Kaztronix
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http://www.kaztronix.com
http://www.kaztronix.com
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Process Engineer
Job Description
Process Engineer Role Description
Overview
Seeking a Process Engineer to support the design, development, optimization, and scale-up of manufacturing processes for medical device and drug-delivery components. The contractor will work with cross-functional teams and suppliers to deliver robust, manufacturable solutions.
Key Responsibilities
- Develop, optimize, and validate component and assembly manufacturing processes.
- Support DFM/A activities and translate product requirements into process outputs.
- Conduct process characterization, capability studies, and statistical analyses.
- Partner with R&D, Quality, Regulatory, Supplier Engineering, and Operations throughout development.
- Support equipment debug, characterization, FAT, and qualification activities.
- Troubleshoot manufacturing and compliance issues and support process transfer to production sites. Preferred Background - 6+ years in process development within a regulated industry.
- Strong understanding of component fabrication and assembly processes.
- Experience with DFMA, FMEA, and applied statistics (MSA, process capability).
- Experience with equipment commissioning (debug, characterization, FAT, validation).
- Familiarity with Lean, Six Sigma, or similar methodologies.
- Experience supporting commercialization or working with global teams/suppliers.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
- Support DFM/A activities and translate product requirements into process outputs.
- Conduct process characterization, capability studies, and statistical analyses.
- Partner with R&D, Quality, Regulatory, Supplier Engineering, and Operations throughout development.
- Support equipment debug, characterization, FAT, and qualification activities.
- Troubleshoot manufacturing and compliance issues and support process transfer to production sites. Preferred Background - 6+ years in process development within a regulated industry.
- Strong understanding of component fabrication and assembly processes.
- Experience with DFMA, FMEA, and applied statistics (MSA, process capability).
- Experience with equipment commissioning (debug, characterization, FAT, validation).
- Familiarity with Lean, Six Sigma, or similar methodologies.
- Experience supporting commercialization or working with global teams/suppliers.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
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