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.

• Experience 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%.

Preferred Qualifications

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

• Medical-device product-development experience.

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

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

• Experience designing tooling and fixtures.

• Experience using MS Project, Moldflow, ANSYS or Minitab.

Compensation

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.