Senior Engineer II, Device and Combination Products - Remote

Overview

The Medical Device and Combination Products DPDT Engineer (Sr Engineer 2 Level 8) is responsible for development of medical device components of drug-device combination products, managing design control, risk management, and human factor engineering.

In Short

• Create and own technical documentation.
• Acquire laboratory equipment and instruments.
• Manage device development and regulatory activities.
• Provide product support for commercial products.
• Own complaints process for device products.
• Support regulatory filings and new market indications.
• Manage design control for class II/III medical devices.
• Interface with stakeholders and vendors.
• Create design control documentation.
• Lead risk analyses associated with devices.

Requirements

• University degree in Engineering or related scientific discipline preferred.
• 8-10 years related experience in medical device development.
• Experience managing cross-functional programs.
• Experience leading human factor engineering studies.
• Excellent written and verbal communication skills.
• Comfortable with leading without authority.

Benefits

• Opportunity to work in a cutting-edge biotechnology company.
• Engagement in innovative science and drug discovery.
• Collaboration with cross-functional teams.
• Potential for career growth and development.
• Work in a hybrid environment.