Valencia, California | Hybrid
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.
