Senior Medical Device Process Engineer

Sanner America (formerly Gilero); Pittsboro (NC); Presencial; USD 85.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Medical plans (BCBS)

Dental & Vision

Life insurance

Parental leave

Disability insurance

401(k) match

LinkedIn Learning

Descripción de la vacante

Sanner America (formerly Gilero) is seeking experienced Process Engineers to support development and manufacturing of assembly automation for medical devices at our Pittsboro, NC plant. The roles involve designing and implementing manufacturing processes, working with cross-functional teams, and ensuring compliance with ISO 13485 and FDA 21 CFR Part 820.

Candidates should have 3+ years in medical device manufacturing, CAD experience, and strong problem-solving skills; join a collaborative team

Formación

• BS in Engineering or equivalent technical degree.
• Minimum 3 years of relevant experience in manufacturing medical devices.
• Knowledge of medical device regulations (FDA/ISO).
• Experience with SolidWorks, Pro/Engineer or other CAD software.
• Experience with Lean/Six Sigma/5S is a plus.

Responsabilidades

• Develop and deliver new manufacturing process capabilities including design of experiments (DOE).
• Evaluate device designs for manufacturability (DFM/DFA).
• Establish process flow and line layouts for efficient, scalable manufacturing cells.
• Write and execute protocols to assess process capability (IQ/OQ/PQ).
• Lead project activities with budgets, resources, and timelines.

Conocimientos

Communication

Project coordination

Problem solving

Educación

Bachelor's degree in Engineering

Herramientas

SolidWorks

Pro/Engineer

3D CAD modeling

Excel

Word

Descripción del empleo

Sanner America (formerly Gilero) is seeking experienced Process Engineers to support development and manufacturing of assembly automation for medical devices at our Pittsboro, NC plant. The roles involve designing and implementing manufacturing processes, working with cross-functional teams, and ensuring compliance with ISO 13485 and FDA 21 CFR Part 820.

Candidates should have 3+ years in medical device manufacturing, CAD experience, and strong problem-solving skills; join a collaborative team