Senior System Test Engineer

About the role:

Senior System Test Engineer is a Design Quality Engineer that directly supports medical device product development from concept through commercialization. The employee will work with a 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 focuses on mechanical design and test equipment development to satisfy product requirements.

On site. This role follows an onsite work model requiring employees to be in our local Maple Grove office five days per week.

Relocation assistance:

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.
• Apply 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.
• Understand 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.

• 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 Solid Works 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%).

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

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain U.S. 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.

This role is deemed safety‑sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.