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Mechanical Manufacturing Engineer
Not specifiedFull-timeMechanical EngineeringMedical Devices
A medical-device manufacturer is seeking a hands-on Mechanical Manufacturing Engineer to lead advanced production processes, engineering changes, and cross-functional projects in a growing technology environment.
Responsibilities
- Lead manufacturing problem-solving and continuous improvement, including failure analysis, root-cause analysis, ECOs, yield improvement, and cost reduction.
- Develop, characterize, validate, and implement stable and efficient manufacturing and assembly processes in accordance with medical quality standards and ISO 13485 requirements.
- Design and develop manufacturing fixtures, jigs, and engineering aids.
- Prepare work, manufacturing, and maintenance instructions, drawings, and material specifications.
- Lead NPI transfers from development to serial production in close collaboration with R&D, quality, and operations teams.
- Coordinate protocols, reports, and IQ/OQ/PQ validation activities for manufacturing equipment and processes with quality assurance.
- Lead cross-functional engineering projects from initiation through execution.
- Work with development, quality, procurement, and operations teams in a dynamic, multi-interface environment.
Requirements
- Bachelor’s degree in Mechanical Engineering is required.
- At least 3 years of experience as a Manufacturing or Production Engineer.
- Demonstrated experience leading engineering changes and ECO processes.
- Experience designing and developing manufacturing fixtures and tools using SolidWorks.
- High-level English proficiency.
- Strong attention to detail combined with systems thinking.
- Independent, hands-on approach and ability to lead processes end to end.
- Creative problem-solving and ability to develop innovative engineering solutions.
- Strong interpersonal and cross-functional collaboration skills.
Nice to have
- Experience transferring products from development to serial production through NPI.
- Experience with ERP or PLM systems for BOM management and configuration control.