Principal Engineer, Mechanical Design

Valencia, California | Hybrid

Join Advanced Bionics, a Sonova Group company, as a Principal Mechanical Engineer and help develop innovative cochlear implant systems and body-worn medical devices that improve the lives of people with hearing loss.

In this role, you will provide technical leadership throughout the mechanical product-development lifecycle-from requirements and concept development through prototyping, verification, validation, manufacturing and market introduction. You will also mentor less-experienced engineers and collaborate with multidisciplinary teams, suppliers, consultants and members of the medical community.

Responsibilities

• Lead the mechanical design and development of external and implantable systems and their associated components.

• Develop products from initial concept through prototyping, manufacturing and commercial introduction.

• Establish product requirements, technical specifications and mechanical design solutions.

• Create and maintain 3D CAD models, engineering drawings, tolerance-stack analyses, design specifications and technical reports.

• Apply design-for-manufacturing principles and structured product-development methodologies.

• Lead make-versus-buy and fabrication decisions in collaboration with internal teams and external suppliers.

• Ensure designs comply with functional requirements, internal procedures, quality-system requirements, industry standards and regulatory expectations.

• Plan and support design-of-experiments, component testing, product testing and verification and validation activities.

• Lead mechanical failure investigations and support root-cause analysis and corrective actions.

• Support sustaining-engineering activities throughout the product lifecycle.

• Establish 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 on technical requirements, component development, tooling and manufacturing readiness.

• Work with consultants, vendors and members of the medical and cochlear implant communities.

• Provide technical guidance regarding technology partnerships, supplier relationships and intellectual property.

• Plan, coordinate and execute engineering activities in support of project objectives.

• Build and maintain knowledge of evolving clinical needs, product use cases and market requirements.

• Mentor and coach engineers while providing cross-functional technical leadership within a core-team environment.

• Perform other duties and responsibilities as assigned.

Qualifications

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

• Eight or more years of mechanical or microelectronic product-development experience.

• Experience developing complex electromechanical products from concept through production.

• Experience designing miniature mechanical components, plastic and metal enclosures, microelectronic packages, connectors, cables, antennas, electrical contacts or switches.

• Knowledge of plastic-part design, injection molding, materials selection and manufacturing processes.

• Knowledge of conductors, polymers, silicone, adhesives, coatings and biocompatibility requirements.

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

• Working knowledge of verification and validation, design controls and Design History File requirements.

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

• Demonstrated ability to lead technical work and mentor junior engineers.

• Strong communication, organization, collaboration and presentation skills.

• Ability to manage multiple priorities and meet project deadlines in a cross-functional environment.

• 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 $131,560-$164,450 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.