R&D Engineer III

Job Description Summary

Position Summary :

This position works cross-functionally to lead research and development sustaining projects of complex medical devices. The position implements existing products with to comply with ISO 80369-7 EU MDR requirements, focusing on project planning, innovative medical device design, prototype development, testing characterization, analysis and reporting.

Job Description

Essential / Key Job Responsibilities (including supervisory and / or fiscal) :

• Design development and implementation. : Designs, develops and implements existing products and processes of a medical device, translating ISO standards into tangible engineering specifications and drawings. ISO 80369-7 : 2021 is the primary ISO standard that will be implemented. Makes and presents engineering decisions. Participates and leads cross-functional teams in the implementation of ISO standards applicable to medical device.
• Process Development : develops new processes by understanding key process inputs and outputs, using statistic methods such as DOE as appropriate. Develops new process equipment and tooling, including specification development, vendor selection and negotiation.
• Documentation : write and review product development plans, design reviews, technical documents and reports. Prepares and approves verification and validation protocols and reports. Develops and implements procedures.
• Test Method Development : develop new engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians; prepare and assist in the validation of test methods.
• Testing : conduct engineering and competitor evaluations, and development unit testing. Plan, develop, execute and manage verification and validation activities for products and processes.
• Fiscal : Creates, controls, manages a project budget (expense and / or capital expenditure). Create and critique engineering cost analysis.

Other Responsibilities May Include, However Are Not Limited To

Required Qualifications

Preferred Qualifications

Education And / or Experience

Physical Demands

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. On occasion the employee may work in a preclinical setting like an animal lab, cadaver lab or attend clinical case observations.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

Required Skills

Optional Skills

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift

Skills Required

Testing, Process Development, Documentation