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

Additional Location(s): N/A

About The Role

This Principal Design Quality Engineer position will support active implantable medical devices. This role collaborates with cross-functional teams including R&D, process development, manufacturing, and regulatory affairs to ensure that the product and processes remain safe, of high quality, and compliant with Boston Scientific (BSC) and regulatory requirements throughout the product lifecycle.

Work Mode: This hybrid role requires employees to work from the Arden Hills, MN office at least three days per week.

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.

Responsibilities

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Act 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.
• Support Design Assurance activities as related to Risk Management, Design Controls, and other DA-related priorities.
• Support Post Market activities, as necessary, of risk based on post-market signals.
• Actively participate in the Design Change process to ensure proposed changes to products are systematically 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 verification, validation, and usability testing to meet or exceed internal and external requirements.
• 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).
• 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 meet business goals.

Requirements

• Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline).
• 9+ 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.
• Demonstrated experience creating detailed technical documents.

Preferred Qualifications

• Experience working with medical electrical equipment and/or active implantables.
• 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.

Pay

Minimum Salary: $102,100
Maximum Salary: $194,000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

Benefits

For details on Boston Scientific’s employee benefits, visit www.bscbenefitsconnect.com.