Director of Engineering
2 weeks ago
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
- Bachelor’s 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
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