Manufacturing Engineer at Mantu Manufacturing Engineer at Mantu in WINONA LAKE, Indiana Posted in 9 days ago.

Type:

full-time

Job Description:

Manufacturing Engineer Mission Description The Manufacturing Engineer supports manufacturing process readiness, engineering changes, equipment qualification activities, controlled documentation, and manufacturing system implementation within a regulated medical device manufacturing environment. The ideal candidate combines hands-on manufacturing engineering experience, strong documentation and change-management skills, and effective communication and collaboration abilities . This is a 100% onsite position , with preference for local candidates; candidates open to relocation will also be considered.

Main Responsibilities Engineering Changes & Documentation:

Own and review ECRs, ECNs, BOM updates, routers, work instructions, and related manufacturing documentation using Windchill , ensuring accurate and timely implementation of engineering and process changes.

Manufacturing Process Readiness:

Walk manufacturing processes to assess readiness, identify risks and gaps, and support the implementation of process and engineering changes in collaboration with Operations, Quality, and Engineering.

Equipment Qualification & Validation:

Support equipment installation, qualification, validation, and decommissioning activities, including protocol preparation, execution support, documentation, and reporting. Apply basic knowledge of OQ and PQ principles and qualification requirements.

Quality & Process Controls:

Support quality records such as NCRs, IE investigations, and CAPAs. Apply basic Gage R&R knowledge to support measurement system evaluation, with additional guidance and training available from the team.

Manufacturing Systems & Controlled Records:

Support MES readiness, manufacturing master data, Windchill change management, and Vault DMR updates , maintaining accurate and compliant manufacturing documentation and records.

Cross-Functional Collaboration & Continuous Improvement:

Partner closely with Operations, Quality, and Engineering to improve manufacturing flow, efficiency, and manufacturability while communicating effectively with stakeholders and supporting successful implementation of changes. Qualifications Bachelor's degree in Biomedical, Mechanical, Manufacturing, Industrial Engineering, or a related engineering field. Recent graduates/new graduates are welcome to be considered if they demonstrate relevant technical knowledge, internships, projects, or co-op experience. Approximately 3+ years of manufacturing engineering experience , ideally within biomedical, medical device, or another regulated manufacturing environment . Strong candidates with less experience may also be considered based on relevant technical background. Hands-on experience with Windchill , particularly BOM updates, engineering changes, and change management within a manufacturing or product development environment. Basic working knowledge of equipment qualification/validation , including OQ and PQ concepts, protocols, execution support, and documentation. Experience with Gage R&R is preferred; foundational knowledge is sufficient, as team training/support will be provided. Knowledge of control plans, manufacturing documentation, Vault DMR updates, MES/master data, and regulated change-control processes . Experience working within a medical device quality system is strongly preferred. Strong soft skills and cross-functional collaboration abilities , including clear communication, teamwork, ownership, problem-solving, attention to detail, adaptability, and the ability to work effectively with Operations, Quality, and Engineering teams. Work Location 100% onsite manufacturing environment. Candidates who are open to relocation will also be considered. The role is particularly well suited for candidates with experience in medical devices/biomedical manufacturing, Windchill BOM and change management, and regulated production environments .