huMannity Medtec

The successful candidate will work closely with R&D, Manufacturing, and Quality Assurance to develop and verify Class III medical devices for clinical studies. Review and approve engineering and production documents to ensure compliance with design control requirements. Support pilot manufacturing and design verification activities. Must have a good working knowledge of CFR 820, ISO 14971 and ISO 13485. Main responsibilities: • Represent Quality Assurance on product development teams. • Participate in design reviews and technical meetings. • Review and approve Engineering Change Orders. • Provide Quality Engineering input to Manufacturing teams and support manufacturing/QC activities. • Assist with transfer of design to pilot production. • Drive non conformances to closure through root cause analysis and CAPA. • Support risk analysis, design assurance, and verification activities for Class III products. • Support cleanroom and sterilization processes. • Support quality system...

Position summary: The successful candidate will work closely with R&D, Manufacturing, and Quality Assurance to support product development and production efforts for all aspects of implantable medical devices and systems; research, plans and designs for mechanical and electromechanical products and systems; coordinates activities involved in fabrication, operation, application, installation, and repair of same. Main responsibilities: Confers with planning and design staff concerning product design and tooling to ensure efficient production methods. Specifies, designs, analyzes, simulates, prototypes, builds, tests, documents and releases to manufacturing parts, processes, procedures, assemblies, materials, tooling/fixtures and equipment. Organizes, plans, tracks, and closes out design and process issues associated with product performance in development, test, manufacturing, and the field. Designs and documents processes and/or tooling/fixtures and equipment such as...

At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow's challenges. If you'd like to join a high-reward, truly inspiring environment with an experienced, diverse team working at their best every day, and take your career to the next level, apply today! We truly understand the need for balance and, among other things and offer a 9/80 schedule with every other Friday off. That's 26 long weekends a year! Summary: As a key member of the EE team, this Principal Electrical Engineer will participate in all phases of the product development of medical devices from early concept through qualification, field test, and clinical use. This role will research, develop, design, prototype, and test electrical components, circuits, equipment, and systems that support active medical implant technology. Apply engineering...