Systems Engineer - JR-048141

Pune, India    |     Other   |   Full-time
Job Reference: 6398 - Posted 23-Jan-2024

Job Title: Systems Engineer - Personal Health Care

Location: Pune, India

Experience: 3-8 Years

Qualification: Bachelors or master’s in engineering

Skillsets: Human Factor Engineering, Risk Analysis, Systems Design, Product Design


Job Description:


Roles and Responsibilities:

         Work with internal and external customers/stakeholders and the product development teams, collect, analyze, and translate customer needs into requirements and specifications.

         Apply System Engineering methodologies/tools (use case analysis, functional architecture design, Requirements Management in DOORs) in the product design and development cycle to ensure quality in design.

         Working on preparing the procedure documents, Design Descriptions, System Requirements Documents, Compliance to Standards, V & V documents, and FDA submissions.

         Lead the risk management activities (risk assessment and control, DFMEA, FTA, usability risk analysis, etc.) for the product.

         Understand and apply appropriate Human Factors in systems design and develop use specifications, user interface requirements, etc.) to ensure product is designed in compliant to relevant usability guidelines/standards. Conduct studies and tests to ensure system meets the HF requirements.

Job Requirements:

         Bachelor’s degree or above in science or engineering field.

         3-5 years in medical devices and Mechanical Engineering experience with relevant experience in System Engineering on Personnel health care products

         Trained / experienced in ISO 14971, IEC60601, HE 75, Human Factor Engineering, etc.

         Trained / experienced in ISO 13485 or FDA 21 CFR 820

         Certification in Systems Engineering is preferred.