Manufacturing Engineer

Reporting To: Director of Operations / X40 Production Manager

Position

Purpose:

We are seeking a proactive and technically skilled Manufacturing Engineer to support and improve manufacturing processes applied to customer-supplied medical devices. This individual will be responsible for process improvement, leading root cause investigations, working closely with cleanroom operators across shifts, and serving as a key technical liaison with both internal teams and external customers. This role requires up to 25% international travel to support HMS production sites, audits, process transfers, and troubleshooting.

Responsibilities:

Production Support & Engagement

• Build strong relationships with production staff and foster a culture of collaboration and continuous improvement
• Monitor and adjust key process variables to ensure product consistency and high-quality output
• Assist with new process transfers from Method Development to Production

Process Improvement

• Continuously improve coating processes (e.g., dip, plasma)
• Apply Lean principles to manufacturing processes (eliminate waste in the manufacturing process and apply innovative systems to improve company workflows)
• Maintain and revise technical documentation including SOPs, work instructions, and validation of PQ protocols
• Perform internal audits on manufacturing lines
• Analyzing production data to identify areas for improvement in efficiency, cost, and quality.

Root Cause Analysis & Technical Problem-Solving

• Lead structured, cross‑functional, root cause investigations for coating‑related defects or process deviations using methodologies such as 5 Whys, Fishbone Diagrams, and DMAIC
• Act as the technical lead during customer escalations, investigations, and audits related to coating performance or compliance related to manufacturing
• Drive the implementation of corrective and preventive actions (CAPAs) and ensure timely documentation and communication of findings

Compliance & Documentation

• Ensure manufacturing processes comply with ISO 13485 and internal QMS requirements
• Support and lead validation activities for new and modified processes
• Maintain accurate and compliant documentation to support audits and regulatory inspections
• Implementing and monitoring quality control procedures to ensure products meet customer spec.

Support and/or perform other duties as required

Education, Qualifications &

Experience:

• Bachelor’s degree in Engineering (Mechanical, Industrial, Manufacturing) or a related field
• 5+ years of experience in manufacturing engineering, industrial engineering, or process engineering role, preferably in a regulated medical device or pharmaceutical environment
• Lean / Six Sigma Green Belt or higher preferred.
• Demonstrated expertise in leading root cause investigations and communicating findings directly to customers
• Experience working in or supporting cleanroom operations and collaborating with production operators
• Knowledge of coating processes and surface treatments for medical devices is strongly preferred
• Familiarity with process validation, GMP, and ISO 13485
• Excellent interpersonal and communication skills – comfortable interfacing with both customers and shop floor teams.
• Proficiency in CAD/CAM software (or similar):
  Ability to use computer-aided design and manufacturing software for design and simulation.

Working Conditions and Health & Safety:

• Heated and air‑conditioned office environment
• ISO Class 7 Cleanroom
• Laboratory
• Employee is required to use appropriate PPE including, but not limited to, nitrile or latex gloves, lab coat, hair bonnet, shoe covers, beard cover, safety glasses, hearing protection, face shield, or respiratory mask while working in a lab or manufacturing space.

Harland Medical System’s commitment to ensure employee health and safety is a priority. Personnel engaged in manufacturing shall obtain training required by ISO 13485, FDA 21 CFR part 820, FDA 21 CFR part 210 & 211, and Harland Medical System’s internal procedures, where deemed appropriate per assigned job functions.

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit for prolonged period of time. The employee is frequently required to talk and hear; use hands to handle or feel; and reach with hands and arms above shoulder height and below the waist. Using proper lifting techniques, the employee must be able to lift up to 40 lbs.