Boston Scientific Design Assurance Engineer III 

United States, Minnesota, Maple Grove 

634906270

Your responsibilities will include:

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization
• Develop and execute electrical and software Design Verification (DV) test protocols
• Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices
• Develop, update, and maintain Design History File (DHF) and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
• 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

What we're looking for in you:
Required Qualifications:

• Bachelor’s degree in Computer Engineering, Electrical Engineering, or other related field of study
• Minimum of 3 years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience

Preferred Qualifications:

• ISO 13485, ISO 14971 and FDA Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
• Experience with design changes, complaint reduction, and corrective action
• Adaptable and effective collaborator in a team environment and in self-directed work
• Strong communication skills (verbal & written)
• Demonstrated use of Quality tools/methodologies
• Experience with JIRA and software quality

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.