Project Engineer Product Transfer

Stryker Corporation; Hinoba-an; Hybrid; Confidential; Full time

Job summary

Stryker Corporation is seeking a qualified professional to support the SICR process, implement improvements, and maintain the electronic systems in OnePLM. The role requires collaboration with global suppliers and cross-functional teams to ensure timely change execution.

The candidate should have a strong background in manufacturing, GMP/ISO standards, and experience with PPAP, MSA, and PFMEA. Travel up to 10% may be required.

Qualifications

• Honors Bachelor's degree in Engineering or Science.
• 3+ years of experience in manufacturing environment or equivalent.
• Knowledge of GMP, ISO 13485, 21 CFR Part 820.
• Strong communication skills.
• Willing to travel to different locations.
• Experience with PPAP, MSA, SPC documentation.
• IQ/OQ/PQ validations.
• Understanding of welding, molding, machining processes.
• Experience with PFMEA & Control Plan.

Responsibilities

• Support SICR process improvements and maintain electronic systems.
• Own and execute Supplier Initiated Change Requests (SICRs) and coordinate with Global Suppliers.
• Review SICRs for completeness; challenge suppliers for missing information.
• Organize SCRB with stakeholders and secure buy-in for changes.
• Execute ECR/ECNs and promotions in OnePLM.
• Monitor SICR KPIs and support global SICR initiatives.

Skills

GMP knowledge

ISO 13485 knowledge

21 CFR Part 820 knowledge

Continuous improvement

PPAP

MSA

SPC documentation

IQ/OQ/PQ validation

PFMEA & Control Plan

Manufacturing processes (welding, MOLD

Education

Honors Bachelor's degree in Engineering or Science

Tools

OnePLM

Job description

Work Flexibility: Hybrid

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) Monitor and Maintain SICR KPIs. Support Global SICR Initiatives

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 Travel Percentage: 10% Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote - Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based - You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite - Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid - You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.