Principal Process Engineer- Medical Device Start-up

Principal Engineer - Process Development Role Overview The Principal Engineer - Process Development will lead manufacturing engineering activities, own process development for new devices, and drive continuous improvement across production systems. This role requires a hands-on engineer who thrives in a fast-paced environment, enjoys cross-functional collaboration, and is motivated by delivering high-impact projects that directly benefit patients. Key Responsibilities Process & Equipment Validation Lead equipment and process validations (IQ/OQ/PQ). Support and oversee supplier-led process validations. Lead test method development and validation activities. Documentation & Technical Leadership Generate and maintain high-quality process documentation. Manage, mentor, and develop the Manufacturing Engineering team. Serve as the subject matter expert for all manufacturing engineering activities. Labelling & Compliance Lead the design, implementation, and compliance of product labelling systems. Manage label creation using platforms such as BarTender (or equivalent). Establish robust Unique Device Identification (UDI) standards and barcode verification processes. Process Optimisation & Manufacturing Systems Lead line balancing, layout redesign, and process flow improvements using Lean Six Sigma tools. Design and develop jigs and fixtures to improve yield, throughput, and error-proofing. Identify and implement automation/semi-automation solutions for commercial-scale output. Lead manufacturing-related CAPAs to ensure long-term, robust corrective actions. Support investigations of manufacturing-related complaints or returned devices. Cross-Functional Collaboration Work closely with R&D teams on Design for Manufacture (DFM) improvements. Initiate process controls and data collection systems enabling real-time yield feedback. Plan and manage timelines for manufacturing engineering projects. Partner with external manufacturing organisations to ensure alignment on time, cost, and quality expectations. Drive continuous improvement of all manufacturing processes. Tools & Technical Skills Use 3D CAD tools (e.g., SolidWorks) and in-house prototyping equipment (e.g., 3D printing) to design fixtures and assembly aids. Consistently deliver on quality, cost, and timeline commitments. Build strong working relationships with suppliers and manufacturing partners. Personal Attributes The ideal candidate is: Creative: Enjoys solving complex problems and bringing forward new ideas. Open: Adapts to evolving team culture, gives and receives constructive feedback. Communicative: Strong verbal and written communication skills; able to clearly articulate technical ideas. Self-Driven: Works with urgency and independence, demonstrates strong ownership, and pursues personal development. Organised: Manages competing priorities effectively and consistently meets deadlines. Team-Oriented: Thrives in multidisciplinary environments working toward shared goals. Required Qualifications & Experience Engineering or relevant technical degree. 8+ years relevant experience in a manufacturing environment, including at least 5 years in the medical device industry in roles such as: Senior Manufacturing Engineer Senior Process Development Engineer Project Engineer Or equivalent technical positions Technical Experience Must Include: Working within an ISO 13485 or equivalent quality system. Experience with PCB and/or electromechanical component processing. Designing and configuring assembly areas to optimise throughput. Experience in startup or SME environments. Equipment installation and validation. Supporting supplier process validations (e.g., injection moulding, heat sealing, bonding). Experience with line installations or manufacturing line transfers. Lean Six Sigma experience (minimum Green Belt). Leading root-cause investigations and CAPA processes. Applying statistical methods for process analysis. People management experience. Experience with cleanroom manufacturing (advantageous but optional). Supplier Engagement Comfortable managing external suppliers and manufacturing partners. Preferred / Advantageous Experience Master's degree or advanced technical diploma. Experience with polymer processing in a cleanroom environment. Lean Six Sigma Black Belt certification At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details. Privacy Policy: By applying for this role you are agreeing that your details will be stored in our database and may be considered for similar future positions. For more info see Skills: Process Engineer Manufacturing Medical Devices Process Improvements Validation