Head of Systems Engineering - medical device start-up

InnoTECH Staffing is looking to hire a Head of Engineering for an exciting and growing medical device start-up in the Boston, MA area.

We are looking for a Head of Engineering for the Back Bay Boston, MA office. In this role, you will lead engineering and systems integration efforts across the business, taking the prototype device into clinical manufacturing and through commercialization.

The ideal candidate must have the following:
BS degree in Engineering
Min of 7 years in medical device
Min of 3 years of prior management experience
Experience with neuro stimulator OR active implants
Experience taking a medical device through to Clinical but Commercialization is ideal
Experience should be Hardware focused, not software focused
Experience with integration - hardware, firmware, and software
Experience with FDA quality systems and Design History Files
Experience working with manufacturing partners
Must be an Individual Contributor who can roll up their sleeves
Will have direct reports as they grow
Will oversee testing at company and contract manufacturing house
Ideally the person will oversee all of Engineering - not just Systems
​​​​​
RESPONSIBILITIES

• Plan, evaluate, and develop the Company’s medical device products.
• Assess existing system architecture and recommend improvements.
• Direct the integration of all technical aspects of the device, including hardware, firmware, and software.
• Define the scope of design verification and automated testing, and provide key support for verification and validation activities.
• Maintain Design History File (DHF) documentation and support regulatory submissions.
• Maintain risk register and oversee risk reduction.
• Ensure devices conform to established requirements and specifications and are built following validated processes to meet customer needs.
• Lead manufacturing improvement activities and manage supplier relations.
• Drive system-wide troubleshooting and root cause analysis investigation across the Company.
• Develop strategies to monitor device reliability and performance in the field.
• Mentor other engineers in technical and professional development.

• Bachelor’s degree in engineering or related field.

• Minimum 7 years of progressive experience in medical device industry (Class II or III).
• Minimum 3 years of prior management experience.

• Demonstrated experience with FDA Quality Systems Regulations and ISO 13485; experience with neurostimulator device development (ISO-14708) preferred.
• Strong leadership skills with demonstrated ability to create momentum and deliver business results.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Proven project management skills; highly developed problem-solving skills.
• Ability to multi-task, prioritize, meet deadlines, and hold others accountable.
• Understanding of mechanical, electronic, and software design principles.
• Knowledge of electronics assembly required; familiarity with test systems a plus.
• Ability to take designs from prototype through clinical manufacturing.
• Ability to travel domestically.

Keywords:
Neuromodulation
Neurostimulator or neuro stimulator
Neural stimulation
Neurostimulation or neuro stimulation
Brain stimulation / brain stimulator
Brain Therapies / Brain therapy
Brain injury