Process Development Engineer II

Job Title: Process Development Engineer II

Department: Method Development

Status: Full Time - Exempt

Position

Purpose:

The Process Development Engineer II is responsible for developing, refining, and transferring manufacturing processes that support new product introduction and existing product improvements. This role applies engineering principles to design robust, scalable, and compliant processes while collaborating cross-functionally with R&D, Quality, Manufacturing, and Supply Chain. The Engineer II operates with moderate autonomy, contributes to technical problem-solving, and supports validation and documentation activities.

Key Responsibilities:

• Developing processes for the coating of customer medical devices within an ISO
  13485 Quality System.
• Author, review, and maintain controlled documentation in support of manufacturing and customer needs, including Design History Records, work instructions, and formal written and verbal guidance, in compliance with quality system requirements.
• Act as a technical point of contact for customers, leading engineering discussions and providing expert guidance on product and process capabilities.
• Lead the development and execution of validation test plans for coating methods, ensuring technical rigor, repeatability, and compliance.
• Compile and analyze data using statistical methods to generate reports from the execution of test plans.
• Support new product introduction (NPI) by establishing robust, repeatable, and scalable processes.
• Develop, define, and document new or improved processes for product development and manufacturing.
• Lead process development activities from feasibility through product transfer from development to manufacturing.
• Design and execute experiments (DOE) to optimize process parameters.
• Provide technical support to manufacturing during process transfer, ramp-up, and ongoing production.
• Identify and implement continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.
• Troubleshoot process issues and lead root cause analysis and corrective actions.
• Provide training and support to operators and team members on new processes, technologies, and best practices.
• Mentor and provide technical guidance to Development Process Engineer I and other technical staff.
• Identify and resolve process issues, facilitating root cause analysis and implementation of corrective actions.
• Ability to travel either to customer sites and/or to other Harland Medical Systems locations domestic or international for a period of time (20% frequency maximum).

Required Qualifications:

• Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial, Materials, or related field).
• 3-5 years of experience in process development, process engineering, or manufacturing engineering.
• Strong understanding of process characterization, validation, and statistical analysis.
• Experience with DOE, and root cause analysis tools.
• Ability to interpret technical drawings, specifications, and process flow diagrams.
• Strong problem-solving, analytical, and communication skills.
• Proven ability to lead and influence cross-functional teams.

Preferred Qualifications:

• Master’s degree in Engineering or a related technical discipline.
• Experience in regulated industries (e.g., medical devices, pharmaceuticals, aerospace, semiconductor).
• Familiarity with Lean Manufacturing, Six Sigma (Green Belt or Black Belt), or similar methodologies.
• Knowledge of regulatory standards such as ISO, FDA, or GMP (as applicable).

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.