Process Development Engineer

Description

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

Requirements

• Familiarity with inspection equipment and quality control tools.
• Proficiency in project management and equipment validation.
• Excellent communication skills and a strong work ethic.
• 3+ years of experience in medical device manufacturing, preferably in catheter development.
• Bachelor’s degree in Engineering (Mechanical, Biomedical, or related field).
• Strong knowledge of statistical analysis and Minitab software.
• 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.

Benefits

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

Training + Development

Interview process

Visa Sponsorship

Security clearance