We are seeking a skilled Senior Manufacturing Engineer with 5+ years of experience to join our team. The ideal candidate will have expertise in managing and optimising contract manufacturing processes. This role involves working closely with contract manufacturers to ensure that products are produced efficiently, meet quality standards, and are delivered on time and within budget.
RESPONSIBILITIES
Contract Manufacturing Management
- Develop and maintain strong relationships with contract manufacturing partners to ensure alignment with company requirements and standards.
- Oversee and manage the entire contract manufacturing process, execution, and continuous improvement initiatives.
- Coordinate with contract manufacturers to address and resolve production issues and implement corrective actions as needed.
- Research, justify and propose capital equipment and/or processes investments.
- Liaise with the Sourcing group to identify new suppliers as needed and to identify and capitalize on opportunities for the reduction of cost, yield, or quality improvements with existing or new vendors, via process improvement or transfer.
- Coordinate with Purchasing and Quality Engineering to improve the Quality Systems procedures relating to suppliers.
Process Optimization
- Collaborate with internal teams to review and optimize manufacturing processes and product designs to enhance efficiency and reduce costs.
- Analyse production data and metrics to identify areas for improvement and implement solutions to optimize manufacturing operations.
- Perform process capability assessments and develop strategies to improve yield and reduce defects.
- Provide input and guidance to new product Introduction teams on best practices for MFG production, test and packaging processes and procedures.
Quality Assurance
- Develop and implement quality control procedures to ensure products meet design specifications and industry standards.
- Liaise with Supplier Quality Engineering and Sustaining Engineering (CAPA) to ensure the effective completion of Supplier Corrective Actions. Support the assessment of non-conforming products received from suppliers.
- Provide technical support and input when required to the Suppler Audit process and liaise with Suppliers and Regulatory Assurance to obtain the supplier related information required for regulatory submissions.
Project Management
- Lead manufacturing projects from initiation through to completion and resource allocation.
- Prepare and present project reports, including progress updates, performance metrics, and recommendations for improvements.
- Ensure projects are executed on time, within scope, and within budget constraints.
Technical Support
- Provide technical guidance and support to contract manufacturers regarding manufacturing processes, equipment, and materials.
- Troubleshoot and resolve technical issues related to production processes, equipment performance, and product quality.
- Gives technical guidance to Associate Engineers, technicians and production employees.
Compliance and Documentation
- Ensure that all manufacturing activities comply with industry regulations, company policies, and safety standards.
- Maintain comprehensive documentation related to manufacturing processes, quality control measures, and project activities.
- Develops and executes validation protocols (e.g. IQ, SV, TMV, MVP, MVR) in compliance with regulatory requirements.
- Develops manufacturing procedures to support transferred manufacturing processes.
- Reviews and approves documents prepared by sister sites or contractor (e.g. Tool Validation report, Risk Assessments, Change Notes).
QUALIFICATION REQUIREMENTS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
- Formal Production/Engineering qualification and relevant experience in at least one of the following areas: Manufacturing, Supplier Engineering, Engineering/Device Design & Development.
- 5+ years of medical device experiences supporting manufacturing, engineering, or quality, regulatory and/or compliance capacity.
- Strong knowledge and demonstrable experience of working to medical device quality standards ISO13485/FDA practices and similar regulated industry standards.
- Project Management and problem-solving skills
- Proficiency in engineering software and tools (e.g., CAD, ERP systems).
Travel Required: You will be required to travel from time to time with this role.
Benefits
- A competitive salary package.
- Defined Contribution pension plan
- Comprehensive Healthcare & Life Assurance coverage
- Additional benefits such as income protection and death in service-service benefit.
- Health & Wellbeing Events
- Recognition Scheme
- Free Parking
- Educational assistance
EEO Statement
Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.