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

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  Lead equipment and process validations (IQ/OQ/PQ).
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  Support and oversee supplier-led process validations.
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  Lead test method development and validation activities.

Documentation & Technical Leadership

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  Generate and maintain high-quality process documentation.
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  Manage, mentor, and develop the Manufacturing Engineering team.
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  Serve as the subject matter expert for all manufacturing engineering activities.

Labelling & Compliance

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  Lead the design, implementation, and compliance of product labelling systems.
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  Manage label creation using platforms such as BarTender (or equivalent).
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  Establish robust Unique Device Identification (UDI) standards and barcode verification processes.

Process Optimisation & Manufacturing Systems

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  Lead line balancing, layout redesign, and process flow improvements using Lean Six Sigma tools.
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  Design and develop jigs and fixtures to improve yield, throughput, and error-proofing.
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  Identify and implement automation/semi-automation solutions for commercial-scale output.
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  Lead manufacturing-related CAPAs to ensure long-term, robust corrective actions.
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  Support investigations of manufacturing-related complaints or returned devices.

Cross-Functional Collaboration

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  Work closely with R&D teams on Design for Manufacture (DFM) improvements.
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  Initiate process controls and data collection systems enabling real-time yield feedback.
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  Plan and manage timelines for manufacturing engineering projects.
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  Partner with external manufacturing organisations to ensure alignment on time, cost, and quality expectations.
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  Drive continuous improvement of all manufacturing processes.

Tools & Technical Skills

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  Use 3D CAD tools (e.g., SolidWorks) and in-house prototyping equipment (e.g., 3D printing) to design fixtures and assembly aids.
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  Consistently deliver on quality, cost, and timeline commitments.
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  Build strong working relationships with suppliers and manufacturing partners.

Personal Attributes

The ideal candidate is:

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  Creative: Enjoys solving complex problems and bringing forward new ideas.
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  Open: Adapts to evolving team culture, gives and receives constructive feedback.
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  Communicative: Strong verbal and written communication skills; able to clearly articulate technical ideas.
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  Self-Driven: Works with urgency and independence, demonstrates strong ownership, and pursues personal development.
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  Organised: Manages competing priorities effectively and consistently meets deadlines.
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  Team-Oriented: Thrives in multidisciplinary environments working toward shared goals.

Required Qualifications & Experience

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  Engineering or relevant technical degree.
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  8 years relevant experience in a manufacturing environment, including at least 5 years in the medical device industry in roles such as:
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    Senior Manufacturing Engineer
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    Senior Process Development Engineer
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    Project Engineer
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    Or equivalent technical positions

Technical Experience Must Include:

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  Working within an ISO 13485 or equivalent quality system.
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  Experience with PCB and/or electromechanical component processing.
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  Designing and configuring assembly areas to optimise throughput.
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  Experience in startup or SME environments.
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  Equipment installation and validation.
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  Supporting supplier process validations (e.g., injection moulding, heat sealing, bonding).
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  Experience with line installations or manufacturing line transfers.
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  Lean Six Sigma experience (minimum Green Belt).
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  Leading root-cause investigations and CAPA processes.
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  Applying statistical methods for process analysis.
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  People management experience.
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  Experience with cleanroom manufacturing (advantageous but optional).

Supplier Engagement

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  Comfortable managing external suppliers and manufacturing partners.

Preferred / Advantageous Experience

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  Master's degree or advanced technical diploma.
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  Experience with polymer processing in a cleanroom environment.
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  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.

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