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Applying for this role is straight forward Scroll down and click on Apply to be considered for this position.
This is an exciting opportunity to lead a multidisciplinary engineering team responsible for New Product Development (NPD), New Product Introduction (NPI), and Sustaining Engineering within a highly regulated manufacturing environment.
Reporting into senior leadership, you will play a key role in driving engineering excellence, delivering customer programmes, and supporting the successful introduction of innovative medical devices from concept through to commercial production.
This position offers the opportunity to work closely with global customers, influence business growth, and lead high-impact engineering initiatives across the full product lifecycle.
Key Responsibilities: Engineering Leadership Lead, mentor and develop a high-performing multidisciplinary engineering team across NPD, NPI and Sustaining Engineering.
Foster a culture of accountability, collaboration and continuous improvement.
Drive engineering performance to ensure projects are delivered safely, on time, within budget and to the highest quality standard New Product Development & Industrialisation Lead cross-functional product development activities from concept through design, verification, validation and transfer to manufacturing.
Oversee successful New Product Introduction (NPI), ensuring manufacturing readiness, process capability and robust product launches.
Drive design reviews, technical decision-making and risk management activities, including Design FMEA and Process FMEA.
Customer & Commercial Engagement Act as the primary technical point of contact for customers throughout development and commercial programmes.
Support technical proposals, RFQs and solution development.
Translate customer requirements into effective engineering execution plans.
Manage project scope, technical changes and customer communications throughout the project lifecycle.
Portfolio & Project Management Manage engineering project pipelines, resource planning and prioritisation.
Assess technical feasibility, project risks and resource requirements for new opportunities.
Balance engineering capacity against business priorities to ensure successful programme delivery.
Sustaining Engineering & Operational Excellence Lead sustaining engineering activities including design changes, product improvements and lifecycle management.
Drive continuous improvement initiatives focused on manufacturing efficiency, quality improvements and cost reduction.
Partner closely with Operations, Quality and Supply Chain teams to ensure stable, scalable production processes.
Quality & Regulatory Compliance Ensure engineering activities comply with ISO 13485, FDA regulations and applicable medical device standards.
Promote best practice in Design Controls, Risk Management and structured engineering processes.
Support regulatory audits and maintain compliance across engineering activities.
About You You are an experienced engineering leader with a proven track record of delivering complex medical device programmes within a regulated manufacturing environment.
You combine strong technical expertise with excellent leadership, customer management and commercial awareness.
Essential Requirements Bachelor's degree in Engineering or a related discipline.
Minimum 10 years' experience within medical device engineering, including New Product Development.
At least 5 years' experience leading engineering teams.
Strong knowledge of Design Controls, product development processes and regulatory requirements.
Experience managing NPI and product industrialisation activities.
Proven success leading sustaining engineering and continuous improvement initiatives.
Experience implementing Lean Manufacturing, Six Sigma and structured problem-solving methodologies.
Excellent communication, leadership and stakeholder management skills.
Desirable Experience Previous experience within a medical device contract manufacturing environment.
Customer-facing engineering or programme management experience.
Commercial awareness including costing, scope management and change control. xyswxtq
Experience with ERP systems and advanced manufacturing technologies.
For a confidential conversation about the role please apply for the role or contact Owen Clancy at By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
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