Job Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. Client has operations in more than 40 countries around the world.
Job Title: Manufacturing Engineer
Location: Warsaw, IN
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Location: Warsaw, IN
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Job Description:
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Position summary
The Manufacturing Engineer supports process readiness, engineering changes, equipment activities, work instruction development, and manufacturing system implementation to ensure efficient and compliant site operations. This role requires strong Windchill knowledge, Equipment qualification/validation knowledge, Gage R&R experience, control plan knowledge, and Vault DMR update knowledge to support documentation accuracy, qualification activities, manufacturing controls, and design/manufacturing change execution.
- The engineer will support manufacturing operations by fulfilling the following responsibilities:
- Prepare and maintain manufacturing transfer documentation.
- Implement and manage engineering changes for BOM and Routers.
- Update and standardize procedures, SOPs, and work instructions as aligned with project requirements and requested per the project plan.
- Communication & Collaboration: Maintain effective communication within the team and with stakeholders; facilitate collaboration across functions.
- Provide project status reporting as per defined cadence and stakeholder requirements, ensuring visibility of progress and risks.
- Change Management: Manage and implement change requests for fixtures, control plans, inspection documents, work instructions, and routing/BOM updates.
- Engineering Review: Ownership of manufacturing-related changes within ECR/ECN processes.
- Perform any other relevant tasks assigned by the client project lead
Key responsibilities
- Support site Quality records such as NCR's, IE's, and CAPA's.
- Own and Review ECRs, ECNs, routers, BOM updates, and work instructions.
- Walk processes to assess readiness, risks, and implementation needs.
- Support equipment installation, qualification, validation, and decommissioning activities.
- Assist with protocol creation, execution support, and report activities tied to manufacturing changes.
- Support MES readiness and manufacturing master data activities.
- Use Windchill to review, manage, and support engineering documentation and change activity.
- Support Info PV equipment qualification activities, including documentation, execution support, and traceability.
- Apply Gage R&R methods to evaluate measurement system capability and support process controls.
- Develop, review, and maintain control plans to ensure manufacturing process consistency and compliance.
- Support Vault DMR updates and maintain accuracy of controlled manufacturing records and related documentation.
- Partner with Operations and Quality to improve flow, efficiency, and manufacturability.
Required qualifications
- Bachelor's degree in Mechanical, Manufacturing, Industrial, or related engineering field.
- Experience in manufacturing engineering in a regulated production setting.
- Strong Windchill knowledge.
- Working knowledge of equipment qualification/validation processes and documentation.
- Experience with Gage R&R studies and interpretation.
- Strong control plan knowledge.
- Experience with Vault DMR updates and controlled document maintenance.
- Experience with process changes, documentation, and cross-functional implementation.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Warsaw, IN |
| Industry | Computer/IT Services |
| Salary | $43.86 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
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