Manufacturing Engineer II

Job Title: Manufacturing Engineer II Job ID: 24120 Location: 2500 Silveus Crossing, Warsaw, IN 46582 (Onsite) Duration: 24 Months Pay Rate: $50–$55/hr on W2 Schedule: 40 hours/week Interview Timeline: ASAPRequired Technical Skills (Top 3)Experience with ERP systems (SAP preferred)Experience with EU MDR regulationsExperience with Change Control within Medical Device Quality SystemsEducationBachelor's Degree in Engineering with 2+ years of manufacturing process support experience, ORMaster's Degree in Engineering with 0–2 years of manufacturing environment experienceKey ResponsibilitiesProvide shop floor manufacturing support for machining, metal finishing, and assembly operations.Maintain and update Manufacturing Process Planning documentation and labor standards.Execute change control activities and CAPA processes within the Medical Device Quality System.Support Lean Sigma and continuous improvement projects to improve product quality and reduce manufacturing costs.Assist purchasing teams and suppliers by interpreting product drawings and resolving technical production issues.Support process validation and qualification studies with cross-functional teams.Investigate and manage engineering change requests, including approval, implementation, and documentation.Maintain manufacturing process sheets and update processes based on engineering drawing changes.Coordinate master data management in ERP systems (BOMs, routings, work centers, production versions, material masters, etc.).Ensure compliance with ISO 13485, ISO 14971, MDD 93/42/EEC, 21 CFR Part 820, and other regulatory requirements.Additional SkillsStrong communication and interpersonal skillsAbility to work in fast-paced manufacturing environmentsTeam collaboration and continuous improvement mindsetExperienceMinimum 2 years of experience providing direct manufacturing process support