IT
Job DescriptionRole: Senior Manufacturing Lead
Location: Temecula, CA
Duration: 6+ Months
BGV will be done for the selected candidates.
1) Manufacturing experience in Medical Devices, especially disposable Cardio-Vascular products.
2) Six Sigma certified (Black Belt)
3) Experience in CTQs assessment and translating CTQ into manufacturing specifications
4) Experience in performing gap assessments between design outputs and manufacturing specifications
5) Design and develop manufacturing processes, tooling, and fixtures in order to meet production needs, while enhancing productivity and product quality
6) Process Validation – Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ)
7) Experience in performing process characterization studies / Design of Experiments (DOE) to establish the process window / range for all the influencing process parameters
8) Experience in Test Method Validation (TMV) & Inspection Method Validation (IMV)
9) Utilization of tools like Gage R&R, Cp, Cpk, and Statistical Process Control (SPC) to improve manufacturing processes
10) Good experience in Lean manufacturing. Understanding of manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.
11) Experience in Manufacturing process improvements / Manufacturing yield improvements to improve product quality
12) Good knowledge in Statistics & Minitab
13) Experience in Product Risk Management as per ISO14971 with good knowledge in executing PFMEA
14) Experience in handling CAPA (including field failure / root cause investigation), SCAR and NCMRs
Six Sigma (Green belt), Medical Device, Manufacturing, Cardio-vascular, catheter, Process validation, Test Method validation, GD&T, Tolerance analysis, Jigs & Fixture design, Statistics, Minitab, Poka-Yoke, Process development, Process improvement, Value Stream mapping
Mandatory Skills
Technical / Soft Skills
Expertise Level (Expert / Good / Knowledge)
Remarks
Poka-Yoke
Expert
-
Process improvement
Good
-
GD&T
Good
-
Tolerance analysis
Good
-
Test Method validation
Good
-
Process validation
Good
-
Cardio-vascular catheter manufacturing process
Good
Desired Skills
Technical / Soft Skills
Expertise Level (Expert / Good / Knowledge)
Remarks
Process development
Good
-
Value Stream mapping
Good
-
PFMEA
Good
-
Please respond with your word resume and requested details:
Full Name :
Work Authorization:
Contact Number :
Email ID :
Skype ID:
Current location:
Willing to relocate :
Rate/hr :
All your information will be kept confidential according to EEO guidelines.
Skills Required
- Manufacturing experience in Medical Devices, especially disposable Cardio-Vascular products.
- Six Sigma certified (Black Belt)
- Experience in CTQs assessment and translating CTQ into manufacturing specifications
- Experience in performing gap assessments between design outputs and manufacturing specifications
- Design and develop manufacturing processes, tooling, and fixtures
- Process Validation including IQ, OQ & PQ
- Experience in performing process characterization studies / Design of Experiments (DOE)
- Experience in Test Method Validation (TMV) & Inspection Method Validation (IMV)
- Utilization of Gage R&R, Cp, Cpk, and Statistical Process Control (SPC)
- Good experience in Lean manufacturing including concepts like Value Stream mapping, 5S and Visual Workplace
- Experience in Manufacturing process improvements / Manufacturing yield improvements
- Knowledge in Statistics & Minitab
- Experience in Product Risk Management as per ISO14971 with good knowledge in executing PFMEA
- Experience in handling CAPA, SCAR and NCMRs
What We Do
Infoways specializes in providing comprehensive consulting, implementation, migration, upgrade, solution development, customizations, functional testing, user training, interface development, and support services for Infor solutions. Our expertise extends to Extensibility, ION, and Report Designer, enabling us to tailor solutions precisely to your requirements. We pride ourselves on our client-centric approach, ensuring that your needs are at the forefront of everything we do. Our services include functional and technical support, admin support, system availability management, incident support, trend analysis, and ticket reduction, among others, all aimed at enhancing your experience and maximizing the value of your Infor investments. Furthermore, our software development capability is at the forefront of innovation. For instance, we are currently enhancing applications in the Financial Services sector using Blockchain technology, showcasing our commitment to leveraging the latest technologies to drive meaningful change for our clients. Infoways offers flexible engagement models and has cultivated a robust talent pool of global resources with expertise in various technologies, including BaaN/LN, M3, Lawson S3, and more. Our team is well-versed in Agile methodology and SDLC best practices, ensuring that projects are delivered on time and within budget. If you are interested in knowing more about how Infoways can support your business and enhance your Infor experience, please let us know. We would be delighted to schedule a meeting with our team at your convenience to discuss Let's Connect We believe in the power of collaboration. Whether you're a client, partner, or future team member, let's embark on this journey together. 📧 [email protected] ☎ 609-718-0720 Join us at Infoways as we navigate the digital landscape, create meaningful solutions, and build a future where innovation knows no bounds.
