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Sustaining Engineer (M/F/D)
Tasks:
Provide support to products post launch, coordinating design and manufacturing changes and improvements to meet defined specifications (esp. device and manufacturing requirements)
Accept design authority following product launch and release into production. Ensure efficient ongoing transition into ongoing production by appropriate provision of a design authority service to operations and quality.
Assessment of Non Conformance Reports (NCRs) and implementation of agreed corrective / preventive actions to maintain regulatory compliance
Maintain a strong and current understanding of relevant new product development and manufacturing technologies and their application to medical device design to meet or exceed customer, company and project needs
Evaluation and documentation of the feasibility, reliability and risk of concepts and / or prototypes through engineering testing and analysis in order to demonstrate that the product performance, manufacturability, safety and cost are consistent with the customer, regulatory and production requirements
Develop timelines, cost and resource estimates for product changes and appraise management of performance against plan, communicating and reporting progress to project management to maintain and track compliance to project schedule
Generate, modify and review design history file documentation in compliance with relevant regulatory requirements e.g. Quality System Regulations (QSR), Good Manufacturing Practice (GMP), International Standards Organisation (ISO) and in accordance with company development standards (e.g. PDD, TDP) throughout the product life cycle to ensure the design is fully documented
To be responsible for contact to internal and external project sponsors with respect to company products to ensure maintenance of product line and communication and buy in of design change implementation where required
Progress vendor activities in agreement with global sourcing relative to communication of specifications, development schedules and tracking in order to obtain components, supplies or equipment to support prototype or product procurement and assembly
Deliver manufacturable designs acceptable to operations by applying design for manufacture principles, implement and communicate feedback from manufacturing engineers, external suppliers and other sources to the R&D engineer
Ensure a high product and process quality in collaboration with the quality department and all other departments
Qualification:
Bachelor’s or Master’s degree in Engineering or equivalent professional education / long years of experience
Some years of experience in a regulated and highly industrial or scientific engineering design environment
Project experience
Experience in change management and non conformity handling for medical devices
Understanding of a wide range of engineering technologies used in design and manufacturing
Strong problem solving skills
Understanding interfaces between functions, understanding the needs of others
English and German on a professional level needed
Requirements:
Start: asap
Duration: 6 months
Capacity: 4 days per week
Location: remote
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