Job Details

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 Software Quality Engineer 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:

• At the Senior Level, you are a proven, hands-on engineer who reliably executes and manages core quality subsystems with minimal supervision.
• At the Staff Level, you are a technical leader and subject matter expert who tackles more complex projects, leads risk management activities, mentors others, and represents the quality function as an audit SME.

Qualifications & Experience:

• Bachelor's degree in Engineering or a related scientific field.
• 5+ years of quality engineering experience in the medical device industry for Senior level.
• 8+ years of progressive quality engineering experience for Staff level.
• Required for All Levels: Proven hands-on experience with design controls and a strong working knowledge of FDA 21 CFR 820, ISO 13485, and ISO 14971.
• ISO 13485 Lead Auditor certification is a plus.
• Strongly Preferred for Staff Level:
• Demonstrated expertise in developing and maintaining Risk Management Files.
• Experience with software V&V (SaMD experience is a plus).
• Proven experience as a subject matter expert during external regulatory audits.
• The final salary offered will be determined based on the candidate's professional experience, qualifications, and geographic location.

Physical Demands:

• Varied sitting, standing, and walking.
• Ability to lift and carry 50lbs. or less.

Note:

This role is not sponsorship eligible.

• This role is hybrid, based in San Mateo, CA

Pay range is $125,000-$165,000.00

Equal Opportunity Statement

We are committed to diversity and inclusivity.

***Presidio Medical is not engaging with staffing agencies at this time***