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
- Bachelor’s degree in Biomedical, Chemical or Mechanical Engineering (preferred)
- Master’s degree in the above fields strongly preferred.
- 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
- 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
- International travel up to 20%
We regret to inform you that only shortlisted applicants will be notified. Thank you for your kind understanding.
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