Manufacturing Process Engineer - MN

Company Overview

Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting-edge technologies that restore autonomy to people living with disabilities and improve their quality of life.

Join a small, dedicated team of knowledgeable and motivated professionals. Our early-stage environment offers the opportunity to take ownership of broad decisions with significant and long-lasting impact. We emphasize continuous learning and growth, fostering cross-functional collaboration where your contributions are vital to our success.

We are seeking aSenior Manufacturing Process Engineer to support a wide array of technologies and suppliers engaged in realizing the Echo Active Implantable BCI (Brain Computer Interface) device for enabling communication in patients with significant disabilities.

You will be responsible for developing manufacturing processes, tooling, documentation, from development through validation, into clinical studies, and ultimately commercial release, in conjunction with suppliers domestically and internationally.

This role will rely on hands-on interaction with suppliers as well as the Echo engineering teams, understanding the design intent and ensuring that it is realized in a device that is safe and effective. This individual will have primary responsibility for continuous improvement, including process and documentation, as well as responding to events that impact our ability to meet product quality, schedule, and cost objectives.

Echo Neurotechnologies is committed to using 3rd party resources to manufacture and in some cases develop our product. Real time engagement and technical support of these suppliers is key to this strategy. The ability to maintain excellent working relationships with an array of technically and geographically diverse suppliers is critical to our success.

• Primary contact for technical support to Ensure Echo’s suppliers succeed in delivering products and services critical to Echo’s success.
• Provide input and collaborative support to the product development process ensuring that design outputs are well defined, manufacturable, and consistent with medical device quality system requirements.
• Work with suppliers and Echo’s development team to ensure that suppliers appropriately implement specifications for components, assemblies, and finished devices consistent with design intent and quality system requirements.
• Develop documentation that accurately maps Echo’s designs into supplier’s processes.
• Participate in risk management activities including Process FMEAs, Validation, and failure analysis.
• Continuously improve supply chain related processes with an eye toward adding value & improving efficiency.
• Maintain a goal oriented, collaborative & productive work environment.
• Ensure product is manufactured in compliance with Echo’s quality system, FDA and EU Requirements. Reconcile any conflicts between Echo’s quality system and suppliers.
• Provide technical support to resolve non-conformance and corrective actions with suppliers.

• B.S. in relevant engineering discipline, or equivalent experience.
• 10 or more years of medical device manufacturing experience, preferably in senior roles at start-up companies developing and manufacturing electro-mechanical devices.
• Experience with active implantable systems (Implant, Leads, Externals, etc.).
• Experience with medical device manufacturing including molding, laser welding, clean room assembly, packaging, labeling, and sterilization.
• Experience with electronic manufacturing and test including PCB fab, PCA assembly, microelectronics assembly, flip chip, in circuit test (ICT) and functional test.
• Experience with manufacturing automation.
• Experience in defining and executing process validation activities.
• Experience collaborating with internal customers and external partners.
• Understanding of and experience implementing validating manufacturing processes for medical devices in accordance with FDA and EU Requirements.
• Experience with Solidworks,…