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New product developer

RA Consultant
Chennai, Tamil Nadu, India
October 27, 2020


Job Description:

The candidate will create, execute, and teach advanced design quality practices. The candidate will be

responsible for supporting Business Development & Engineering/R&D via meetings with prospective

customers and developing a technical relationship with other engineers. The candidate will report to the

VP of Quality and must be able to function with little supervision.

Roles and Responsibilities Include:

- Functioning as a subject matter expert for:

o Quality Engineering – Quality by Design (i.e. proactive risk mitigation through HFE


o Design Assurance – Working with NPD Engineers to control product development

through a phase-gate approach.

o Supplier Qualification – Working with NPD team to research and qualify new suppliers.

o Risk Management – Leading NPD team(s) in creation of dFMEA, pFMEA, and RMR

compliant with ISO-14971.

- Maintaining and improving the Quality Management System.

- CAPA ownership and/or support.

- Interacting effectively with customers, suppliers, and internal resources.

- Managing projects and/or providing project support from the Quality function.

- Facilitating the identification of project risks, developing mitigation actions, and managing

mitigation plan(s).

- Performing root cause analysis and corrective actions.

- Effectively employing problem solving tools/methodology

- Other responsibilities as assigned.


- A Bachelor’s degree in related engineering or technical field (e.g. Mechanical, Chemical, Material

Science, Plastics, etc.) (Required).

- A minimum of 3+ years related work experience in the medical device field (Required).

- A working understanding of ISO-13485, ISO-14971, ISO-9001, ISO-17025, GLP, and 21 CFR 820


- The ability to perform statistical analysis using k-factors, PpK, or capability indices as well as

sample plan creation and analysis (Required).

- Six Sigma Green/Black Belt (Preferred).

- Experience working through all aspects of medical device design/development including


o Design verification & validation.

o Process validation.

o Technology transfer.

- An understanding of design for manufacturability and assembly / design for six sigma

(DFMA/DFSS) (Required).

- Experience with test method development & validation (e.g. measurement/test system

development, gage R&R, etc.) (Required).

- Experience and understanding of design for plastics injection and the mold fabrication processes


- Experience and understanding of the design for profile extrusion processes.

- An understanding of design of experiments (Required).

- Experience and understanding of lean manufacturing (Required).

contact zara : 9176304295