Manufacturing Engineer II - Medical Device Validation

Manufacturing Engineer II - Medical Device Validation at Dexian Manufacturing Engineer II - Medical Device Validation at Dexian in Griffith, Indiana Posted in about 24 hours ago.

Type:

full-time

Job Description:

Job Title :

Manufacturing Engineer II -

Medical Device Validation Location :

Highland , IN Pay range : $40 - $43

Duration :

12+ MONTHS Job Description We are seeking a motivated Manufacturing Engineer II to support manufacturing operations within a fast-paced, FDA-regulated medical device environment. This role is responsible for supporting manufacturing process improvements, validation activities, production support, and continuous improvement initiatives to ensure operational efficiency, product quality, and compliance with engineering and regulatory standards. The ideal candidate will have experience in manufacturing engineering, process support, validation, and troubleshooting within regulated manufacturing environments. Candidates with medical device manufacturing and

IQ/OQ/PQ

validation experience are strongly preferred. Key Responsibilities Manufacturing & Process Support Support daily manufacturing operations and production line performance improvements. Monitor and improve OEE metrics including uptime, quality, performance, scrap reduction, and material usage variance (MUV). Serve as a technical resource for manufacturing production lines and process troubleshooting. Support implementation of continuous improvement initiatives for manufacturing processes and products. Conduct root cause investigations and recommend corrective actions and technical solutions. Validation & Quality Support Support process and equipment validation activities including

IQ/OQ/PQ

protocols and execution. Assist with CAPA investigations, corrective actions, and documentation deliverables. Collaborate with Quality Engineering teams on qualification and process validation activities. Ensure compliance with engineering documentation practices and FDA-regulated manufacturing standards. Engineering & Project Support Support engineering projects and ensure milestones are completed on time and within budget. Develop and update manufacturing documentation, work instructions, and technical reports. Assist with process characterization, tooling improvements, and manufacturing optimization projects. Support training activities related to manufacturing procedures, equipment usage, and documentation practices. Data Analysis & Continuous Improvement Perform technical analysis and problem-solving activities to support production and process reliability. Utilize engineering methodologies such as Six Sigma, DOE, Process Capability, and Gage R&R. Participate in process optimization, automation, and manufacturing efficiency initiatives. Contribute to long-term engineering projects and operational improvement strategies. Qualifications Bachelor's degree in engineering, Technology, or related STEM discipline required. 2-4+ years of manufacturing engineering experience preferred. Experience in regulated manufacturing environments strongly preferred. Validation experience (IQ/OQ/PQ) highly preferred. Knowledge of FDA QSR regulations and medical device manufacturing is a plus. Experience with process improvement, CAPA, root cause analysis, and technical documentation. Familiarity with automation, plastic injection molding, assembly processes, fixturing, and testing techniques preferred. Working knowledge of Six Sigma methodologies and engineering analysis tools. Experience with SolidWorks and mechanical/tooling concepts preferred. Strong communication, organizational, and problem-solving skills. Must be able to work onsite and support facility transition activities as needed. Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions.

Visit https:

//dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.