Boston Scientific Senior Design Assurance Engineer 

United States, Minnesota, Maple Grove 

242271841

Your responsibilities include:

• Support the execution and documentation of Design Validation & Verification and Usability activities.
• 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, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications).
• Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
• Lead and support cross-functional root-cause analysis investigation and resolution activities
• Evaluate and support design test and inspection method development, and lead method validation activities
• Support regulatory submissions to notified bodies.
• 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.

What we’re looking for:
Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or related field of study
• 5+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
• Problem solver, capable of facilitating the problem-solving process
• Adaptable and effective collaborator in a team environment and in self-directed work
• Strong communication skills (verbal & written)
• Demonstrated use of Quality tools/methodologies

Preferred Qualifications

• Ability to work in a highly matrixed and geographically diverse business environment

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

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.