Sr Process Engineer
Sr Process Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Process Technologies: Lead the exploration and development of new process technologies that may be incorporated into new product development projects or existing manufacturing lines. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
- Process Development: Lead new product development by designing and developing manufacturing processes for new products that facilitate ease of manufacturing while producing quality cost effective products with optimized yields. Such activities include but are not limited to the following:
- Manufacturing Studies: Work with engineering team on studies to characterize process inputs to drive development of critical manufacturing/process specifications that are both robust and meet quality expectations Use appropriate statistical support and Design of Experiments (DOE).
- Equipment and Fixture Development: Identify equipment and fixture needs within pilot line and/or manufacturing operations.
- Documentation: Generate required documentation in support of manufacturing products and processes. These include engineering protocols/reports PFMECAs and manufacturing instructions. Ensure compliance with internal procedures GMP and regulations.
- Qualification and Validation: Generate and execute plans for equipment qualification and process validation. Lead test method development and validation where needed.
- Previous medical device experience.
- Solid understanding of statistical techniques and analysis.
- Design for Reliability and Manufacturability (DRM) experience.
- Demonstrated computer skills such as Minitab Excel Word and Project.
- Process Validation (IQ/OQ/PQ) and Test Method Validation experience.
- Executes Robust Process Development utilizing DOEs IQ OQ PQ.
- Detailed work instructions.
Employment Type
Full-time
