Senior Engineer, Mechanical

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.