Senior Design Assurance Engineer CRM

Additional Location(s): US-MN-Arden Hills

The Senior Design Assurance Engineer will directly support medical device product development from concept through commercialization and sustainment within the Cardiac Rhythm Management and Diagnostics (CRMDx) division. This role will support the Design Quality Assurance team in a variety of quality-related activities on high-visibility issues and projects impacting active implantable and accessory devices, as well as combination products with a drug component and overall product performance.

This individual will collaborate and partner with Research and Development, Regulatory, Marketing, Medical Safety, Manufacturing, Post-Market, Acquisitions and Integrations, and other Quality organizations to achieve optimal results. The role is based in Arden Hills, Minnesota.

This position is an on-site role based in Arden Hills, Minnesota. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

• Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues.
• Act as an effective team member and mentor in supporting quality disciplines, decisions and practices.
• Support Design Assurance acquisition integration activities related to risk management remediation, Design Control Quality System integration and other Design Assurance integration priorities.
• Support verification, validation and usability testing activities to meet or exceed internal and external requirements.
• Develop, update and maintain Design History File and Design Input/Output documentation, including product specifications, component specifications and prints.
• Generate, update and maintain product risk management tools, including hazard analyses and FMEAs.
• Partner with Research and Development to determine and implement design controls based on risk management, customer needs and manufacturing input.
• Create, maintain and enhance cross-functional team partnerships. Provide guidance regarding technical strategies and approaches while working across functions and multiple sites to identify and resolve technical issues.
• Perform additional duties as required.

• Minimum Bachelor’s degree with a minimum of 5 years' experience, or Master’s degree with a minimum of 3 years' experience, in design assurance, new product development or related medical device experience. Degree must be in an engineering discipline or related field of study.
• Understanding of ISO 13485, ISO 14971 and Quality System Regulations, with a focus on design controls and risk management.
• Demonstrated experience using quality tools and methodologies.
• Hands-on experience and approach to product development.
• Willingness to travel up to 10%.

• Proven experience supporting quality integration activities.
• Boston Scientific experience preferred.
• Proven Risk management and ISO 14971 experience.
• Proven experience with Class III medical devices, including Electrical Medical Equipment or Active Implantable Medical Devices.
• Proven experience with products incorporating materials of animal origin.
• Proven experience with combination products that include a drug component.
• Proven ability to influence without direct authority.

Requisition : 628323

Minimum Salary: $85,000

Maximum Salary: $161,500

Compensation and Benefits: The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see —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.

At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales…