Equipment Development Engineer (2-year contract)
One of our client, specializing in Medical Devices, is looking for a :
Be flexible to travel up to 30% of the time to visit manufacturing sites, third-party vendors, and participate in on-site testing and validation activities.
- Equipment Development Engineer
- 2-year contract (client contract)
- Location : Tolochenaz
- Lead the development of specialized manufacturing equipment for medical device fabrication.
- Collaborate with cross-functional teams to define and develop User Requirement Specifications (URS) for new equipment.
- Partner with third-party manufacturers to oversee the design, production, and customization of equipment.
- Manage and conduct Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) to validate equipment functionality and compliance.
- Develop comprehensive validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Oversee equipment development projects from inception through completion, ensuring that milestones, timelines, and budgets are adhered to.
- Coordinate with suppliers, vendors, and internal stakeholders to ensure the timely delivery and successful integration of new equipment.
- Utilize project management tools to track progress, manage resources, and report on project status.
- Integrate automation solutions into manufacturing processes to enhance efficiency, accuracy, and scalability.
- Continuously identify and implement process improvements to optimize equipment performance and reduce costs.
- Stay informed about the latest advancements in automation technologies and manufacturing best practices.
- Maintain detailed and accurate documentation for all equipment development activities, including design modifications, validation reports, and compliance records.
- Ensure that all equipment and associated processes meet regulatory standards, including FDA, ISO 13485, and other applicable regulations.
Be flexible to travel up to 30% of the time to visit manufacturing sites, third-party vendors, and participate in on-site testing and validation activities.
- Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Automation Engineering, or a related field.
- Minimum of 5 years of experience in equipment development or manufacturing engineering within the medical device industry.
- Demonstrated experience with URS, FAT, and SAT processes.
- Strong understanding of automation systems, manufacturing processes, and equipment validation.
- Proficiency in project management tools and software.
- Skilled in CAD software (e.g., SolidWorks, AutoCAD) and other engineering design tools.
- Knowledge of regulatory requirements for medical device manufacturing (e.g., FDA, ISO 13485).
Does that sound interesting to you ? Then apply now !
À propos de l'entreprise
