Company: Hammill Manufacturing Co.

Job Title: Mechanical Engineer - Manufacturing Process

Location: Maumee, Ohio

Job Duties:

The Mechanical Engineer will review and optimize manufacturing processes for the production of implantable medical devices and instruments, ensuring compliance with regulatory standards and operational efficiency. Primary duties include: conduct detailed audits and analyses of precision, production machining to identify inefficiencies and adherence to FDA regulations, ISO 13485 and Good Manufacturing Practices; perform root cause and SPC investigations to recommend improvements that reduce defects, minimize downtime, and enhance yield rates; collaborate with cross-functional teams to implement lean manufacturing and automation techniques; execute process validation studies (IQ/OQ/PQ), failure mode and effects analysis, and capability assessments to support production; develop and maintain standard operating procedures and work instructions to standardize processes and facilitate employee training; monitor key performance indicators such as cycle time, cost per unit, and defect rates and generate technical reports to present to management; and research industry advancements in technologies for medical devices and regulatory updates to adapt processes for continuous improvement.

Minimum Requirements:

Bachelor's degree in Mechanical Engineering or related field.

36 months of experience in Mechanical Engineering

Demonstrated experience and proficiency in SolidWorks, AutoCAD, and 3D CAD modeling along with prior application of ANSI and GD&T standards; proficiency in analytical tools (e.g., MATLAB), and industrial control software.

How to apply:

All applicant resumes must reference above job title and be submitted to:

Jonathan Rantala

360 Tomahawk Drive

Maumee, Ohio 43537

Jonathan.rantala@HammillMfg.com

HAMMILL MANUFACTURING CO

Latest Jobs

Mechanical Engineer