Senior Engineer, Mechanical

Sonova USA Inc.; California (MO); Hybrid; USD 100,000 - 125,000; Full time

Job summary

Advanced Bionics, a Sonova Group company, is seeking a Senior Mechanical Engineer to contribute to developing cochlear implant systems and body-worn medical devices that improve hearing.

You will support mechanical product-development across the lifecycle, including requirements, design, prototyping, testing, verification, validation and sustaining engineering with FDA/ISO design controls. Collaborate with suppliers and cross-functional teams to deliver robust solutions.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related field.
• Five+ years in mechanical or microelectronic product development.
• Experience from concept to manufacturing for electromechanical products.
• Experience designing miniature components, enclosures, connectors or sensors.
• Knowledge of plastic-part design, molding and manufacturing processes.
• Familiarity with design controls, FDA/ISO documentation and validation.

Responsibilities

• Design external and implantable mechanical components and systems.
• Support product development from concept through manufacturing and market introduction.
• Establish mechanical requirements and specifications with cross-functional teams.
• Create and maintain 3D CAD models, drawings, tolerances and reports.
• Apply design-for-manufacturing principles and DFMEAs.
• Plan and execute DOE, testing, verification and validation activities.
• Conduct failure investigations and support root-cause analysis.
• Collaborate with suppliers, vendors and medical community.
• Maintain Design History File documentation and participate in design reviews.

Skills

Analytical thinking

Problem solving

Teamwork

Communication

Cross-functional collaboration

Education

Bachelor's in Mechanical Engineering

Master's in Mechanical/Biomedical Engineering

Tools

CAD software (Pro/Creo/SolidWorks)

PLM/PDM systems

MS Project

Job description

Who we are

At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear implants. We're dedicated to providing outstanding customer experiences through our global audiological care services, ensuring that everyone has the opportunity to engage fully with the world around them.

Guided by a culture of continuous improvement that fosters resilience and self-motivation, our team is united by a shared commitment to excellence and a deep sense of pride in our work, each of us playing a vital role in creating meaningful change,

Here you'll find a diverse range of opportunities that span both consumer and medical solutions and the freedom to shape your career while making an impact on the lives of others. Join us in our mission to create a more connected world, where every voice is heard and every story matters.

Valencia (CA), United States

Valencia, California | Hybrid

Senior Engineer, Mechanical

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.

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.