Boston Scientific Design Quality Engineer II 

United States, Massachusetts, Marlborough 

97818440

Spencer Gregory Hale

About this role:
A Design Assurance Quality Engineer II is responsible for assuring all requirements are established and maintained for commercialized products per the Product Development, Risk Management, Design Controls and Post Market Surveillance processes. Works in fast paced Cross-Functional Sustaining Engineering Teams, helping to ensure the technologies remain state of the art.

Your responsibilities include:

• Execute Quality Deliverables: Drive the execution of Quality Deliverables such as Project Design & Development Plan, Field Assessment Plan, and Design Change Assessment. Supports the execution of the Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety. Lead product usability and design validation efforts for new product development and design change projects.
• Design Controls:Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Product Specifications, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling) whether internal, co-developed or externally manufactured. Provides guidance to assure country specific compliance to the laws and regulations of the targeted market for distribution
• Manufacturing Engineering:Provide product specific manufacturing and co-development quality assurance expertise during audits, and through approval of manufacturing PDP and Design Controls deliverables. Measure and oversee the real-time continued quality of internal and external Component and Finished Good Suppliers.

• Audit Support: Support internal and external regulatory audits.

• Product Support:

What we’re looking for in you:
Minimum Qualification

• BS in Mechanical, Electrical, or Biomedical Engineering
• Minimum of 2 years of medical device engineering experience;
• Travel approximately 10-15% of the time
• In depth familiarity with the FDA, ISO, MDD and the medical device industry quality requirements associated with product development, design controls, and product risk management.
• Detailed understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971, and EN 62366.
• Strong communication and presentation skills.
• Competent with use of Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).

Preferred Qualifications

• 3+ years of medical device engineering experience preferred.

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to aprohibited substancetest as a requirement. The goal of theprohibited substancetesting is to increase workplace safety in compliance with the applicable law.