Senior Design Quality Engineer — Cardiac Implants

Boston Scientific; Arden Hills (MN); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific is seeking a Senior Design Quality Engineer to support active implantable medical devices. The role focuses on risk management, design controls, and product quality across development and post-market activities.

Hybrid work from Arden Hills, MN with collaboration across R&D, manufacturing, and regulatory teams. The ideal candidate has a strong track record in regulated medical devices, excellent communication, and experience writing specifications, reports, and test protocols.

Qualifications

• Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline).
• 5+ years of experience in design assurance, new product development or related medical device / regulated industry experience.
• Self-motivated with a passion for solving problems and a bias for action.
• Strong communication skills (verbal & written).
• Demonstrated use of Quality tools/methodologies.
• Ability to effectively work and collaborate in a mixed onsite + remote environment.
• Experience writing specifications, test protocols, and technical reports.

Responsibilities

• Owns and drives deliverables related to Risk Management, Design Controls, Product Performance, Quality, and Compliance.
• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
• Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs).
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Acts as an effective team member in supporting quality disciplines, decisions, and practices.
• Write various technical documentation for procedure execution, technical rationale, and evidence of the development process.
• Develops and implements quality strategies; seeks innovative approaches to attain quality goals.
• Support Post Market activities, as necessary, of risk based on post-market signals.
• Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
• Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards.
• Support the verification, validation, and usability testing to meet or exceed internal and external requirements.
• Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Partner cross-functionally to identify and support value improvement efforts to support business goals.
• Directly interfaces with internal and external audit activities.

Skills

Quality tools/methodologies

Communication skills

Problem solving

Team collaboration

Education

Bachelor's degree in mechanical/electrical/biomedical engineering

Job description

Boston Scientific is seeking a Senior Design Quality Engineer to support active implantable medical devices. The role focuses on risk management, design controls, and product quality across development and post-market activities.

Hybrid work from Arden Hills, MN with collaboration across R&D, manufacturing, and regulatory teams. The ideal candidate has a strong track record in regulated medical devices, excellent communication, and experience writing specifications, reports, and test protocols.