Application Engineer - Single Use Bag Solutions
$120,000–$150,000 year
On-siteCamarillo, California, United States
Job Summary
Translate customer specifications into engineering inputs, drawings, and bill of materials for single-use bag assemblies. Lead technical proposals, counterproposals, and make/buy analyses while collaborating with Sales and Manufacturing on design for manufacture and cost perspectives. Perform root cause analyses and corrective actions for product complaints, support new product introduction activities, and drive continuous improvement in design documentation. Provide technical guidance to less experienced engineers and ensure solutions meet regulatory and GMP compliance requirements. This role requires a Bachelor's degree in Engineering and 7+ years of experience in biotechnology or medical device manufacturing. Located in the U.S. with a salary range of $110,000–$140,000, this full-time position offers comprehensive benefits and potential sponsorship.
Required Qualifications
- Bachelor's degree in Engineering (Mechanical, Biomedical, Chemical, or related field)
- 7+ years of engineering experience in a biotechnology, pharmaceutical, or medical device manufacturing environment
- Experience with single-use bag design, assembly, and application engineering for bioprocessing
- Proficient in CAD software (2D and 3D) for building models and assemblies; able to create, read, and interpret technical drawings, BOMs, and specifications
- Experience performing or supporting make/buy analyses and supplier qualification/onboarding activities
- Strong customer-facing skills: able to present technical content, manage proposals, and drive technical alignment with external stakeholders
- Execution and documentation of Root Cause Analysis and corresponding Corrective Actions (RCCA, CAPAs)
- Experience working in a GMP (Good Manufacturing Practice) environment
- Project management and strong organizational and time management skills. Detail and deadline oriented
- Adaptable and capable of working in a fast-paced environment; high initiative, sense of urgency, with ability to work independently
- Strong work ethic with excellent verbal and written communication skills; ability to interact with staff at all levels within and external to the organization
- Proficient with Microsoft Office Suite
Desired Qualifications
- Master's degree preferred
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