Biomedical Engineer

Position Summary

This position will serve the role of Engineering Contingent for device development of company products including continuous product improvement within the Development function of company. The candidate will support technical design and development activities for device and combination products and assist the technology transfer.

• Manage medical device test method and specification development, including test method development, validation, transfer, and life cycle management.
• Support the laboratory operation such as sample inventory, equipment qualification and maintenance.
• Conduct characterization for device function, assembly, manufacturability, etc. using both CAE and traditional engineering techniques.
• Test mechanical or electromechanical systems on bench top models or production representative units, during design development and verification.
• Liaise with third parties such as specialist manufacturers and toolmakers.
• Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
• Comply with the Company’s quality assurance requirements as well as applicable regulatory requirements.

• Experience in design control activities.
• Knowledge of primary containers and drug delivery.
• Understanding of mold, fixture design and build as well as application of validation processes (IQ/OQ/PQ).
• Interface with the medical device vendor and tooling company.
• Knowledge of the regulatory and compliance requirements of device design controls and combination products (i.e. FDA QSR 21 CFR Part 4 and 820/ISO
  13485 quality system requirements).
• The duties of this role are generally conducted in a lab environment.
• As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15-30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others;
  
  maintain general availability during standard business hours.

• Bachelor’s degree in Engineering (Biomedical, Chemical, Mechanical, or Electrical Engineering) plus 1 to 3 year experience in laboratory. Experience with injector based combination product preferred.