Job Title: Manufacturing Engineer I
Department: Coating Services
Status: Full Time - Exempt
Reporting To: Director of Operations / X40 Production Manager
Position Purpose:
The Manufacturing Engineer I supports coating manufacturing processes within production, focusing on learning process fundamentals, supporting operations, and contributing to process improvement and readiness activities. This role works closely with operations, quality, and senior engineers and may support global sites (up to 25% travel).
Responsibilities:
Production Support
- Support daily coating operations
- Monitor process parameters and escalate deviations or quality issues
- Collaborate with operators to understand process execution, variability, and challenges
Process Improvement
- Support Lean and continuous improvement activities
- Collect and analyze production data under guidance
- Assist in improving yield, quality, and efficiency
- Support identification of gaps between validated conditions and production reality
Problem Solving
- Participate in root cause investigations using basic tools (5 Whys, Fishbone)
- Support CAPA implementation
Process Transfer Support
- Support process transfer activities into production
- Learn key considerations for production readiness, including scalability and operator usability
Validation & Process Readiness
- Support Process Qualification (PQ) activities under guidance
- Review PVLT and OQ documentation to understand process intent, limits, and potential risks to production
- Help identify gaps between validated conditions and actual production execution
- Provide feedback on operator usability and process clarity
Documentation & Instruction Quality
- Support development and improvement of Work Instructions and SOPs
- Learn to identify unclear or non-repeatable process steps
- Support updates to documentation based on PQ findings and early production feedback
Compliance
- Follow ISO 13485 and Quality Management System requirements
- Support audit readiness activities
Support and/or perform other duties as required
Education, Qualifications & Experience:
- Bachelor’s degree in Engineering (Mechanical, Industrial, Manufacturing, or related)
- 1–3 years of relevant experience (internships/co-ops count)
- Basic understanding of manufacturing processes
- Strong problem-solving and communication skills
- Exposure to regulated environments preferred
- Excellent interpersonal and communication skills – comfortable interfacing with shop floor teams.
- 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.