Develops and modifies processing or handling equipment requirements and specifications, and reviews processing techniques for manufacture of new products and to decrease cost, improve throughput, and improve overall quality for commercial product lines. Transfer and scaling of products from San Diego manufacturing site. Provide manufacturing support to identify and resolve complex technical issues. This Senior Engineer position will be highly involved with the manufacturing of sensor applicator devices and sterile barrier packaging.
Essential Duties and Responsibilities:
- Lead/participate in process development, product transfer, and process improvement projects to improve product quality, decrease cost, and improve manufacturing efficiencies.
- Develop test plans, validation IQ/OQ/PQ protocols, test protocols. Execute protocols and write reports to ensure equipment/processes meet part/assembly
- Applies statistical methods to estimate future manufacturing requirements, production and field performance data to identify issues and opportunities for improvements.
- Develops and maintains project timelines and provides updates and feedback to project leadership.
- Accomplishes tasks while conforming to the company quality system procedures.
- Excellent written and verbal communication skills.
- Competent in design, execution, data analysis, and interpretation of experiments.
- Equipment Qualification (IQ,OQ,PQ) experience
- High throughput automation experience
- Equipment Maintenance/Mechanical knowledge
- Good Manufacturing/GMP knowledge
- Calibration knowledge and understanding
- Vision System experience
- Process Development experience
- Proven track record in the commercialization and manufacture of medical devices and/or medical diagnostic products preferred.
- Master’s degreepreferred in Chemical Engineering, Bioengineering, Mechanical Engineering or related field.
- Bachelor’s degree or higher in Chemical Engineering, Bioengineering, Mechanical Engineering or related field required.
- Typically requires a minimum of 5 years of related experience or 3 years with Master Degree.