Medical Device Process Engineer
TPS Group LLC South San Francisco, CA
- Expired: over a month ago. Applications are no longer accepted.
Process Engineer III - BioTech Industry
Location: South San Francisco, CA
Pay Rate: DOE
Start Date: ASAP
6 Month Contract Role
Job Category: Medical Device
On behalf of our Biotech industry client we are seeking an '"Process Engineer III" for a 6 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.
The process engineer will manage the development and transfer of manufacturing processes for medical devices and drug device combination products at internal and external manufacturing sites. Job duties will include but are not limited to: manufacturability analysis, custom equipment procurement and qualification, process optimization using experimental design, process capability analysis, risk management, design transfer, and process validation.
- Management of contract manufacturing organizations.
- Collaboration with internal and external suppliers at a detailed technical level with design engineers, equipment, and production engineers.
- Transfer of device designs and test methods from development to commercial manufacturing.
- Review of technical reports including statistical analysis of data.
- Equipment procurement and qualification including GAMP5.
- Medical device development per 21CFR820.30 and ISO 13485.
- Risk management per ISO 14971.
- Semi-automated and automated equipment for sterile barrier and secondary packaging.
- Clean room manufacturing operations.
- Semi-automated and automated vision system inspections (development and validation).
- Experience with automated micro-assembly and adhesive bonding is desired.
- Internal quality assessments/audits, regulatory inspections, and notified body interactions.
- Discrepancy and change management.
Education & Experience:
- B.S, M.S, or advanced degree in engineering, with preference for mechanical or chemical engineering, or the equivalent.
- At least 8-10 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
- Proven track record of working effectively in a matrix organization with a highly cross functional (e.g., validation, quality, regulatory, and program management) and collaborative environment.
- Excellent oral and written communication skills.
- Excellent leadership skills.
- Success in project planning, resource management, and liaising with engineering and manufacturing resources, potentially in other countries.
Please submit your resume in Word or PDF version to be considered.
TPS Group LLC
The TPS Group, www.tpsmithgroup.com, is a Certified Woman and Disabled Owned Diverse recruiting and staffing firm that is a trusted recruiting partner to top companies.