Senior Quality Engineer (Design Assurance)

About the Company

At Presidio Medical, we are transforming the way neuromodulation balances the human nervous system and are striving to end the cycle of unnecessary pain and help patients live their best lives.

Presidio's Ultra Low Frequency (ULF™) Neuromodulation System blends innovative circuit design, computational modeling, material science advancements and expertise in neuroscience and electrochemistry. Our therapy is designed to target localized pain by reducing neuronal responses.3 Suppression of these signals may ease pain for some patients suffering from nociceptive pain.

Our focus is to break the cycle of constrained thinking about chronic nociceptive pain. Our goal is to create a world with less suffering — one that may offer relief to patients who have had limited therapeutic options.

Position Summary :

We are seeking an experienced and driven Senior / Staff Quality Engineer (Design Assurance) to play a key role in maintaining and enhancing our Quality Management System. This position is open to both Senior and Staff level candidates, offering a clear path for professional growth based on experience, technical depth, and leadership capabilities. You will ensure product quality and regulatory compliance by managing key processes from design through manufacturing.

Key Responsibilities :

• Design & Development Support : Partner with R&D to establish quality requirements and support design verification & validation (V&V), including testing for sterilization, packaging, and shelf-life.
• Risk Management : Maintain the Risk Management File in accordance with ISO 14971. Staff-level candidates will be expected to lead this process for assigned projects.
• Product & Process Control : Oversee quality activities for production, including incoming inspection, in-process testing, and final product release. Manage non-conforming product and lead investigations.
• Supplier Management : Qualify new suppliers, maintain the Approved Supplier List (ASL), and manage the Supplier Corrective Action Request (SCAR) program.
• Corrective Action : Lead the CAPA process from initiation through investigation, implementation, and verification of effectiveness.
• QMS & Audits : Support internal and external audits. Staff-level candidates will act as a Subject Matter Expert (SME) during audits and help lead continuous improvement initiatives for the QMS.
• Mentorship : Staff-level candidates will provide guidance and mentorship to junior quality engineers.
• Comply with Presidio Medical's quality system requirements as well as any applicable regulatory requirements.
• Comply with all health and safety regulations, policies, and work practices.
• Other duties as assigned.

Role Leveling :

Qualifications & Experience :

Physical Demands :

Range : $125,000 - $165,000.00

Note :

This role is not sponsorship eligible.

This role is based in San Mateo, CA

Presidio Medical is not engaging with staffing agencies at this time