Principal Engineer, Mechanical Design

Sonova Group; Santa Clarita (CA); Hybrid; USD 132,000 - 164,000; Full time

Job summary

Advanced Bionics, a Sonova Group company in Valencia, CA, is seeking a Principal Mechanical Engineer to lead the mechanical design of external and implantable systems. You will guide projects through conceptualization, prototyping, verification and manufacturing, while mentoring engineers and coordinating with suppliers and medical stakeholders.

You will drive requirements, create CAD models and drawings, and ensure outputs meet FDA/ISO design controls and quality standards.

Qualifications

• Bachelor's degree in Mechanical/Biomedical engineering or related field.
• Eight+ years of mechanical or microelectronic product-development experience.
• Experience developing complex electromechanical products from concept through production.
• Experience designing miniature mechanical components and enclosures.
• Knowledge of plastic-part design, injection molding and manufacturing processes.
• Knowledge of biocompatibility requirements.
• Experience creating 3D CAD models and engineering drawings.
• Familiarity with verification/validation and Design History File requirements.
• Strong analytical and problem-solving skills.
• Ability to lead and mentor junior engineers.

Responsibilities

• Lead mechanical design and development of external and implantable systems.
• Develop products from concept through prototyping and manufacturing.
• Establish product requirements and mechanical design specifications.
• Create and maintain 3D CAD models, drawings and reports.
• Apply design-for-manufacturing principles and product-development methodologies.
• Lead make-versus-buy decisions with internal teams and suppliers.
• Ensure designs meet regulatory and quality-system requirements.
• Plan and support design-of-experiments and validation activities.
• Lead failure investigations and corrective actions.
• Support sustaining engineering and design reviews.
• Ensure FDA/ISO design controls compliance.
• Collaborate with suppliers and vendors for development and manufacturing readiness.

Skills

Leadership

Mentor engineers

Cross-functional collaboration

Problem solving

Communication

Education

Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related

Master's degree in Mechanical/Biomedical Engineering (preferred)

Tools

ProEngineer/Creo

SolidWorks

PLM/PDM systems

MS Office 365

MS Project

Moldflow

ANSYS

Minitab

Job description

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.

Sonova is an equal opportunity employer.

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.