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 II
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, process and product transfers, engineering changes, equipment activities, validation execution, work instruction development, and manufacturing system implementation to ensure efficient and compliant site operations. This role requires a minimum of 3 5 years of manufacturing engineering experience in a regulated production environment, with required hands-on proficiency in Windchill and the InfoPV system, along with process transfer experience, equipment qualification/validation knowledge (IQ/OQ/PQ), cleaning, Biological upgrade and packaging validation knowledge, equipment upgrade/change control experience, Gage R&R experience, control plan knowledge, and Vault DMR update knowledge.
Key responsibilities
- Own and review ECRs, ECNs, routers, BOM updates, and work instructions.
- Walk processes to assess readiness, risks, and implementation needs.
- Support equipment installation, qualification (IQ/OQ/PQ), requalification, validation, relocation, and decommissioning activities.
- Support cleaning validation and cleaning process development, including residue and cleanliness acceptance criteria, sampling and test method selection, cleaning agent evaluation, worst-case/bracketing rationale, and periodic revalidation.
- Support packaging validation activities, including package integrity, seal strength and seal process validation, sterile barrier system qualification, distribution/transit simulation, shelf-life and aging studies, and labeling verification.
- Assist with protocol creation, execution support, deviation resolution, and report activities tied to transfers, validations, and manufacturing changes.
- Use Windchill to author, review, manage, and support engineering documentation and change activity.
- Own and execute InfoPV equipment qualification and validation activities, including protocol setup, documentation, execution support, record management, and traceability within the system.
- Develop, review, and maintain control plans, process flow diagrams, and pFMEAs to ensure manufacturing process consistency and compliance.
- Partner with Operations and Quality to improve flow, efficiency, and manufacturability.
Required qualifications
- Bachelor's degree in Mechanical, Biomedical ,Manufacturing, Industrial, or related engineering field.
- Minimum 3 5 years of manufacturing engineering experience in a regulated production setting.
- Required: demonstrated working knowledge of the InfoPV system, including equipment qualification documentation, execution, and traceability within the system.
- Required: strong hands-on Windchill knowledge, including engineering documentation and change management (ECR/ECN, BOM, routers).
- Working knowledge of equipment qualification/validation processes and documentation (IQ/OQ/PQ, requalification).
- Experience with cleaning validation principles, acceptance criteria, and supporting documentation.
- Experience with packaging validation, including seal process validation, package integrity testing, and distribution/aging studies.
- 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 | $50 |
| 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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