Senior Process Development Engineer - Medical Devices

LifeLens Technologies, LLC.; Ivyland (PA); Presencial; USD 120 000 - 180 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health Insurance

Dental & Vision Insurance

Paid Time Off

401(k)

Stock option incentive plan

FSA & dependent care

Resumo da oferta

LifeLens Technologies, Inc. in Ivyland, PA, seeks a Senior Process Development Engineer to lead validation, risk analysis, and process optimization for wearable medical devices.

You will guide engineers, improve production lines, and drive development from research to production while ensuring design for manufacturability. The role requires hands-on leadership, experience with ISO9001/13485, and strong problem-solving; on-site work with a team focused on innovative health monitoring devices.

Qualificações

• Advanced degree in Polymer Science, Chemistry, Chemical Engineering or a related technical discipline is preferred.
• Medical device manufacturing experience is required.

Responsabilidades

• Lead process validation activities including IQ/OQ/PQ protocols and reports, with acceptance criteria.
• Lead and document process risk analyses with statistical sampling plans.
• Establish stable, capable processes meeting manufacturing and quality goals.
• Implement process development discipline and best practices.
• Explore and develop novel processes as designs evolve.
• Support daily manufacturing through process engineering and continuous improvement.
• Evaluate process changes and material interactions.
• Conduct process DOE studies and document reports.
• Implement safety protocols for manufacturing equipment.
• Collaborate with Quality and R&D in process development.
• Other tasks as assigned

Conhecimentos

Process development

DOE

Statistical analysis

IQ/OQ/PQ validation

Polymer materials

Leadership

Manufacturing experience

Microsoft Office

ISO9001/ISO13485

Formação académica

Advanced degree in Polymer Science, Chemistry, Chemical Engineering or related field

Ferramentas

Minitab

Excel

PowerPoint

Word

Descrição da oferta de emprego

LifeLens Technologies, Inc. in Ivyland, PA, seeks a Senior Process Development Engineer to lead validation, risk analysis, and process optimization for wearable medical devices.

You will guide engineers, improve production lines, and drive development from research to production while ensuring design for manufacturability. The role requires hands-on leadership, experience with ISO9001/13485, and strong problem-solving; on-site work with a team focused on innovative health monitoring devices.