Associate Engineer, Device Development - BioTech Industry
Location: South San Francisco, CA
Pay Rate: DOE
Start Date: 6/25/2020
12 Month Contract Role (Strong Potential to Convert or Extend)
Department: Device Development
Job Category: Medical Device
On behalf of our BioPharma industry client we are seeking a '"Associate Engineer" for a 12 month contract assignment. We are working with a global biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases.
- Execute GMP Testing Protocols (Design Verification, Test Method Validation, and Complaints Investigations) using knowledge of Design Requirements, Validated Test Methods, and analytical instruments.
- Record GMP Data in Laboratory Notebook and Document Control systems
- Review GMP data for technical accuracy, completeness, and cGDP compliance.
- Execute R&D / characterization testing or special test requests as needed to support the development and selection of device designs, components, test methods or operating procedures.
- Collection of mechanical testing data to aid in the characterization, selection, design verification, and commercialization of drug delivery devices.
Skills / Education:
- BS/BA in an engineering or life sciences field (mechanical, biological, biomedical, chemical)
- 0-2 yrs of experience in the Pharmaceutical, Biotech, or Medical Device industry or an equivalently-regulated research/development environment (e.g. ISO compliant) is required.
- Experience in R&D and GMP environments is desired, and an understanding of the differences between these environments is critical.
- Direct experience in executing physical/functional Test Methods and following SOPs / Protocols is highly desired.
- Familiarity with tensile/torque testing systems is highly desired (Instron, Zwick, Mecmesin).
- Familiarity with dimensional analysis/metrology equipment is highly desired (Microscopes, Gages, Calipers, Vertex).
- Familiarity with Operational Excellence Initiatives, Lean Six Sigma, 5S, Kaizen, and/or Value Stream Mapping is a plus.
Please submit your resume in Word or PDF version to be considered.