Principal Engineer, Mechanical Design
- Compensation
- Not disclosed
- Location
- Not listed
- Work setup
- Not specified
- Seniority
- Principal
- Employment
- Not specified
- Experience
- Not specified
- Category
- Design
- Posted
Skills
Must have
- 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 have
- 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.
Full 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
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Lead the mechanical design and development of external and implantable systems and their associated components.
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Develop products from initial concept through prototyping, manufacturing and commercial introduction.
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Establish product requirements, technical specifications and mechanical design solutions.
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Create and maintain 3D CAD models, engineering drawings, tolerance-stack analyses, design specifications and technical reports.
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Apply design-for-manufacturing principles and structured product-development methodologies.
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Lead make-versus-buy and fabrication decisions in collaboration with internal teams and external suppliers.
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Ensure designs comply with functional requirements, internal procedures, quality-system requirements, industry standards and regulatory expectations.
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Plan and support design-of-experiments, component testing, product testing and verification and validation activities.
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Lead mechanical failure investigations and support root-cause analysis and corrective actions.
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Support sustaining-engineering activities throughout the product lifecycle.
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Establish and maintain Design History File documentation and participate in formal design reviews.
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Ensure compliance with FDA and ISO design controls and documentation requirements.
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Collaborate with suppliers on technical requirements, component development, tooling and manufacturing readiness.
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Work with consultants, vendors and members of the medical and cochlear implant communities.
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Provide technical guidance regarding technology partnerships, supplier relationships and intellectual property.