Senior Manufacturing Process Engineer
Job Description
The Senior Manufacturing Process Engineer, as a member of the Technical Operations team, oversees the development of manufacturing processes and procedures. Specific areas of focus include working with manufacturing, quality, and product engineering to achieve continuous product and process improvements. The Senior Manufacturing Process Engineer will have a leading and influential role to bring product through development and into production. The Senior Manufacturing Process Engineer will drive the development and deployment of robust manufacturing processes meeting metrics on safety, cost, quality and supply. This scientist will be impactful by leveraging their proficient knowledge of product and process development, manufacturing scale up, compliance, continuous process improvement and troubleshooting processes in the design transfer, commercialization, and optimization of novel in vitro diagnostic tests.
Responsibilities
- Manage design, implementation, system integration, verification and validation of manufacturing processes and equipment.
- Take ownership of all manufacturing processes and equipment. Troubleshoot and find solutions to problems.
- Provide new ideas for process improvements. Test ideas and provide recommendations in a timely manner.
- Take charge of the transfer of new products from R&D to commercial manufacturing.
- Responsible for developing processes, structured BOMs, well-written manufacturing instructions and setup of manufacturing lines.
- Define and own key performance indicators (yield. CpK, cost, etc) is support of the new product development process. Driving improvement action plans if such actual performance is not meeting established targets.
- Qualify and deploy appropriate metrology into production.
- Support and monitor new product development for adherence to the internal quality management design control system and compliance to all ISO, FDA and QSR regulations
- Provide regulatory compliance input to the Operations team on quality issues arising during process improvements and risk updates.
- Facilitate alignment among development, supplier quality, and supply chain groups to ensure product suppliers are effectively developed.
- Conduct root cause analysis to support nonconformance and CAPA investigations.
Job Requirements
- Bachelor of Science in Mechanical, Electrical, Bio Medical or related field
- 8 years professional experience as a manufacturing or process engineer
- 8 years experience leading technical teams
- Experience with molecular diagnostics
- Experience developing, characterizing and troubleshooting reagent manufacturing processes
- Demonstrated ability to understand and effectively work across multiple functions
- Demonstrated leadership skills, including ability to organize, clarify and influence others
- Effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel
- Use of data analysis to drive improvement - working knowledge of statistical tools and manufacturing methodologies (FMEA, RCA, SPC, DOE, Lean, Six Sigma)
- Strong documentation skills
- Take initiative and have the ability to conduct hands-on work
- Possess the ability to handle multiple tasks with superior attention to detail
Nice to haves:
- Working knowledge of FDA Regulations and Good Manufacturing Practices, ISO 13485 and CLIA regulations
- Method validation
- Automation
