We are hiring a Quality Engineer II to ensure the development, production, and delivery of the Company’s medical devices meet customer needs in accordance with the Company’s quality management system (QMS) and regulatory requirements. This hands-on position reports to the Quality Systems Manager and works closely with multifunctional team members, combining quality engineering expertise with document control and continuous improvement initiatives. All activities are performed within an FDA 21 CFR 820 and ISO 13485 compliant quality management system (QMS), alongside additional, relevant standards. An ambitious candidate with a track record of successful medical device compliance who wants to lead onsite quality activities and uphold rigorous standards of compliance and quality culture in a fast-growing startup would thrive in this role.

We are hiring a Manufacturing Manager to drive, manage, and fully execute the overall manufacturing effort for the Company’s medical devices with the objective of maximizing growth and meeting the device demand plan. This senior, hands-on position reports to the CEO and works closely with multifunctional team members, combining technology transfer and medical device manufacturing expertise with operations and leadership acumen to guide and execute timelines that drive products through production readiness and into the hands of customers. An ambitious candidate with a track record of successful manufacturing within controlled environments and operations leadership who wants to lead small teams, mentor junior members, and set the standard for medical device manufacturing in a fast-growing startup would thrive in this role.