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

Your responsibilities will include:

• 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.

What we’re looking for in you:

Required 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).
• 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.

Preferred qualifications:

• 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.