Role Summary

The Process Development Engineer will play a critical role in developing, optimising, and sustaining manufacturing processes for medical device production. This position requires strong hands-on engineering capability, experience working with toolshops, and expert skills in CAD-particularly SolidWorks-for tooling, fixtures, and equipment design. The role supports new product introduction (NPI), continuous improvement, and compliance with medical device regulatory standards.

Key Responsibilities

Process Development & Improvement

• Develop, validate, and optimise manufacturing processes for new and existing medical devices.
• Create and maintain process documentation including pFMEAs, control plans, work instructions, and validation protocols (IQ/OQ/PQ).
• Drive continuous improvement initiatives to enhance yield, reduce cycle time, and improve process capability.

Tooling & Fixture Design

• Design jigs, fixtures, gauges, tooling, and assembly aids using SolidWorks.
• Collaborate with internal and external toolshops to oversee fabrication, assembly, and commissioning.
• Conduct tool feasibility assessments and tolerance analysis to ensure manufacturability.

CAD & Engineering Documentation

• Generate detailed 3D models, 2D drawings, and engineering specifications.
• Manage revision control and ensure compliance with design control procedures.
• Support product design teams with DFM/DFA input.

Manufacturing Support

• Provide technical support to production teams, resolving process issues and leading root cause investigations.
• Implement corrective and preventive actions (CAPA).
• Support equipment qualification and process transfers to manufacturing sites.

Quality & Regulatory Compliance

• Ensure all processes and documentation meet ISO 13485, FDA, and other relevant medical device regulatory standards.
• Participate in risk assessments and contribute to regulatory submissions as required.

Required Qualifications & Experience

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline.
• Proven experience (3-7+ years) in process development within the medical device or regulated manufacturing environment.
• Strong proficiency in SolidWorks CAD design.
• Hands-on experience designing and developing tooling, jigs, fixtures, and automated or semi-automated equipment.
• Familiarity with toolshop practices, machining processes, tolerances, and material selection.
• Experience with validation activities (IQ/OQ/PQ) and process documentation.
• Strong understanding of DFM/DFA principles.

Preferred Skills

• Experience with GD&T, tolerance stack analysis, and engineering drawing standards.
• Knowledge of polymer processing, metal fabrication, or assembly automation.
• Exposure to Six Sigma, Lean Manufacturing, or statistical process control (SPC).
• Experience with ERP/PLM systems.
• Ability to manage multiple projects, deadlines, and cross-functional collaboration.