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.

Requirements:

• 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.

• 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