Develop strong relationships with customers in the area of project management and technical development including sustaining project quotations, product design improvements, revalidations, quality requirements ensuring the cost considerations are evaluated and managed closely with the customer.
Ensure all Manufacturing Assembly taken on meet acceptable criteria with regard to financial, technical (including technical advancements), quality requirements, resources, etc.
Ensure Team engage GROWTTH® principles & Deploy tools to create simple, robust, and innovative manufacturing processes for new and sustaining products and strive to continually improve through the GROWTTH® methodologies.
Analyze test data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports as needed.
Provides the leadership, training, mentoring and work ethic expectations required for manufacturing engineering staff's development to ensure optimum performance is maintained and staff are motivated.
Leader on the Value Stream Management to identify priorities, budget, VSMs, savings opportunities etc in partnership with the GROWTTH Manager & Production Unit Managers.
Ensure the requirements of ISO 13485, ISO 45001, ISO 14001 and ISO 50001 are considered during production process improvements, sustaining activities and revalidation events.
Support maintenance and/or tooling dept. as needed to ensure the equipment is maintained in a manner that maximizes equipment life and performance
Provide technical support for design and process improvements to existing products & processes as required to meet customer need. (Some larger design changes maybe need to go back into R&D/NPI Ownership)
Ensure that sustaining manufacturing product(s) receive the necessary priority to meet or exceed customer expectations and business needs.
Support product failures and quality system investigations which includes but is not limited to audit findings, complaints, and field actions.
Supporting the production department with regard to process issues, CAPA’s, Change Management Process, Deviations, Customer complaints, supplier changes etc as and when required.
Managing and co-ordinating the acquisition of new equipment and tooling required for existing products, including test and measurement equipment in order to sustain the core assembly business with adequate equipment.
Supporting the Business Acquisition process (as required) in providing technical support, drawings/specifications, samples, costing data and other information that may be required to generate new business.
Supporting the business by interfacing early with the NPI department for new project transfers to production, ensuring there is early production input and support to get the product into production in as efficient and timely manner as possible.
Ensuring all activities are carried out according to the relevant Medical and Industry standards and internal procedures.
Provide accurate and up-to-date reporting on Scrap reduction projects and other sustaining projects/ vertical integration projects for insourcing of processes as required.
Demonstrate leadership and commitment with respect to the OH&S, Environmental and Energy Management Systems by developing, leading and promoting a culture which supports the intended outcomes of the management systems. Directing and supporting persons to contribute to the effectiveness of these management systems
Qualifications arrow_right
Required:
Level 8 bachelor degree in Polymer Science, Mechanical Engineering, Design or equivalent
Minimum 5 years in Medical Devices including manufacture of catheters and stents
Project Management capability and experience
Minimum 2 years in a people leadership position.
Professional and knowledgeable with ability to develop strong relationships with customers
Ability to work in a fast-paced environment ensuring team keeps pace with business needs.
