Engineer, Sr Quality

Recruiter: Spencer Gregory Hale

Sr. Design Quality Engineer 

About the role:

This position is an opportunity to work for a worldwide and diverse company who puts patients first. Through this position, the ideal candidate develops, establishes and maintains quality engineering methodologies, systems, and practices which meet Boston Scientific (BSC), customer, and regulatory requirements.   Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.  Provides focused quality engineering support within sustaining, operational, or system/services support.

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:
Minimum Qualifications

• BS in Biomedical, or Mechanical Engineering, or equivalent technical discipline.
• Minimum of 5 years of medical device engineering or regulated industry 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

• MS 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 

Requisition ID: 564243