Boston Scientific Field Clinical Representative II - Indianapolis 

United States, Indiana, Indianapolis 

90598445

About the role:
Senior System Test Engineer is a Design Quality Engineer thatdirectly 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 in electrical and software development to satisfy product requirements.

Your responsibilities include:

• 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.

What we’re looking for:
Required qualifications:

• Bachelor’s degree in Biomedical Engineering, Computer Engineering, Electrical 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 developing Electromechanical Equipment
• 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 using LabVIEW visual programming language
• Experience using Minitab statistical software
• Experience using MATLAB programming language

Maximum Salary: $ 156900

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. 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.