Principal Engineer, Mechanical Design

Sonova AG•Santa Clarita, CA

2d•$131,560 - $164,450•Hybrid

About The Position

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.

Requirements

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%.

Nice To Haves

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.

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-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.