Boston Scientific Engineer II System Evaluation 

India, Maharashtra, Pune 

199570273

India-Haryana, Gurgaon

The job requires a self-motivated individual having more than 8 years of experience in product testing of Class-II and Class-III medical devices software system which includes Web server, mobile application and medical device software. Urology/Implantable Domain knowledge will be preferred.

Key Responsibilities

• Analyze system requirements, user needs and system design, perform system evaluation activities (i.e. validation, verification).
• Transform requirements into comprehensive test protocols and automated test scripts.
• Develop and maintain high quality non-medical device software tools in a regulated environment to support system design and system evaluation activities.
• Documents software development and/or test development by writing documents, reports, memos, change requests. Methods used are determined by approved procedures and standards
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving System level issues.
• Interact with business analysts, SMEs and QA team members.

Qualifications:

• B.E./B.Tech in ECI, Biomedical, preferable.
• 5–8 Years of experience to be considered.
• Manual Tester, Engineer should have automation with Python knowledge.
• Testing experience in medical device (Implant Experience) is required.
• Must have ISO Standard 13485.
• Manual Tester
• Exposure to 62304 is recommended.

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.