Design Assurance Engineer II

Location

Maple Grove, MN | United States

Job description

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:
We have an exciting opportunity to join the Peripheral Interventions Design Assurance team supporting the TheraSphere device.  This Design Assurance Engineer II will be dedicated to advancing the treatment of liver cancer, TheraSphere is a catheter-based, loco-regional radiation therapy.  The Design Assurance Engineer II develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.  The Design Assurance Engineer II will provide focused quality engineering support for sustaining and new product development to ensure the delivery of the highest quality product to the customer.

Your key responsibilities will include:

• Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, Supplier Needs, and Manufacturing Input.
• Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
• Actively support the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
• Monitor field performance of established medical devices against risk assessments in support of Post – Market activities.  Analyze these data and identify areas of product design to proactively improve field performance.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Update and maintain Design History File, Design Input / Output, and Risk documentation.
• Acts as team member in supporting quality disciplines, decisions, and practices.

Required Qualifications:

• Minimum of a Bachelor’s degree in Biomedical Engineering, Mechanical Engineering or related field of study
• Minimum of 2 years of related experience

Preferred Qualifications:

• Medical device experience
• Focus on detailed work with emphasis on accuracy and completeness
• Ability to collaborate with cross functional teams
• Strong communication (oral and written) and presentation skills
• High energy problem solver capable of driving items to closure

Job tags

Salary