Principal Engineer

The Principal Engineer will be solely responsible to manage a group of subject matter experts within a given project, and be the right-hand support (technical lead) for the project manager to deliver on all technical matters in the project.

Key duties and responsibilities:

• Lead a team of subject matter experts (e.g., Optics, Materials, Plastics, Molding, Biocomp)
• Serve as the technical lead for a project manager, and be responsible on the delivery of all technical aspects of a given project
• Understand all aspects of technology without being an SME in order to ensure all SMEs deliver to the quality and timeline of a given project
• Possess the knowledge of all design control procedures for medical device design, development, verification and validation
• Lead risk assessment activities, and be a strong partner with Quality Assurance (QA) and Manufacturing Operations
• Lead projects to discuss and address any technical issues
• Assume role of technical lead for projects through launch and post-launch
• Develop and follow standardized technical documentation
• Oversee high quality technical documentation for regulatory submissions across the globe

Education

• Bachelor’s degree in Biomedical, Chemical or Mechanical Engineering (preferred)
• Master’s degree in the above fields strongly preferred.

Experience

• 5-10 year of experience with design & development of Class IIb or Class III medical devices
• Proven work experience as a senior level process engineer in the medical device industry
• Working knowledge of plastics and molding

Skills

• Thorough knowledge of medical device development
• Strong skill in statistics
• Interpersonal skills in developing positive working relationships with other employees.
• Experience working with SolidWorks and/or CAD preferred

Travel requirements

• International travel up to 20%