Manufacturing Engineer II: Medical Device NPI & Process

Lupin Ltd; Florida; Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Lupin Ltd in Florida seeks an experienced mechanical engineer to support New Product Introduction and Sustaining Activities in a medical device setting. You will engage cross-functional teams and manage stakeholders to drive design transfer and process improvements.

The role involves collaborating with Quality to implement manufacturing controls, maintaining engineering documents, and supporting equipment qualification and process development activities.

Formación

• BS or MS in Mechanical Engineering or equivalent.
• 3 years of experience minimum.
• Experience in medical device industry and pharmaceutical development is highly desirable.
• Lean Manufacturing and Six-Sigma expertise preferred.
• Knowledge of regulatory, QA, cGMP and ISO/ICH standards is beneficial.

Responsabilidades

• Contribute to design transfer and continuous improvement with cross-functional teams.
• Collaborate with Quality to establish manufacturing process controls and quality controls.
• Create and maintain manufacturing documents (engineering drawings, BOMs, Travelers, process instructions, ECOs).
• Coordinate engineering and production builds and draft process instructions.
• Communicate capabilities, schedules and information to facilitate production processes.
• Perform process development activities including IQ/OQ/PQ and calibration requirements.

Conocimientos

Cross-functional collaboration

Stakeholder management

Manufacturing process control

DFx (design for manufacturing)

Root cause analysis

Quality systems

Communication with diverse teams

Educación

BS or MS in Mechanical Engineering

Herramientas

SolidWorks

Descripción del empleo

Lupin Ltd in Florida seeks an experienced mechanical engineer to support New Product Introduction and Sustaining Activities in a medical device setting. You will engage cross-functional teams and manage stakeholders to drive design transfer and process improvements.

The role involves collaborating with Quality to implement manufacturing controls, maintaining engineering documents, and supporting equipment qualification and process development activities.