About us 

Salvia BioElectronics is a medical device company pioneering neuromodulation therapies for migraine. Salvia's unique, paper-thin implant is designed to reduce the frequency and intensity of migraine attacks by delivering gentle electrical pulses to the nerves associated with the condition. The company is currently in the clinical stage of development. In addition, Salvia is considering potential opportunities the device creates for the treatment of cluster headache and other neurological disorders. Salvia has received the Breakthrough Device Designation from the United States Food and Drug Administration (FDA), which facilitates expedited market access for devices that treat life-threatening or irreversibly debilitating conditions. 

The challenge  

We offer a challenging position for a Senior Process Development Engineer in our R&D department. Working together with Quality and Operations you will validate our manufacturing processes for our innovative active implantable medical device. You will develop and execute required validations in line with regulatory requirements, including Equipment, Process & Product validations (IQ/OQ/PQ). You enjoy working at the heart of a multi-disciplinary and dynamic scale-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 master validation plans for in-house production, including, control plans, gauge R&R, test method validations, process flows, maintenance and qualification routines.  
• Collaborate with the external manufacturing partners in validating the supply chain. 
• Enable Design Transfer to commercial-stage operational processes and provide continued engineering leadership in scale-up phase. 

YOUR PROFILE 

• 5 years medical device engineering / manufacturing experience.  
• Strong technical understanding of validation of manufacturing processes. Experience with statistical methods is highly desirable.  
• Prior experience in medical device assembly including cleaning, silicone molding, interconnect  technologies and lean manufacturing, is considered an advantage.  
• MSc or BSc degree in engineering.