Process Development Engineer

Description

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

Requirements

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

Benefits

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

Training + Development

Interview process

Visa Sponsorship

Security clearance