Principal Engineer, Mechanical Engineering

Responsibilities

• Work independently with minimal supervision in engineering and product development environments.
• Work with industrial designers, system architects, marketing engineers, and customers to understand product requirements and best practices.
• Have experience with medical device construction techniques including printed circuit assembly, plastics and higher-level device assembly.
• Have knowledge of and the ability to leverage existing, medically proven state-of-the-art technologies when possible.
• Translate requirements into innovative, differentiated, and manufacturable design concepts in accordance with DFM practices.
• Lead mechanical design reviews, FMEAs, and technical trade-off discussions with stakeholders from other disciplines such as systems, electrical, packaging, reliability, and assembly engineering.
• Help secure design wins via the development of Minimum Viable Products (MVPs).
• Collaborate with ADI’s Global Operations organization to establish manufacturing guidelines and requirements to convert MVPs into commercial products.
• Apply a thorough understanding of verification and validation to demonstrate fulfillment of mechanical requirements.
• Ensure that task execution complies with product development requirements in a regulated sector.

Qualifications & Requirements

• Advanced degree in Mechanical, Electrical Engineering, or a related discipline.
• Minimum 10 years of experience in medical product development and an ability to demonstrate an understanding of how the mechanical aspects integrate with other disciplines such as biology, reliability, and electrical engineering.
• Demonstrated record of innovation, execution, and results, with high standards for performance.
• Mechanical design experience with a practical eye for manufacturing compatibility and cost effectiveness.
• Experience with medical-grade products involving mechanical components, materials, flexible substrates, and circuit card assemblies.
• Strong teamwork, inter-personal and communication skills coupled with a demonstrated ability to work at a high level of performance both independently and collaboratively.
• High levels of motivation and creativity, with an outgoing, positive attitude, and inquisitive nature.
• Extensive experience with SolidWorks and/or 3D CAD tools.
• Knowledge of circuit board stack-up and layout processes.

Desired

• 5+ years of project management experience.
• Knowledge of the FDA regulatory process and/or experience with an FDA approved medical device.
• Knowledge of regulatory requirements such as ISO 13485, IEC 60601, etc.
• Knowledge of assembly processes like surface-mount circuit board assembly and high-level product assembly (HLA).