Manufacturing Engineer

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.

• 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.

• 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.

• 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
  .