Process Development Engineer

Overview

Lead catheter process development, validation, and quality improvement.

Key Responsibilities

• statistical analysis
• process development
• equipment validation
• process optimization
• test development
• equipment calibration

Tasks

-Utilize Minitab for data analysis, DOE, SPC, and capability studies. -Contribute to injection molding and extrusion process development as needed. -Conduct IQ/OQ/PQ validations for manufacturing equipment and ensure compliance with regulatory standards. -Document and maintain technical reports, protocols, and validation documentation. -Support and troubleshoot inspection equipment and ensure proper calibration and functionality. -Collaborate with cross-functional teams to optimize manufacturing processes and improve yield and efficiency. -Develop and validate test methods to ensure product performance and reliability. -Perform process characterizations using statistical tools and methodologies. -Lead process development activities for catheter manufacturing, including prototyping, scale-up, and transfer to production.

Requirements

• minitab
• inspection equipment
• engineering degree
• six sigma
• iq/oq/pq
• project management

What You Bring

-Strong knowledge of statistical analysis and Minitab software. -Familiarity with inspection equipment and quality control tools. -Excellent communication skills and a strong work ethic. -Bachelor’s degree in Engineering (Mechanical, Biomedical, or related field). -Experience in process improvement, process engineering, continuous improvement, lean manufacturing, and Six Sigma. -Hands-on experience with IQ/OQ/PQ, test method validation, and process characterization. -3+ years of experience in medical device manufacturing, preferably in catheter development. -Proficiency in project management and equipment validation.

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Benefits

-9 paid holidays (including your birthday!) + PTO and Personal days -401k plan with a company match -Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance -Employer paid dental insurance -Gym membership subsidy -Employer subsidized health insurance for employees -Employer HSA contribution

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

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