Manufacturing Engineer
We are Salvia: aninnovative startup active in the emerging field of bioelectronics. We derivedthe name Salvia from the Latin word salvere, which means to stayhealthy. In addition, the Salvia-herb has been used to treat headaches, pain,and mental disorders over centuries. Our mission is to deliver bioelectronicsolutions that restore health for people suffering from chronic migraine.Salvia is ambitious: we want to provide drug-free solutions that are effectiveand inherently side-effect free and make our novel solutions widely accessible.
We offer a challenging position for a ManufacturingEngineer with opportunities to grow with the organization. Working togetherwith Operations, R&D and Quality you will set-up new and maintain existing manufacturingprocesses for our innovative active implantable medical device, including thetooling 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 inline with regulatory requirements, including Equipment, Process & Productvalidations (IQ/OQ/PQ) and will drive process reliability and yieldoptimization from initial pilot production towards commercial scaling. You willassist with resolving issues e.g. arising from internal qualityassessments/audits, regulatory inspections, or post-market findings, and aid indriving closure of findings by contributing to CAPAs and preparing appropriateresponses. Whenever needed, you will provide day-to-day support to ourproduction and verification equipment. You enjoy working at the heart of amulti-disciplinary and dynamic start-up environment. Most importantly, you bringa can-do attitude and have a sharp eye for quality, partnering up with the teamto ensure timely realization of Salvia’s manufacturing line.
- Establish and maintain manufacturingdocumentation including, Equipment Documentation, pFMEA’s, Manufacturing WorkInstructions, Control Plans, Maintenance and Qualification routines.
- Provide engineering input toour cross-functional team, external development partners, and componentsuppliers.
- Characterize and evaluatecritical process parameters and support process development to enableproduction for clinical investigation initially, and support the scale-up tocommercial product builds.
- Support and train productionemployees, enabling them to efficiently execute product builds.
- Grow with the organization toenable Design Transfer to commercial-stage operational processes and provide continuedengineering leadership in scale-up phase.
- Minimum of 4 years ofexperience in medical device engineering and manufacturing.
- Strong technical expertise inthe setup, maintenance, and optimization of manufacturing processes andequipment design, with a background in Lean Manufacturing.
- Proficient in working withincleanroom environments (≤ Class 7). Prior experience in medical deviceassembly, including cleaning, silicone molding, and interconnect technologies,is a plus.
- Demonstrated ability toeffectively organize, prioritize, and manage multiple tasks simultaneously.
- Collaborative team player withexcellent technical, communication, and coordination skills.
- Bachelor’s degree inEngineering.
- Fluentin both English and Dutch, with strong written and verbal communication skills.
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Will you be our new colleague?
Our team is growing and we are always looking for passionate and talented individuals who want to be part of our mission to give people with migraine a better life.
We encourage open applications. Please submit yours here!
Acquisition is not appreciated.
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