Process Development Engineer
Pinnaql, Dorado, Dorado, United States
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Process Development Engineer
Description
The Process Development Engineer supports the development, validation, and implementation of new manufacturing processes. The role involves equipment and process validation, documentation generation, process optimization, and cross‑functional technical collaboration.
Requirements
5–7+ years in manufacturing engineering or quality engineering within an FDA‑regulated environment (medical devices, pharma, diagnostics, biotech).
Strong working knowledge of 21 CFR Part 820, GMP, and ISO 13485.
Electrical and mechanical engineering background applied to automated manufacturing systems.
Experience with automation/controls, tooling, fixtures, test method development, and equipment qualification.
Proficiency in DOE, FMEA, CAPA, and root‑cause investigation.
Experience supporting new product introductions and process scale‑up.
Responsibilities
Support IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.
Design and develop in‑process and receiving inspection systems for new components and processes.
Generate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.
Manage process development projects from concept through implementation; collaborate with cross‑functional teams.
Apply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.
Work with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
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Process Development Engineer
Description
The Process Development Engineer supports the development, validation, and implementation of new manufacturing processes. The role involves equipment and process validation, documentation generation, process optimization, and cross‑functional technical collaboration.
Requirements
5–7+ years in manufacturing engineering or quality engineering within an FDA‑regulated environment (medical devices, pharma, diagnostics, biotech).
Strong working knowledge of 21 CFR Part 820, GMP, and ISO 13485.
Electrical and mechanical engineering background applied to automated manufacturing systems.
Experience with automation/controls, tooling, fixtures, test method development, and equipment qualification.
Proficiency in DOE, FMEA, CAPA, and root‑cause investigation.
Experience supporting new product introductions and process scale‑up.
Responsibilities
Support IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.
Design and develop in‑process and receiving inspection systems for new components and processes.
Generate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.
Manage process development projects from concept through implementation; collaborate with cross‑functional teams.
Apply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.
Work with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
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