| Looking On-site || Medical Device & Regulations, EIS : New Product Introduction Process (NPI) || WARSAW, IN (Onsite) at Warsaw, New York, USA |
| Email: [email protected] |
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From: Gaurav, Quantum World IT [email protected] Reply to: [email protected] Greeting, I hope all is well with you For the following, Quantum World IT is seeking the best consultant profile. Please respond with your most recent resume if you are considering new opportunities. Looking On-site || Medical Device & Regulations, EIS : New Product Introduction Process (NPI) | | WARSAW, IN (Onsite) Role name: | Engineer | Role Description: | Medical devices technical transfer Supporting medical device manufacturing Develop and validate robust manufacturing processes for new product introductions. Collaborate with design engineering teams to ensure designs are manufacturable and cost-efficient. Manage the transition of products from development to production, ensuring readiness of equipment, tooling, and processes. Partner with supply chain teams to qualify and onboard suppliers. Establish and oversee pilot production runs to ensure process capability and stability. Lead the creation of process flow diagrams (PFDs), control plans, and work instructions for new product lines. Process characterization, equipment IQ/OQ, process OQ, and PQ Test method Validation, Gage R&R Creating, maintaining, and improving controlled technical documents such as prints, procedures, bills of materials, and routers. Supporting a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc. Conducting feasibility study to estimate a product cost and analyze capital equipment, capacity, and capability requirements Establishing and improving process methods that meet performance and quality requirements Developing and executing project plans and schedules for work activities Communicate (written and verbal) direction and project plans with appropriate personnel from other departments. Evaluating multiple options to select the most appropriate processes and machining methods | Competencies: | EIS : Medical Device & Regulations, EIS : New Product Introduction Process (NPI) - Product Engineering | Experience (Years): | 10 & Above | Essential Skills: | The Principal Engineer, having 20+ years of experience in Manufacturing and NPI, will serve as the technical authority in manufacturing process development and transfer for new medical device products. This role focuses on ensuring manufacturability, scalability, and efficiency in alignment with quality and regulatory standards. The incumbent will lead cross-functional initiatives to bring innovative products from development to production while driving process excellence and operational readiness. | Desirable Skills: | The Principal Engineer, having 20+ years of experience in Manufacturing and NPI, will serve as the technical authority in manufacturing process development and transfer for new medical device products. This role focuses on ensuring manufacturability, scalability, and efficiency in alignment with quality and regulatory standards. The incumbent will lead cross-functional initiatives to bring innovative products from development to production while driving process excellence and operational readiness. | Country: | United States | Please enter the following information is needed for submission and Photo id Position Applied for | | Candidate Full Name [As per Passport] | | Contact Number Primary & Secondary | | Current Location | | Email | | Work Authorization | | Total years of Experience | | Had ever worked with TCS in Past (Required filed) | | Have you gotten covid Vaccination does | | LinkedIn ID | | Are you comfortable for on-site | | Rate | | Gauarv Kumar Phone: +1 8053915957 Email: [email protected] Quantum World Technologies Inc. 4281 Katella Ave, Suite #102 Los Alamitos CA 90720 USA Keywords: rlang information technology California Idaho Looking On-site || Medical Device & Regulations, EIS : New Product Introduction Process (NPI) || WARSAW, IN (Onsite) [email protected] |
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| 01:30 AM 28-Dec-24 |