Boston Scientific Systems Test Engineer II 

United States, Minnesota, Maple Grove 

840449444

The Systems Test Engineer is a Design Quality Engineer that directly supports medical device product development from concept through commercialization. Employee will work with high-performance cross-functional sustaining team to ensure safety, quality and compliance of launched products while continuously improving their commercial value through end-of-life. This position will focus on test method and equipment development to satisfy product requirements.
Your responsibilities include:

• Actively promote and participate in a cross-functional teamwork environment.
• Independently make decisions and work without constant supervision. Prioritizing tasks and projects, without direct oversight.
• Develop test equipment to satisfy product requirements for design verification from concept to functional equipment.
• Write various technical documentation for procedure execution, technical rationale and evidence of the development process.
• Support development and coordinate the execution of Design Validation and Verification activities.
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support the verification, validation, and usability testing to meet or exceed internal and external requirements
• Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
• Understanding human anatomy and physiology and be able to apply that knowledge to the usage of medical devices.
• Mentor cross functional team through product development process; specifically, with respect to design control and risk management deliverables.

What we’re looking for:
Required qualifications:

• Bachelor’s degree in Biomedical or Mechanical Engineering or related field of study
• 3+ 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
• Hands-on approach to product development
• Experience using SolidWorks 3D Modeling Software or equivalent
• Strong communication skills (verbal & written)
• Demonstrated use of Quality tools/methodologies
• ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
• Travel as required (10%)

Preferred qualifications:

• Previous development of testing and/or automated equipment
• Previous experience with Measurements System Analysis
• Experience integrating data acquisition equipment and clinically relevant simulated environments
• Experience using Minitab statistical software
• Experience using Matlab programming language
  

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement/ The foal 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.