Senior Design Quality Engineer - Interventional Oncology

Boston Scientific • Maple Grove, MN

16h • Hybrid

About The Position

Your responsibilities will include: Responsible for design control and risk management of next-generation medical devices Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines).

Requirements

• Minimum of a bachelor's degree in mechanical, electrical, or biomedical engineering (or other related technical discipline)
• Self-motivated with a passion for solving problems and a bias for action
• 5+ years of experience in design assurance, new product development or related medical device / regulated industry experience
• Strong communication skills (verbal & written)
• Demonstrated use of Quality tools/methodologies
• Ability to effectively work and collaborate in a mixed onsite + remote environment
• Demonstrated experience creating detailed technical documents
• Experience working with medical devices industry ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
• Experienced problem solver, capable of facilitating the problem-solving process
• Experience with technology acquisition & integration
• Experience with design changes, risk management, and corrective action

Responsibilities

• Responsible for design control and risk management of next-generation medical devices
• Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines)

What This Job Offers

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