Manufacturing Engineer / Process SME / Receiving-Site Manufacturing Engineer

Function: Manufacturing Engineering
Department / Reports to / Location: To be assigned

Role purpose

Provide manufacturing engineering leadership for the receiving site during process or product transfer. Translate approved product and process requirements into a manufacturable, controlled process and support readiness through implementation.

Key responsibilities

• Assess process documentation, equipment, tooling, materials, capacity, operator skills, and facility needs against receiving-site requirements.
• Develop or update process flow, work instructions, manufacturing layouts, equipment specifications, and related technical records under change control.
• Coordinate equipment installation or modification, trial builds, process development, issue resolution, and production-readiness activities.
• Partner with Quality and Validation colleagues to define the evidence needed to support process qualification and other required verification activities.
• Monitor early production performance, investigate process issues, and implement approved corrective or improvement actions.

Baseline qualifications

• Engineering degree required.
• 2-5 years of medical device experience required.
• Experience supporting production processes, equipment, process documentation, and cross-functional problem solving.
• Ability to interpret technical requirements, analyze process data, and communicate recommendations clearly.

Preferred experience

Experience with regulated manufacturing, site transfer, process qualification, or continuous improvement.