About us

We are Salvia: an innovative startup active in the emerging field of bioelectronics. We derived the name Salvia from the Latin word salvere, which means to stay healthy. In addition, the Salvia-herb has been used to treat headaches, pain, and mental disorders over centuries. Our mission is to deliver bioelectronic solutions that restore health for people suffering from chronic migraine. Salvia is ambitious: we want to provide drug-free solutions that are effective and inherently side-effect free and make our novel solutions widely accessible.

The challenge

We offer a challenging position for a Manufacturing Engineer with opportunities to grow with the organization. Working together with Operations, R&D and Quality you will set-up new and maintain existing manufacturing processes for our innovative active implantable medical device, including the tooling and equipment required. You are responsible for the design, procurement, and realization of Salvia’s production and verification equipment. You will execute, supported by process engineering, required validations in line with regulatory requirements, including Equipment, Process & Product validations (IQ/OQ/PQ) and will drive process reliability and yield optimization from initial pilot production towards commercial scaling. You will assist with resolving issues e.g. arising from internal quality assessments/audits, regulatory inspections, or post-market findings, and aid in driving closure of findings by contributing to CAPAs and preparing appropriate responses. Whenever needed, you will provide day-to-day support to our production and verification equipment. You enjoy working at the heart of a multi-disciplinary and dynamic start-up environment. Most importantly, you bring a can-do attitude and have a sharp eye for quality, partnering up with the team to ensure timely realization of Salvia’s manufacturing line.

Responsibilities

· Establish and maintain manufacturing documentation including, Equipment Documentation, pFMEA’s, Manufacturing Work Instructions, Control Plans, Maintenance and Qualification routines.

· Provide engineering input to our cross-functional team, external development partners, and component suppliers.

· Characterize and evaluate critical process parameters and support process development to enable production for clinical investigation initially, and support the scale-up to commercial product builds.

· Support and train production employees, enabling them to efficiently execute product builds.

· Grow with the organization to enable Design Transfer to commercial-stage operational processes and provide continued engineering leadership in scale-up phase.

YOUR PROFILE

· Minimum of 4 years of experience in medical device engineering and manufacturing.

· Strong technical expertise in the setup, maintenance, and optimization of manufacturing processes and equipment design, with a background in Lean Manufacturing.

· Proficient in working within cleanroom environments (≤ Class 7). Prior experience in medical device assembly, including cleaning, silicone molding, and interconnect technologies, is a plus.

· Demonstrated ability to effectively organize, prioritize, and manage multiple tasks simultaneously.

· Collaborative team player with excellent technical, communication, and coordination skills.

· Bachelor’s degree in Engineering.

· Fluent in both English and Dutch, with strong written and verbal communication skills.Contact

mb.info@salvianeuro.com