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Senior Engineer, Device Technical Operations (Hybrid)

🕒 5 days ago
Design ControlsRisk ManagementManufacturing SupportProblem Solving

📜 Description

  • Provide support for internal and external component manufacturing globally.
  • Identify issues and provide solutions through problem-solving and root cause analysis.
  • Optimize design and manufacturing processes using engineering best practices.
  • Foster a culture of inclusion by integrating diverse perspectives to meet stakeholder needs.

🛠️ Requirements

  • Bachelor's degree in mechanical engineering, biomedical engineering, or a related technical field required; advanced degree preferred.
  • Minimum of 5 years of experience in pharmaceutical, biologic, medical device, or combination product engineering.
  • Proven expertise in design controls, risk analysis, control strategies, and process validation.
  • Demonstrated technical experience in injection molding, automation, and complex assembly operations.
  • Direct experience in autoinjectors, ophthalmic products, or inhalation products highly preferred.

Benefits

  • Utilize extensive experience in design controls, design transfer, and risk management to develop solutions for medical devices.
  • Build a design engineering mindset for medical devices, ensuring compliance with regulatory standards.
Full job description

The Senior Engineer - Device Technical Operations is a pivotal role focused on enhancing engineering capabilities for medical devices and managing manufacturing processes for complex drug-delivery systems.

Description

  • Provide support for internal and external component manufacturing globally.
  • Identify issues and provide solutions through problem-solving and root cause analysis.
  • Optimize design and manufacturing processes using engineering best practices.
  • Foster a culture of inclusion by integrating diverse perspectives to meet stakeholder needs.

Requirements

  • Bachelor's degree in mechanical engineering, biomedical engineering, or a related technical field required; advanced degree preferred.
  • Minimum of 5 years of experience in pharmaceutical, biologic, medical device, or combination product engineering.
  • Proven expertise in design controls, risk analysis, control strategies, and process validation.
  • Demonstrated technical experience in injection molding, automation, and complex assembly operations.
  • Direct experience in autoinjectors, ophthalmic products, or inhalation products highly preferred.

Benefits

  • Utilize extensive experience in design controls, design transfer, and risk management to develop solutions for medical devices.
  • Build a design engineering mindset for medical devices, ensuring compliance with regulatory standards.
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