Manufacturing Engineer II

Job Description – Manufacturing Engineer IILocation: Dexter, MIDuration: 05/25/2026 – 08/25/2026Schedule: 40 hours/weekWork Type: OnsiteInterview Timeline: ImmediatePosition SummaryWe are seeking a Manufacturing Engineer II to support the Crescent/Nautilus product line in a regulated medical device manufacturing environment. This role will focus on equipment qualification, process validation, manufacturing process improvements, and compliance-driven engineering activities. The ideal candidate will have hands-on experience with IQ/OQ/PQ protocols, process validation lifecycle activities, and medical device manufacturing systems.Key ResponsibilitiesDesign and improve manufacturing processes, production layouts, equipment installations, and material handling systems.Execute and support Equipment Qualification activities including IQ, OQ, and PQ.Lead and support process validation lifecycle activities including process characterization, operational qualification, and performance qualification.Develop and maintain validation documentation, SOPs, and change control records.Support Computer System Validation (CSV) activities for manufacturing and laboratory systems.Troubleshoot manufacturing, packaging, and laboratory equipment issues to improve process efficiency and product quality.Conduct investigations and implement corrective actions related to equipment and process deficiencies.Collaborate with cross-functional teams including Quality, Manufacturing, and Regulatory Affairs.Ensure compliance with medical device regulations and internal quality standards.Utilize DOE methodologies and Minitab for process optimization and statistical analysis.Required QualificationsBachelor’s Degree in Engineering or related technical field.2+ years of relevant manufacturing engineering experience.Experience with Equipment IQ/OQ/PQ activities.Experience with Process Validation in regulated manufacturing environments.Knowledge of process validation lifecycle methodologies.Experience with manufacturing troubleshooting and technical problem-solving.Familiarity with SOP development and change control processes.Understanding of Quality Assurance and Process Control principles.Preferred QualificationsMedical device industry experience.Experience with DOE and Minitab.Computer System Validation (CSV) experience.Experience with equipment commissioning and qualification.Familiarity with packaging and laboratory equipment validation.