Validation Engineer
1 week ago
- uthor/Develop Risk Assessment, User Requirement Specification, Validation Plan, IQ/OQ/PQ, SOP, FMEA, RTM, and Validation Report.
- Perform IQ/OQ/PQ test execution for manufacturing equipment.
- Experience in Test Method Validation, Gage R&R, Minitab, and Process Validation.
- Hands-on experience in GAMP 5, FDA 21 CFR Part 11, Data Integrity, ALCOA requirements.
- In-depth understanding of FDA regulations (21 CFR Parts 820, 210/211).
- Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to define validation requirements and risk-based testing strategies.
- Investigate and resolve software or system-level issues found during validation or manufacturing use.
- Experience in ATE system validation in the medical device industry.
- Measurement System knowledge.
- Ultrasonic Washer.
- Barcode Scanner.
- Bio-Burden Hood.
- uto Cannula Sorter.
- ir Blockage Tester.
- Lasermike / Bench Top Laser Mike.
- Farrel Mixer Controller and Puller.
- Puller/Cutter.
- Rubber Slicer.
- Extruder W/ Water bath.
- Flow Tester.
- Printex/ Zebra Printers/ Printronix Printer/ Image Pouch Printer.
- Bladder Sorter Auto Machine.
- utomatic Tube Set Assembly Machine.
- Snap Cap Welding Machine.
- Longford Labeler/ Universal Labeling System/ Labeling Machine.
- Herrmann Welder.
- Uson Leak Tester/Two Up Tester/Coiled Fill Port Tester.
- Battery Simulator.
- Battery Module Communication Test Fixture.
- Keypad misuse test fixture.
- Bachelor's or Master's in Biomedical Engineering, Instrumentation Engineering, Electrical Engineering, Measurement Engineering, Mechanical Engineering, or related field.
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ATE Software Validation Engineer
5 days ago
Skaneateles, NY, United States Katalyst Healthcares and Life Sciences Full timeRoles & Responsibilities: Lead software validation efforts for ATE systems used in testing infusion pumps, patient monitors, or diagnostic devices. Develop validation protocols, test plans, scripts, and reports in alignment with FDA 21 CFR Part 820, Part 11, and ISO 13485. Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to define...
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ATE Software Validation Engineer
7 days ago
Skaneateles, NY, United States Katalyst Healthcares and Life Sciences Full timeRoles & Responsibilities: Lead software validation efforts for ATE systems used in testing infusion pumps, patient monitors, or diagnostic devices. Develop validation protocols, test plans, scripts, and reports in alignment with FDA 21 CFR Part 820, Part 11, and ISO 13485. Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to define...
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Manufacturing Engineer
2 weeks ago
Skaneateles, NY, United States Katalyst Healthcares and Life Sciences Full timeJob Description: You are a problem solver. Complex projects or unexpected challenges are opportunities to apply your considerable abilities. Whether working independently or with a trusted team, you are always ready to tackle a project and find solutions. Your talent is needed across a wide variety of industries. As a Manufacturing Engineer, you have a...
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Manufacturing Engineer
2 weeks ago
Skaneateles, NY, United States Katalyst Healthcares and Life Sciences Full timeJob Description: You are a problem solver. Complex projects or unexpected challenges are opportunities to apply your considerable abilities. Whether working independently or with a trusted team, you are always ready to tackle a project and find solutions. Your talent is needed across a wide variety of industries. As a Manufacturing Engineer, you have a...
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Technical Lead
7 days ago
Skaneateles Falls, NY, United States Futran Tech Solutions Pvt. Ltd. Full timeJob Description & Skill Requirement: Project management Work closely with operations and the business functions to ensure quality, performance of products and processes for medical devices Remediation lifecycle. Responsibilities: • Remediate Manufacturing, DHF, DMR Documents of new and legacy products to current organization standards and policies. •...
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Technical Lead
5 days ago
Skaneateles Falls, NY, United States Futran Tech Solutions Pvt. Ltd. Full timeJob Description & Skill Requirement: Project management Work closely with operations and the business functions to ensure quality, performance of products and processes for medical devices Remediation lifecycle. Responsibilities: • Remediate Manufacturing, DHF, DMR Documents of new and legacy products to current organization standards and policies. •...
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Technical Lead
23 hours ago
Skaneateles Falls, NY, United States Futran Tech Solutions Pvt. Ltd. Full timeJob Description & Skill Requirement: Project management Work closely with operations and the business functions to ensure quality, performance of products and processes for medical devices Remediation lifecycle. Responsibilities: • Remediate Manufacturing, DHF, DMR Documents of new and legacy products to current organization standards and policies. •...
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Technical Lead
7 days ago
Skaneateles Falls, NY, United States Futran Tech Solutions Pvt. Ltd. Full timeJob Description & Skill Requirement: Project management Work closely with operations and the business functions to ensure quality, performance of products and processes for medical devices Remediation lifecycle. Responsibilities: • Remediate Manufacturing, DHF, DMR Documents of new and legacy products to current organization standards and policies. •...
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Senior Manufacturing Engineer
1 day ago
Niagara Falls, NY, United States Boyd Company Full timeJob Description: POSITION SUMMARY: The Senior Manufacturing Engineer is responsible for developing and enhancing manufacturing equipment and processes for both new and existing heat transfer products. This role involves a variety of process improvement projects, including general production, aluminum welding processes, and quality enhancement...
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Senior Manufacturing Engineer
1 week ago
Niagara Falls, NY, United States Boyd Company Full timeJob Description: POSITION SUMMARY: The Senior Manufacturing Engineer is responsible for developing and enhancing manufacturing equipment and processes for both new and existing heat transfer products. This role involves a variety of process improvement projects, including general production, aluminum welding processes, and quality enhancement initiatives....