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

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

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

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Establish product requirements, technical specifications and mechanical design solutions.

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

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

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

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

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

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

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Support sustaining-engineering activities throughout the product lifecycle.

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Establish and maintain Design History File documentation and participate in formal design reviews.

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Ensure compliance with FDA and ISO design controls and documentation requirements.

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Collaborate with suppliers on technical requirements, component development, tooling and manufacturing readiness.

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

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

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

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

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

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Perform other duties and responsibilities as assigned.

Qualifications

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

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

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Experience developing complex electromechanical products from concept through production.

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

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

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

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

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

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

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Demonstrated ability to lead technical work and mentor junior engineers.

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Strong communication, organization, collaboration and presentation skills.

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

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

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Ability to travel approximately 15%.

Preferred Qualifications

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

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Medical-device product-development experience.

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

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

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Experience designing tooling and fixtures.

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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.