entire Development Life Cycle, from the Requirements gathering phase to the End-of-Life phase.
• Participate in product, system, and sub-system level design reviews with focus on device design evaluation, product risk mitigation, and other required Risk Management activities.
• Support the creation and execution of validation protocols to perform sub-system and system level testing of our products and report any issues discovered.
• 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).
• Creation and review of DQA documentation as required (e.g., Hazard Analysis, Design Failure Modes and Effects Analysis, Design Validation and Usability Engineering related documentation).
• Become a Subject Matter Expert (SME) for design controls and risk management requirements for the products supported.
• Support all aspects of DQA activities during internal and external audits, as needed.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• May perform other duties as directed

What we’re looking for in you:
Required Qualifications

• Bachelor's degree in Biomedical, or Mechanical Engineering, or equivalent technical discipline.
• Minimum of 5 years of medical device engineering experience
• Working knowledge of the FDA, ISO, EUMDR and the medical device industry quality requirements associated with product development, design controls, product risk management, usability engineering and medical device software.
• 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.
• Strong communication and presentation skills.
• Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent).
• Ability to collaborate and work on a global team.
• Position located in Marlborough, MA or Coyol, Costa Rica
• Travel approximately 10-15% of the time

Preferred Qualifications

• Master's degree in Biomedical, or Mechanical Engineering preferred.
• 6+ years of medical device engineering experience preferred with 2+ years’ experience with medical device systems experience.
• Working familiarity with FDA QSR, EN ISO 13485, EN ISO 14971, and IEC 60601

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.