Manufacturing Engineer
Manufacturing Engineer
Posted on :
24-06-2025
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1 Vacancy
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Job Description
Responsibilities:
- Support day-to-day medical device manufacturing operations ensuring compliance with FDA QSR and ISO 13485 standards.
- Lead and execute equipment qualifications (IQ/OQ) and process validations (OQ/PQ) including cleaning and upgrade validations.
- Perform process characterization and develop test methods including Test Method Validation (TMV) and Gage R&R studies.
- Drive root cause analysis and CAPA investigations for technical/process issues.
- Create and maintain controlled technical documents such as BOMs routers prints and work instructions.
- Support a variety of manufacturing processes including machining casting forging molding finishing cleaning bonding and heat treatment.
- Evaluate manufacturing feasibility studies including capital equipment capacity planning and cost analysis.
- Collaborate cross-functionally to define and implement process improvement initiatives.
- Develop and manage project plans and timelines using Microsoft Project.
- Conduct PFMEA SPC and Critical-to-Quality (CTQ) analyses to ensure process robustness.
- Interface with Change Management systems and handle Nonconformance Reports (NCRs) Engineering Specifications and CAPA documentation.
- 4 6 years of experience in medical device manufacturing support.
- Strong understanding of GMP design control and regulatory requirements (FDA QSR ISO 13485).
- Demonstrated knowledge of BOM & Router creation engineering drawing interpretation and statistical tools.
- Proficiency with tools such as PFMEA SPC Gage R&R and Test Method Validation.
- Experienced in using Microsoft Office Suite Excel-based data analysis and MS Project.
- Familiarity with change control systems NCRs and CAPA processes.
- Working knowledge of CNC programming terminology and tooling design concepts is preferred.
- Strong written and verbal communication skills and ability to work collaboratively in a cross-functional team.
Employment Type
Full Time
Key Skills
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