Director of Engineering - Military veterans preferred

CM Medical have partned with a neurostimulation start-up that is seeking a Director of Engineering for their Boston, MA office.

This role involves leading engineering efforts, guiding their prototype device into clinical manufacturing.

Responsibilities:

• Provide mentorship to engineers in technical and professional growth.
• Strategise, assess, and advance our medical device products.
• Evaluate system architecture and propose enhancements.
• Oversee integration of all technical aspects, including hardware, firmware, and software.
• Define design verification scope and automated testing, supporting verification and validation.
• Manage Design History File (DHF) documentation and regulatory submissions.
• Supervise risk register and lead risk mitigation efforts.
• Ensure device adherence to requirements and specifications, employing validated processes.
• Lead manufacturing enhancement initiatives and maintain supplier relationships.
• Drive system-wide troubleshooting and root cause analysis.
• Devise strategies for monitoring device reliability and performance.

Experience

• Bachelors degree in engineering or related field.
• Experience in medical device industry (Class III).
• Familiarity with FDA Quality Systems Regulations and ISO 13485; exposure to ISO-14708 is advantageous.
• Strong leadership abilities, excellent communication skills, and adept problem-solving capabilities.
• Ability to manage multiple tasks, meet deadlines, and enforce accountability.
• Understanding of mechanical, electronic, and software design principles.
• Proficiency in navigating designs from prototype to clinical manufacturing.

How do I apply?

If you like what you've read so far, hit the apply button or send your CV to ryan.tosh@medical-cm.com