Senior System Test Engineer

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.

Senior System 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 mechanical design and test equipment development to satisfy product requirements.

At Boston Scientific, we value collaboration and synergy. This role follows a onsite work model requiring employees to be in our local Maple Grove office five days per week.

Relocation assistance is available for this position.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• Actively promote and participate in a cross-functional teamwork environment.
• Lead development and coordinate the execution of Design Validation and Verification activities for large new product development projects.
• Independently make decisions and work with limited supervision. Take ownership of 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.
• 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.
• Guide cross functional team through product development process; specifically, with respect to design control and risk management deliverables.

Required qualifications

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering or related field of study
• 5+ 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
• 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%)

• 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

618320

$82600

$156900

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…