Process Engineer 1

Main Responsibilities

• Support design transfer, specifically the final assembly, labeling, packaging, and serialization of products as they hand-off from development to commercial launch.
• Support the design, qualification, and implementation of new production equipment.
• Draft and update Engineering Protocols (ENP) and Reports (ENR), Batch Records (BR), Bill of Materials (BOM), Technical Specifications (TS), Product Specifications (PS), Quality Work Instructions (QWI), Quality Operating Procedures (QOP), Quality Forms (QF), Templates (TEM), equipment design and qualification documentation (e.g., URS), pFMEAs, Change Controls, etc.
• Draft documentation for computerized system validation (CSV) including Functional/Design Specifications, Design Qualification (DQ), Functional Risk Assessment (FRA), Requirements Traceability Matrix (RTM), etc.
• Draft and execute Validation Project Plans (VPP), Validation Final Reports (VFR), and periodic reviews, as well as protocols and reports for Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, Installation Operational Qualification (IOQ), Performance Qualification (PQ), and Process Validation (PV).
• Document MS activities to support the MS Key Performance Indicators (KPI) tracking.
• Perform troubleshooting and root cause analysis with a cross-functional team to conduct investigations, Non-conformance Reports (NCR), Corrective and Preventive Actions (CAPA), etc.
• Serve as the second line of support after Manufacturing Engineering (ME) to Manufacturing (MFG).
• Provide training on production equipment to ME and MFG personnel.
• Identify opportunities for continuous improvement in MS and support the execution and implementation of LEAN projects.
• Support and conduct customer complaint investigations.
• Support or lead machine shop activities.

Skills And Qualification

• B.S. in Biomedical Engineering/Mechanical Engineering or any relevant branch of study is preferred.
• 0-2 years of experience within the medical device industry is preferred.
• Familiarity with industry practices and guidelines including those outlined by the FDA and ISO is required.
• Knowledge of Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) is required.
• Must have practical experience and a solid understanding of mechanical design principles, testing, and manufacturing processes.
• Proficiency in Microsoft Excel and Microsoft Word is required.
• Educational background and experience in the medical device industry is preferred.