Manufacturing Engineer II

Job Title: Manufacturing Engineer II

Department: X40 – Coating Services

Status: Full Time - Exempt

Reporting To: Director of Operations / X40 Production Manager

Position Purpose:

The Manufacturing Engineer II owns coating process performance and production readiness for assigned processes. This role ensures processes are scalable, stable, and executable in production, leads process qualification activities, and supports process transfers and customer interactions (up to 25% travel).

Responsibilities:

Production Ownership

• Own coating process performance across production lines
• Monitor and adjust key variables to ensure consistency and quality
• Partner with operators to ensure processes are practical and repeatable

Process Improvement

• Lead Lean initiatives to improve yield, reduce waste, and increase throughput
• Analyze production data to identify and implement improvements
• Support process transfers from development into production

Root Cause & CAPA

• Lead structured root cause investigations (DMAIC, Fishbone, 5 Whys)
• Own CAPA implementation and effectiveness verification
• Support customer-related investigations and issue resolution

Process Transfer Support

• Support transfer of processes into production
• Identify gaps in scalability, operator usability, and process robustness
• Ensure processes are aligned to production conditions prior to release

Validation & Production Readiness

• Lead Process Qualification (PQ) to verify performance under production conditions
• Define PQ to include operator, shift, environmental, and material variability
• Partner with validation teams to ensure alignment between validated conditions and manufacturing needs

PVLT / OQ Influence (Non-Ownership)

• Review PVLT and OQ outputs to assess:
• Process windows
• Failure modes
• Control strategy robustness
• Provide feedback on scalability, operator sensitivity, and gaps vs production reality

Process Readiness & Risk Management

• Own readiness of assigned processes for production
• Identify, communicate, and drive resolution of process gaps
• Escalate significant risks impacting product quality or scalability

Documentation & Instruction Quality

• Own development and improvement of Work Instructions and SOPs
• Ensure documentation is clear, operator-focused, and repeatable
• Validate documentation effectiveness during PQ

Compliance & Audits

• Ensure compliance with ISO 13485 and GMP requirements
• Lead internal audits for assigned processes

Customer & Cross-Functional Collaboration

• Interface with customers on technical topics and investigations
• Collaborate with Quality, Operations, and R&D to support process performance

Support and/or perform other duties as required

Education, Qualifications & Experience:

• Bachelor’s degree in Engineering (Mechanical, Industrial, Manufacturing) or a related field
• 3–5 years of experience in manufacturing/process engineering
• Experience in regulated environments (medical device strongly preferred)
• 1+ years implementing LEAN systems preferred
• Strong root cause analysis and technical communication skills
• 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
• 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.