Senior Engineer - Aditi Consulting
Thousand Oaks, CA
About the 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.
Responsibilities:
Basic Qualifications:
Must Have Skill Sets:
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on a number of factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
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.
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.
Basic Qualifications:
- Doctorate Degree OR
- Master's Degree and 3 years of Engineering experience
- OR Bachelor's Degree and 5 years of Engineering experience
- OR Associate's degree and 10 years of Engineering experience OR
- High school diploma/GED and 12 years of Engineering experience.
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
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on a number of factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Source : Aditi Consulting