Job Description

1. Provide support to engineering from concept through manufacturing launch for new or revised projects.


2. Work with design, tooling, manufacturing, production and quality departments during the entire development cycle.


3. Review, critique and recommend changes to engineering drawings, specifications, procedures, equipment's etc.


4. Effectively communicates relevant project information to superiors.


5. Interacts with customers & supplier on project related activities with minimal supervision from superiors.


6. Ensures Engineering/Project documents are complete, current, and stored appropriately.


7. Perform research, design, development and testing of products/systems/manufacturing processes as needed for the project.


8. Develop, document and implement FMEA, BOM, SOP's, instructions, layout, flowchart, records and adherence to standards.


9. Recommend and implement product/process improvements and corrective actions.


10. Ability to review Quality inspection reports like FAIR, CpK reports and recommend suggestions to project manager.


11. Research, audit and qualify outside suppliers.


12. Prepare, review and update the SOPs as per SMC quality management systems.


13. Organize, prioritize and manage multiple tasks/projects.


14. This position requires all above duties to be carried out with minimal supervision from superiors and with some amount of self decision making skills.

Other Position Duties:

• Participate in regular meetings with team and provide periodical reports.
• Create MS Project timelines and send weekly updates to project team/manager/customer.
• Make presentation about customer's & suppliers' profile.
• Make project related presentation to existing and prospective customers.
• Participate and support in internal audit program.

Technical/Functional Skill Sets:

• Hands on experience in injection molding process (scientific molding concepts), troubleshooting, injection molds, product/part design, engineering drawings and processes are a must.
• Must have an experience related to medical device validation like IQ, OQ, PQ , PPAP,...etc.
• Working knowledge of the cGMP, ISO 13485:2003, ISO 9001:2008 standards.
• Computer skills to include knowledge of computer software applications like MS Office, Acrobat, CAD, Solid works or related design software, MS Project etc.



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