Manufacturing Engineer

Mantu; Warsaw (IN); On-site; USD 80,000 - 105,000; Full time

Job summary

Mantu in Warsaw, Indiana, is seeking a Manufacturing Engineer for a fully onsite role. You will drive ECR/ECN activities, BOM updates, and documentation while collaborating with Operations, Quality and Engineering to ensure readiness and regulatory compliance.

The ideal candidate combines hands-on manufacturing engineering experience with strong documentation, change-management skills, and effective cross-functional collaboration, in a regulated medical device environment.

Qualifications

• Bachelor's degree in Biomedical, Mechanical, Manufacturing, Industrial Engineering, or related field.
• 3+ years of manufacturing engineering experience in regulated medical device environments.
• Hands-on Windchill BOM updates, engineering changes, and change management.
• Experience with equipment qualification/validation (OQ and PQ) and Gage R&R knowledge.
• Knowledge of control plans, MES/master data, and regulated change-control processes.
• Strong communication, teamwork, and cross-functional collaboration.

Responsibilities

• Own and review ECRs, ECNs, BOM updates, routers, and work instructions.
• Walk manufacturing processes to assess readiness and support changes.
• Support equipment installation, qualification, validation, and decommissioning.
• Support quality records such as NCRs, IE investigations, and CAPAs.
• Support MES readiness and Windchill change management.
• Collaborate with Operations, Quality and Engineering to improve manufacturing flow.

Skills

Manufacturing experience

Windchill knowledge

Engineering changes

Change management

OQ/PQ concepts

Gage R&R

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Biomedical, Mechanical, Manufacturing, Industrial Engineering, or related field

Tools

Windchill

Vault DMR

MES/master data

Job 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.