Senior Quality Engineer

Quality & Regulatory                ·              Brooklyn, New York, United States               ·             Full time

Senior Quality Engineer

Brooklyn, New York, United States

About Synchron 

Synchron is a clinical-stage endovascular brain computer interface (BCI) company. Since 2012, the company has been developing a BCI platform that avoids the need for open brain surgery by using a minimally-invasive procedure. The Synchron Switch™ BCI received FDA Breakthrough Device Designation in 2020, and is currently in human clinical trials in the US and Australia.

The company recently announced an oversubscribed $75 million Series C financing round led by ARCH Venture Partners, with participation from Gates Frontier, Bezos Expeditions and other top-tier investors. The funds will accelerate product development, facilitate commencement of a pivotal clinical trial, and advance Synchron towards a first-in-class BCI market approval for the treatment of paralysis.

The Synchron Switch™ brain computer interface is implanted in the blood vessel on the surface of the motor cortex of the brain via the jugular vein, through a minimally-invasive endovascular procedure. Once implanted, it is designed to detect and wirelessly transmit motor intent out of the brain, restoring a capability for severely paralyzed patients to control personal devices with hands-free point-and-click. Synchron is a dynamic, multi-disciplinary and rapidly growing team.

Join our mission of developing a first-in-class commercial BCI for more than 100 million people worldwide with upper limb impairment. Help people with previously untreatable conditions regain connection to the world.

Senior Quality Engineer

We are a lean, fast-paced, passionate team pushing the boundaries of what is possible in the neurotech and brain-computer interface space to dramatically improve quality of life of millions of people globally. 

As Senior Quality Engineer, you will be responsible for Quality System activities ranging from process development through engineering and transfer to manufacturing and beyond. Your work will be instrumental to meeting customer and regulatory requirements. You will provide focused, hands-on, quality engineering support throughout all stages of product development, apply diversified knowledge of engineering, verification, validation, supplier management and quality principles and practices for implantable medical devices and accessories.  Your quality support will focus around software engineering and software design controls including but not limited to, software and cybersecurity risk management, software usability and non-product software validation activities. It will also be part of your role to maintain and enhance a culture of quality, setting the expectation within the company and for our suppliers that we do things right for our patients.

A successful candidate for this role will be motivated and able to work independently, with little guidance from leadership.  

Responsibilities  

• Responsible for execution of quality processes and quality systems application within the department and across departments.
• Transfer design to manufacturing and provide feedback and oversight to suppliers to ensure robust quality systems and product
• Drive design improvement, nonconformance and corrective action processes internally and with suppliers
• Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues internally and with suppliers
• Provide documentation and respond to requests in internal and external quality inspections
• Lead activities for Risk Management, including development of critical documentation in compliance with Synchron’s procedures and external standards
• Assist in developing software manufacturing documentation such as software bill of materials, and software maintenance and release activities

Minimum Qualifications  

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Software Engineering or other relevant technical or science field
• 5+ years of experience working with a quality system for FDA-regulated (or equivalent) class 2 or 3 medical devices.

Skills and Knowledge  

• In-depth knowledge of Design Controls, Quality System Management, Software Systems, Software and Cybersecurity Risk Management, Systems Engineering, and Usability Engineering.
• Have working knowledge of applicable design standards (e.g. IEC 60601-1, IEC 62304, EN ISO 14971, IEC 62366-1, IEC 62366-2, TIR57, IEC TR 80002-1)
• Understanding of Quality Systems and applicable GMP regulations and standards (e.g., ISO 13485, QSR 21 CFR Part 820)
• Knowledge of Document Control standards, practices, and principles
• Highly developed written and oral communication skills and ability to work in a team environment
• Possesses initiative and is proactive
• Excellent organizational, time management, and planning skills
• Demonstrated attention to detail and ability to prioritize among multiple projects
• Ability to travel up to 20% of time

Preferred Qualifications  

• Experience in clinical studies (in particular IDE and PMA)
• Lead auditor certification with 3+ years auditing experience in an FDA regulated Class 2 or 3 medical device environment to QSR 21 CFR Part 820 and ISO 13485 quality systems.
• Practical application of statistical concepts including SPC techniques, hypothesis testing, DOE, and sampling plans
• Experience with class III medical devices in an area such as neuromodulation, vascular devices or cardiac rhythm management
• Experience participating in quality inspections

Expected annual salary range: $125K-$140K

At Synchron, we value our culture and the way we work together to achieve our goals. You will be among a group of hard-working, fun and caring people who support each other and are passionate about bringing life-changing technologies to people.

Synchron provides equal employment opportunities to all employees and applicants for employment, and prohibits discrimination and harassment of any type without regard to race, ethnicity, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. 

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