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Engineer II, Quality

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Onsite
Onsite Location(s): 

Marlborough, MA, US, 01752

Hiring Manager: Keith Mitchell Bishop
Recruiter: Spencer Gregory Hale

 

Design Quality Engineer II

 

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: Provide key quality trending information and data for Management Review and Complaint Reviews. Provide quality and compliance input and coaching for product development and/or 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, PIR’s and Field Actions. Support CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).

 

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.

 

Requisition ID: 557208


Nearest Major Market: Boston

Job Segment: Biomedical Engineering, Medical Device Engineer, Quality Engineer, Medical Device, Product Development, Engineering, Healthcare, Research

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