Principal Mechanical Engineer, Medical Devices (Hybrid)

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

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.