Senior Engineer, Mechanical

Valencia, California | Hybrid Join Advanced Bionics, a Sonova Group company, as a Senior Mechanical Engineer and contribute to the development of innovative cochlear implant systems and body-worn medical devices that improve the lives of people with hearing loss. In this role, you will support mechanical product-development activities throughout the complete lifecycle, including requirements development, design, prototyping, fabrication decisions, testing, verification, validation, failure analysis and sustaining engineering. Responsibilities Design and develop external and implantable systems and their associated mechanical components. Support products from concept development through prototyping, manufacturing and market introduction. Establish mechanical requirements and specifications in partnership with cross-functional teams. Create and maintain 3D CAD models, engineering drawings, tolerance-stack analyses, design specifications and technical reports. Apply design-for-manufacturing principles and established product-development methodologies. Participate in make-versus-buy and fabrication decisions. Ensure designs comply with functional requirements, internal procedures, quality-system requirements, industry standards and regulatory expectations. Develop and execute design-of-experiments, component testing, product testing and verification and validation activities. Conduct mechanical failure investigations and support root-cause analysis and corrective actions. Support sustaining-engineering activities for existing products. Prepare and maintain Design History File documentation and participate in formal design reviews. Ensure compliance with FDA and ISO design controls and documentation requirements. Collaborate with suppliers regarding technical requirements, component development, tooling and manufacturing processes. Work with consultants, vendors and members of the medical community. Plan, coordinate and execute engineering assignments in support of project objectives. Build knowledge of evolving clinical requirements, customer needs and product-use cases. Collaborate effectively within multidisciplinary core teams. Assist and mentor less-experienced engineering team members. Perform other duties and responsibilities as assigned. Qualifications Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or a related engineering discipline. Five or more years of mechanical or microelectronic product-development experience. Experience developing electromechanical products from concept through manufacturing. Experience designing miniature components, plastic and metal enclosures, microelectronic packages, connectors, cables, antennas, electrical contacts or switches. Knowledge of plastic-part design, injection molding and manufacturing processes. Knowledge of conductors, polymers, silicone, adhesives, coatings and biocompatibility requirements.…