Engineer Senior

Position Summary:

Job Title: Senior Engineer
Location: Hybrid/Thousand, Oaks, CA
Duration: 16-18 Months (with possible extension)
Tax Term: W2
Top 3 Must Have Skill Sets:   
Experience performing data analysis using statistical software, (JMP, Minitab)
Experience modeling test fixtures, reference samples on solidworks or any other CAD software
Root cause analysis, CAPA deviation
Equipment method and test validation experience
Technical writing experience
Description:
Hybrid - MUST BE LOCAL TO USTO
Monday, Wednesday, Friday (Remote)
Tuesday, Thursday (On site) 8am - 5pm (flex) / 7am- 4pm
Job Summary
The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods for combination products, devices, primary container, and secondary packaging components, as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product, process, tooling or equipment introduction to improve product quality and reliability.
RESPONSIBILITIES:
• Assure transfer of new combination product test methods to QC or manufacturing, by developing six sigma processes and compiling all required documentation.
• Implement projects per Combination Product Operations (CPO) and company procedures to ensure projects are completed on schedule and within established budget.
• Apply core engineering principles to develop physical test methods for medical device and combination product systems.
• Perform data analysis to support method development, qualification, validation, and transfer
• Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes.
• Provide expert support for investigations as well as new processes development required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).
• Coordinate gauge and equipment development and delivery with selected contractors.
• Ensure that qualification parameters are met for product assembly and performance requirements.
• Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
• Generate procedures necessary to support department and new product equipment.
• Provide expert training to individuals in the operation and maintenance of processes, gauges and equipment introduced to the manufacturing department (i.e. production operator, mechanics, process engineers).
• Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). Supervise work of support staff during development and manufacture of system.
• Excellent communication (written and verbal) and organizational skills
• Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables
• Networks with manufacturing, quality and regulatory organizations both internal and external
• Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverables and impacts to risk.
• Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently
• Integrates partner/vendor timelines with timelines as appropriate
Preferred Qualifications:
• M.S. or Ph. D. in Mechanical, Aerospace, Mechatronics, Chemical or Biomedical engineering
• Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment
• Experience with managing technical teams, including setting priorities and leveling resources
• Technical writing experience
• Spanish language skills preferred
• Experienced with SolidWorks (or other 3D-CAD software)
• Familiar with equipment and software IOQ
• Experience with process characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs
• Experience with change controls, deviations, CAPA
• Experience with combination products and device regulatory requirements
• Understanding of the six sigma process, utilizing Minitab (or other statistical software packages) to solve statistical problems
• Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing
• Experience with machine controls (PLC, HMI) and vision systems
Basic Qualifications    
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Employee Value Proposition:   
Unique industry experience, opportunity
Interview Process:      
1st initial phone screen
2nd interview in person panel