Senior Design Quality Engineer

Boston Scientific • Maple Grove, MN

13h

About The Position

Responsibilities include product development, remediation, and distribution of acquired products. Your responsibilities will include: Develops integration strategies and approaches relating to Design Controls, Risk Management, and other areas of the Quality System as required. Delivers and manages completion of functional deliverables, including updates to documents, procedures, and knowledge sharing documents as required. Investigates, identifies, and implements best-in-class Quality Engineering practices as requested by management. Advises management on potential improvements or enhancement to quality systems and processes in the company. Assists in identifying and developing tools that facilitate BEST4 processes

Requirements

• Bachelor's degree in Science, Health, or Engineering
• Minimum of 5 years of related work experience in the medical device regulated industry.
• Working knowledge of US and International regulations and standards applicable to BSC including 21 CFR 806 & 820, ISO 13485, ISO 14971, EUMDR, CMDR, and MDSAP.
• High energy problem solver capable of driving items to closure.
• Strong presentation & communication skills.
• Computer skills required including Excel, Word, and PowerPoint.
• Potential global and US travel up to 40%.
• > 3 years of experience working on acquisitions.
• > 3 years working with Active Implantable devices.
• > 3 years working with Capital Equipment.
• Experience within BSC quality systems.
• Project Management Experience
• Experience working with functions such as Operations, Regulatory, Research and Development, Clinical, and Quality.

Responsibilities

• Develops integration strategies and approaches relating to Design Controls, Risk Management, and other areas of the Quality System as required.
• Delivers and manages completion of functional deliverables, including updates to documents, procedures, and knowledge sharing documents as required.
• Investigates, identifies, and implements best-in-class Quality Engineering practices as requested by management.
• Advises management on potential improvements or enhancement to quality systems and processes in the company.
• Assists in identifying and developing tools that facilitate BEST4 processes

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level