Engineer I, Device Development (Laboratory) - eTeam Inc.
New Haven, CT 06510
About the Job
Title: Engineer I, Device Development (Laboratory)
Location: 100 College Street, New Haven, CT - 06510
Duration: 12 Months Contract
Pay Rate: $42.85/hr on w2
****REQURIED ONSITE 5 DAYS PER WEEK - NEW HAVEN. PARKING WILL BE REIMBURSED****
This is what you will do:
This position will serve the role of Engineer I for device development of client products including continuous product improvement within the Development function of client.
The candidate will support technical design and development activities for device and combination products and assist the technology transfer.
You will be responsible for:
"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.
"Consult 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.
You will need to have:
"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/ISO13485 quality system requirements).
"The duties of this role are conducted in a lab environment.
We would prefer for you to have:
"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.
Location: 100 College Street, New Haven, CT - 06510
Duration: 12 Months Contract
Pay Rate: $42.85/hr on w2
****REQURIED ONSITE 5 DAYS PER WEEK - NEW HAVEN. PARKING WILL BE REIMBURSED****
This is what you will do:
This position will serve the role of Engineer I for device development of client products including continuous product improvement within the Development function of client.
The candidate will support technical design and development activities for device and combination products and assist the technology transfer.
You will be responsible for:
"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.
"Consult 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.
You will need to have:
"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/ISO13485 quality system requirements).
"The duties of this role are conducted in a lab environment.
We would prefer for you to have:
"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.
Source : eTeam Inc.