Responsibilities:
- Work with combination products and the associated life-cycle maintenance activities. This includes Design Transfers, Periodic Risk Review Reports, Design History File (DHF) Remediation and commercial manufacturing support for combination products. Activities may include:
o Performing gap assessments on existing DHFs against SOPs and standards
o Updating relevant documents within the DHF
o Performing impact assessments for design changes
o Working with different functions such as; device development, device quality, device regulatory, drug product, packaging, and human factors
Qualifications:
- BSC. in Mechanical, Chemical, or biomedical engineering or related engineering/scientific field.
- Experience with development and life cycle management of combination products and medical devices.
- Experience supporting on-market biological combination products is a plus
- Experience in biotech/pharmaceutical or medical device company
Job Type: Contract
Salary: $60.00 - $70.00 per hour
Schedule:
Ability to commute/relocate:
- Gaithersburg, MD 20878: Reliably commute or planning to relocate before starting work (Required)
Work Location: In person
