Senior Engineer, Mechanical

Sonova Group; Santa Clarita (CA); Hybrid; USD 100,000 - 125,000; Full time

Job summary

Advanced Bionics, a Sonova Group company, invites applications for a Senior Mechanical Engineer in Valencia, CA. Join a team developing cochlear implant systems and body-worn devices, driving mechanical development through all lifecycle stages.

You will design and verify electromechanical components, work with cross-functional teams, and ensure regulatory compliance while mentoring junior engineers. Hybrid work model with travel ~15% may apply.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or related.
• Five+ years of mechanical or microelectronic product-development experience.
• Experience developing electromechanical products from concept through manufacturing.
• Experience designing miniature components, enclosures, connectors or switches.
• Knowledge of plastic-part design and manufacturing processes.
• Knowledge of conductors, polymers and biocompatibility requirements.
• Experience creating 3D CAD models, drawings and tolerance analyses.
• Knowledge of verification/validation, design controls and documentation.
• Strong communication, organization and teamwork skills.
• Travel approximately 15%.

Responsibilities

• Design and develop external and implantable systems and their mechanical components.
• Support products from concept to prototyping, manufacturing and market launch.
• Establish mechanical requirements with cross-functional teams.
• Create and maintain 3D CAD models, drawings and tolerances.
• Apply design-for-manufacturing principles and product development methods.
• Participate in make-versus-buy and fabrication decisions.
• Ensure designs meet functional, quality and regulatory requirements.
• Develop DOE, component tests and product verification activities.
• Conduct root-cause analysis for mechanical failures and support actions.
• Support sustaining-engineering for existing products.
• Prepare Design History File and participate in design reviews.
• Ensure FDA/ISO design controls compliance and documentation.
• Collaborate with suppliers on technical requirements and tooling.
• Work with consultants, vendors and medical community.
• Plan, coordinate and execute engineering tasks to meet objectives.
• Learn evolving clinical requirements and product-use cases.
• Collaborate within multidisciplinary core teams; mentor junior engineers.
• Perform other duties as assigned.

Skills

Analytical

Communication

Teamwork

Problem-solving

Education

Bachelor's in Mechanical or Biomedical Eng

Master's degree (preferred)

Tools

Creo/ProE

SolidWorks

PLM/PDM

MS Office 365

Job description

Valencia, California | Hybrid
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.