Senior Engineer, Mechanical (Valencia (CA), United States)

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.

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.

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or a related engineering discipline.

Five or more years of mechanical or microelectronic product-development experience.

developing electromechanical products from concept through manufacturing.

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.

creating 3D CAD models, engineering drawings and tolerance analyses.

Knowledge of product verification and validation, design controls and technical documentation.

Strong analytical, problem-solving and mechanical failure-analysis skills.

Strong communication, organization, teamwork and presentation skills.

Ability to coordinate across departments, manage priorities and meet project deadlines.

Proficiency with Microsoft Office 365, PLM/PDM systems and ProEngineer/Creo or comparable CAD software, such as SolidWorks.

Ability to travel approximately 15%.

Master’s degree in Mechanical Engineering, Biomedical Engineering or a related field.

Medical-device product-development experience.

with cochlear implants, hearing aids, wearable technology or consumer audio products.

with finite element analysis, statistical analysis and Failure Mode and Effects Analysis.

designing tooling and fixtures.

using MS Project, Moldflow, ANSYS or Minitab.

The target base salary range for this position is $100,320–$125,400 annually.

A career at Advanced Bionics offers an opportunity to work with innovative technology and collaborate with talented colleagues who share a commitment to helping people experience the joy of hearing.