Project Engineer, Product Transfer

Stryker; Gurugram District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Stryker is seeking a qualified professional to own and drive Supplier Initiated Change Requests (SICRs) in a manufacturing setting. You will manage SICR data in OnePLM, ensure completeness, and coordinate with Global Suppliers to obtain required deliverables for change approvals.

You will lead cross-functional SCRBs, review supplier deliverables, and coordinate with internal teams to ensure changes are executed smoothly, including ECR/ECN activities and promotions within OnePLM.

Qualifications

• Honors Bachelor's degree in Engineering or Science fields or equivalency.
• 3+ years of experience in manufacturing environment or equivalent.
• Basic knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
• Good communication skills.
• Willing to travel in support of business needs to different geographical locations.
• Good knowledge of continuous improvement methodologies
• Hands on experience of PPAP ,MSA, SPC documentation creation, review and Approval from suppliers.
• Good Hands on experience of Validation activity - IQ,OQ & PQ
• Good Know how of Manufacturing processes like welding, Molding, Machining etc.
• Good Hands on experience of PFMEA & Control Plan

Responsibilities

• Support the implementation of process improvements to Corporate/Site/Division Supplier Initiated Change Request procedures and process.
• Serve as owner, execute, and maintain the electronic systems related to SICRs, and support data alignment (SICR Database & OnePLM SICR Library)
• Challenge suppliers SICRs forms for completeness and accuracy. Discuss corrections to the form to guarantee a smooth assignment and execution of the change.
• Own & Execute Supplier Initiated change request (SICR) submitted by Global Suppliers
• Review Submitted SICRs and challenge suppliers for missing information & required deliverables for approving the change
• Organize SCRB with Key Stakeholders and get Buy in for Type of change.
• Review and Approve deliverables submitted by suppliers and coordinate with supplier for any corrections.
• Execute ECR/ECNs and Promotion requests in OnePLM for Change Approval at Stryker end.
• Support communication tools to internal and external customers (suppliers/site/division)

Skills

Communication

SICR ownership

PPAP/MSA/SPC

IQ/OQ/PQ

PFMEA/Control Plan

Manufacturing processes

GMP/ISO knowledge

Travel ready

Education

Honors Bachelor's degree in Engineering or Science

Tools

OnePLM SICR Library

Job description

What you will do:

• Support the implementation of process improvements to Corporate/Site/Division Supplier Initiated Change Request procedures and process.
• Served as owner, execute, and maintain the electronic systems related to SICRs, and support data alignment (SICR Database & OnePLM SICR Library)
• Challenge suppliers SICRs forms for completeness and accuracy. Discuss corrections to the form to guarantee a smooth assignment and execution of the change.
• Own & Execute Supplier Initiated change request (SICR) submitted by Global Suppliers
• Review Submitted SICRs and challenge suppliers for missing information & required deliverables for approving the change
• Organize SCRB with Key Stakeholders and get Buy in for Type of change.
• Review and Approve deliverables submitted by suppliers and coordinate with supplier for any corrections.
• Execute ECR/ECNs and Promotion requests in OnePLM for Change Approval at Stryker end.
• Support communication tools to internal and external customers (suppliers/site/division)

What you will need:

Required qualification:

• Honors Bachelor's degree in Engineering or Science fields or equivalency.
• 3+ years of experience in manufacturing environment or equivalent.
• Basic knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
• Good communication skills.
• Willing to travel in support of business needs to different geographical locations.
• Good knowledge of continuous improvement methodologies
• Hands on experience of PPAP ,MSA, SPC documentation creation, review and Approval from suppliers.
• Good Hands on experience of Validation activity - IQ,OQ & PQ
• Good Know how of Manufacturing processes like welding, Molding, Machining etc.
• Good Hands on experience of PFMEA & Control Plan

Preferred qualification:

• Must enjoy working in a team environment
• Must demonstrate good collaboration and communication skills.
• Highly motivated and able to build relationships internally and externally.
• Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time.
• The individual should enjoy working in a dynamic and results-oriented team environment focusing on quality, compliance and customer satisfaction

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.