Principal Engineer, Mechanical Design

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.