Valencia, California | Hybrid
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.
