Senior Design Quality Engineer - Cardiac Rhythm Management & Diagnostics (CRMDx)

Boston Scientific • Arden Hills, MN

2d • $85,000 - $161,500 • Hybrid

About The Position

This Senior Design Quality Engineer position will support active implantable medical devices. This position will serve as a quality representative on product development projects and will collaborate with cross functional teams including R&D, process development, manufacturing, and regulatory affairs to help ensure that the product and processes remain safe, of high quality, and compliant with BSC and regulatory requirements throughout the product lifecycle process.

Requirements

• 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). Effectively present complicated technical information to small and large audiences, from peers to senior leadership, with varying levels of technical expertise.
• 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.

Nice To Haves

• Experience with Class III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD).
• 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.
• Adaptable and effective collaborator in a team environment or in self-directed work.
• Experience with design changes, complaint reduction, and corrective action.

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.
• Work within a cross-functional team to identify and implement effective controls for new technology in complex medical devices.
• 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.

Benefits

• Relocation assistance is not available for this position.
• Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.

What This Job Offers

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