Senior Manufacturing Engineer

Senior Manufacturing Engineer


Our client a startup medical device start up are currently seeking a Senior Manufacturing Engineer to join their team. Reporting to NPI Program Manager The Senior Manufacturing Engineer will support the manufacturing of a novel medical . The Senior Manufacturing Engineer will support build operations and be responsible for the planning model to identify resource and training needs for operators / product builders.


Role/Responsibilities:

• Generation / implementation of operational planning models to clearly identify resource and training requirements across all production areas. Working closely with R&D to capture demand forecast to prospectively plan resources and on-boarding.
• Plan and manage daily activities of operators to achieve seamless production of high quality product with high efficiency resource utilisation.
• Supervision of employees and manufacturing activities as relates to the production of sub-systems.
• Act as production cross-functional team member in identifying, selecting and resourcing improvement projects (yield, quality, capacity). The work will be performed in close collaboration with New Product Introduction and Quality.
• Develop full understanding of manufacturing procedures, processes and equipment used.
• Generate and maintain data for managing our business, e.g. method studies, time & motion studies, and work content graphs.
• Updates to Device Master Record documents maximise efficiencies while remaining in compliance to internal quality procedures, standard and regulatory requirements. Implement, where appropriate, standardisation of work methods across all production areas.
• Analyse and identify potential line layout adjustments to improve efficiency and product quality
• Accountable for ensuring staff are appropriately trained to perform assigned work by planning the training schedule and delegating the training to appropriate operations / quality staff.
• Accountable for operations metrics (including operator metrics such as performance, absenteeism, punctuality) and for providing regular progress reports to management and cross-functional stakeholders.
• Accountable for inventory control, including identifying inventory requirements, as well as tracking material usage and ensuring stock for manufacturing campaigns. Remain up-to-date on supply-chain challenges and bottlenecks to burn down risks of inventory constraints – across all manufacturing areas.
• Partner with NPI engineering and quality functions on investigations and/or corrective actions, perform non-conformance investigations for review with engineering, assure documentation content is correct.
• Initiate and sustain Kaizen /continuous improvement.
• Promote and instil a culture on “Right-First-Time” and driving efficiency.
• Ensure that a high standard of compliance with GMP is maintained in the manufacturing areas.
• Understanding of EHS rules and requirements and drives identification and implementation of adequate control measures.
• Ensure Company Goals and Values are considered in all activities and interactions.

• Degree level qualified in production or industrial engineer, or equivalent.
• Minimum 5 years previous medical device experience, or equivalent.
• Familiarity with intricate manual assembly techniques, including knowledge of materials and manufacturing processes typically applicable to medical device manufacture.
• Hands-on experience in production line set-up. Utilisation of lean principles would be an advantage to support prospective planning.
• Minimum 3 years direct experience in supervision of operators / product builders, with full responsibility for all operator personnel including people management and handling all aspects of employee relations in manufacturing.
• Demonstrated ability to supervise teams and provide coaching and feedback.
• Experience working in multi-cultural teams.
• Excellent communication and relationship skills with experience working in cross-functional teams.
• Ability to work within a fast paced, dynamic, and constantly changing work environment.
• Proven expertise in Microsoft Office Suite, and similar on-line tools. Particular focus on planning tools (MS Project, Smartsheet) in their application to production and resource planning.
• Working knowledge of FDA, GMP, QSR and ISO 13485 requirements is an advantage.
• Project management experience and experience of ERP / MRP systems, as related to production planning, is an advantage.