Offer summary

Qualifications:

Minimum of 5 years of experience in a quality environment within the medical device industry., Bachelor’s degree in a relevant scientific, engineering, or related field., Certified software quality engineer (CSQE) or Certified Quality Engineer (CQE)., Strong analytical, organizational, and communication skills..

Key responsabilities:

Leading and providing guidance to the Hardware teams for new product development and sustaining engineering.

Representing the quality team on squads to support tactical work.

Oversight of contract manufacturing facilities, including quality agreements and periodic audits.

Improving processes for compliance and representing Beacon in audits and inspections.

Job description

Beacon Biosignals is on a mission to revolutionize precision medicine for the brain. We are the leading at-home EEG platform supporting clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our FDA 510(k)-cleared Dreem EEG headband and AI algorithms enable quantitative biomarker discovery and implementation. Beacon’s Clinico-EEG database contains EEG data from nearly 100,000 patients, and our cloud-native analytics platform powers large-scale RWD/RWE retrospective and predictive studies. Beacon Biosignals is changing the way that patients are treated for any disorder that affects brain physiology.

This role in the Quality department will be reporting to the VP of quality and has growth potential to a management position. The position will be located in the US, preferably in or near a Beacon hub. The role includes:

- Leading and providing guidance to the Hardware teams for new product development and sustaining engineering to support Beacon goals.

- Representing the quality team on squads to support tactical work

- Improving processes for compliance, implementing the least burdensome approach

- Representing Beacon in second and third party audits as well as inspections

- SME for hardware compliance processes across design, manufacturing, product release, and post market support

- Oversight of contract manufacturing facilities, including quality agreements, validation support, and periodic audits.

Beacon's robust asynchronous work practices ensure a first-class remote work experience, but we also have in-person office hubs available located in Boston, New York and Paris.

What success looks like

Supporting company goals and initiatives to ensure projects and products are completed on time, within scope, and in compliance with all applicable regulatory and company requirements.

What you will bring:

Minimum of 5 years of experience in a quality environment within the medical device industry

Proven ability to work autonomously with hands-on problem solving expertise and strong analytical skills

Certified software quality engineer (CSQE) or Certified Quality Engineer (CQE)

Working knowledge of key industry standards and regulations, including 21CFR 820, ISO 13485, and ISO 14971

Bachelor’s degree in a relevant scientific, engineering, or related field

A strong intellectual curiosity with the ability to quickly grasp complex concepts, and solve problems.

Exceptional interpersonal and relationship-building abilities

Strong analytical, organizational, and communication skills, with a demonstrated ability to adapt effectively to changing circumstances

The base salary range for this role is determined based on past experience, specific skills and qualifications. The base salary is one component of the total compensation package, which includes equity, PTO and other benefits.

At Beacon, we've found that cultural and scientific impact is driven most by those that lead by example. As such, we're always seeking new contributors whose work demonstrates an avid curiosity, a bias towards simplicity, an eye for composability, a self-service mindset, and - most of all - a deep empathy towards colleagues, stakeholders, users, and patients. We believe a diverse team builds more robust systems and achieves higher impact.

Required profile