Job Description Summary

Job Description

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• Systems Engineers are responsible for design inputs framework creation and conducting design input reviews in projects. They are good at requirement framing and understanding of verification and validation methods for medical devices.
• These individuals are members of a team working with cross functional groups, stakeholders and customers to understand the product needs and perform needs/requirement elicitation.
• They have a good knowledge of medical device product development as per design control procedures such as ISO 13485, FDA 21 CFR 820.30 etc. and apply this knowledge to contribute to various stages of the product development lifecycle stages from concept till launch.
• They work in the ALM tool such as Polarion to create artifacts such as work items, live docs or live reports and release design control documents throughout multiple stages of the product lifecycle.
• They are expected to develop justifications and performance requirements based on engineering 1st principles and should have a solid foundation in mechanical, materials, and fluid dynamics.
• These individuals deploy tools and processes such as Design for Six Sigma and BD’s Global Product Development System to enable more predictable product development and high quality/value products. In addition to technical expertise, system architects bring strong leadership and team building skills.

Education and Experience:

• B.S. or M.S in Mechanical Engineering or Sciences
• Minimum of 3 years relevant experience or a combination of education and experience.

Knowledge and Skills:

a. Knowledge

• Contributes to the completion of specific programs and projects, including design inputs creation and deliverables related to other product development lifecycle stages. Failure to obtain results or erroneous decisions would result in serious program delays.
• Contributes to management of product requirements and high-level design specifications directed by a supervising Systems Architect. Works under general direction.
• Assumes a technical contributor role and works closely with other functional groups. May provide guidance and work direction to lower project level contributors.
• Independently evaluates problems of moderate complexity and applies analytical/scientific principles to fulfill project and business objectives. Performs activities independently within defined parameters with minimal supervision.
• Collects, records, reports, interprets, and analyzes data, presents results to cross functional colleagues and leaders.
• Contributes to the transition from Architecture to Design and to system verification and validation activities.

b. Required Skills

• Excellent written and oral communication and interpersonal skills.
• Demonstrated capability as member of a project team.
• Demonstrated capability with medical device product development and requirement management.

c. Preferred Skills:

• Experience with preparing Power BI dashboards.
• Experience with writing SQL based queries.
• Ability to handle large complex data.
• Experience with relational databases.

Required Skills

Optional Skills

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Primary Work Location

Additional Locations

Work Shift