Sr. R&D Engineer

Client:
Medical Device Manufacturing Domain

Duration: 6 Months (It Can be Extend)

Job Responsibilities:

• Design:
  Translates intangible design inputs into tangible engineering specifications and drawings. Makes and presents engineering decisions.
• 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.
• Documentation: write and review product transfer plans, transfer reviews, technical documents/drawings and reports. Prepares and approves verification and validation protocols and reports.
• 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 evaluations, and development unit testing. Plan, develop, execute and manage verification and validation activities for transferring products and processes.
• Fiscal:
  Manages a project budget (expense and/or capital expenditure). Create and critique engineering cost analysis.
• Support Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.
• Support/lead design and process root cause analysis investigations.

Required Qualifications:

• Engineering degree with 4+ yrs of relevant experience.
• Demonstrated hands-on technical aptitude.
• Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to execute validation.
• Ability to create and execute project plans.
• Basic tooling, design and drafting knowledge.
  
  Excellent oral and written communication skills.
• Ability to analyze data, interpret results, and write reports. Proficient in statistic software.