Desired Skills:
§ Develop, review, and maintain validation documentation (plans, protocols, reports, procedures) for equipment, facility, and product validation, including supplier support; familiar with IQ/OQ/PQ protocols and reports.
§ Create and maintain inspection plans, PFMEAs, Control Plans, and process documentation for new and existing products; support new product launches for contract manufacturing.
§ Review and interpret engineering drawings, models, and production fixtures using SolidWorks and related tools; support engineering, manufacturing, and automation requirements.
§ Develop software-driven workflows and utilize digital tools such as Smartsheet, SharePoint, ERP systems, and Microsoft applications to manage change control and automate manual processes.
§ Manage databases such as the product contact material CAS database; ensure data accuracy and compliance.
§ Demonstrate proficiency in engineering and quality principles, including GD&T, MSA/Gage R&R, capability studies, and use of statistical tools like Minitab.
§ Collaborate with Estimators to produce customer product quotes and project documentation as needed.
§ Provide mentorship to junior engineers, fostering skill development in process engineering, problem-solving, and quality systems.
§ Exhibit strong problem-solving, analytical, and interpersonal skills; effectively communicate technical information and adapt to changing business priorities while working independently or leading teams.
Opportunities for Growth
Take ownership of cross-functional engineering and validation projects with exposure to advanced quality and manufacturing systems aligned with U.S. operations.
Deepen expertise in validation engineering, statistical data analysis, and workflow automation using Smartsheet, SharePoint, and ERP tools.
Build leadership by mentoring junior engineers, improving processes, and driving data-based decision-making across global teams.
Progress into senior roles such as Engineering Manager, or Technical Manager based on performance with leadership and mentoring opportunities.