Full-Time
Staff NPI Engineer
Posted on 3/5/2025
Mendaera
51-200 employees
Delivers point-of-care medical devices
Compensation Overview
$168k - $211k/yr
San Mateo, CA, USA
In Person
 Mechanical Engineering (2) |
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- Lead the design transfer of the capital equipment product lines, including setting up and optimizing the manufacturing lines
- Lead DFM/DFA activities, working closely with the R&D engineers, Operations and suppliers to ensure the components can be manufactured at the highest quality and lowest cost possible
- Enhance the internal manufacturing process by improving the assembly fixture designs and documentation (MPI and Traveler/LHR) to maximize the line capacity, throughput and highest first pass yield
- Lead the pFMEA analysis, equipment and process qualifications activities, including writing protocols and reports
- Perform root cause analysis and implement corrective actions to mitigate and prevent field issues/escapes
- Collaborate with suppliers to implement process control plans and resolve quality issues
- Work cross functionally to support supplier audits and component sourcing
- Lead process capability analysis (Cpk) to identify improvements in the processes
- May require some travel to visit suppliers and CMs
- BS or MS in mechanical engineering, manufacturing engineering or equivalent discipline
- 8 years experience in industry or equivalent
- Experience manufacturing complex, tight tolerance designs in the medical device or similarly regulated industry.
- Experience designing and fabricating assembly fixtures
- Manufacturing process expertise including cable assembly, molding, machining and stamping
- Expertise performing process characterization/ development, IQ/OQ/PQs, and pFMEA.
- Extensive experience with root cause analysis and problem solving for both technical and process issues.
- Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003 or ISO9001and EN46001.
- Working knowledge of CAD (Solidworks or other) software.
- PCBA process experience is a plus
Mendaera provides medical devices and healthcare technology designed to support clinicians at the point of care. Its solutions help doctors and nurses perform procedures with higher precision and consistency directly where patients receive treatment, aiming to streamline care and improve outcomes. The devices integrate into the care workflow to reduce unnecessary patient movement, speed recovery, and lower overall costs. Revenue comes from selling these technologies to hospitals, clinics, and individual practitioners, with engagement also involving administrators and payors to align value and reimbursement. The company adheres to regulatory standards to ensure safety and effectiveness, partnering with regulators and stakeholders to bring compliant technologies to market. Overall, Mendaera’s goal is to improve patient outcomes, boost patient satisfaction, and reduce the cost of care by making medical interventions more efficient at the point of care.
Company Size
51-200
Company Stage
Series B
Total Funding
$97M
Headquarters
San Carlos, California
Founded
2020
Simplify's Take
What believers are saying
- First procedures completed September 2025; full commercialization launch planned for 2026.
- Expanding from urology to multiple specialties addresses hundreds of millions of annual procedures.
- Healthcare provider workforce shortages create urgent demand for precision automation at point-of-care.
What critics are saying
- Intuitive Surgical dominates surgical robotics; could extend into handheld interventions and block Mendaera.
- Reimbursement payers may classify Focalist as incremental improvement, capping pricing power.
- Limited early adoption or complications in urology cases delay 2026 commercialization and market confidence.
What makes Mendaera unique
- Focalist combines handheld robotics with real-time ultrasound imaging for precise needle placement.
- FDA-cleared system addresses clinical skill variability requiring years of training to master.
- Partnerships with Cook Medical and EchoNous integrate market-leading needles and portable ultrasound.
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Benefits
Professional Development Budget
Growth & Insights and Company News
6 month growth
↑ 3%1 year growth
↑ 0%2 year growth
↑ 5%Mendaera, a healthcare robotics firm, secured $73 million in Series B funding, following a $24 million Series A led by Lux Capital in 2023. The funds will help scale their robotic and AI technologies for medical procedures like biopsies and organ access. Mendaera is expanding partnerships, including with Cook Medical and EchoNous, to enhance needle-based interventions. They also acquired Avail Medsystems' telepresence tech to improve patient access and care delivery.
Cook Medical collaborates with Mendaera(TM) to advance needle-based intervention with handheld robotics.
Mendaera appoints medical robotics leader Eric Davidson as Chief Commercial Officer.
Mendaera has secured $73M in venture capital to advance its handheld robotics platform for needle-based procedures like biopsy and vascular access. The Silicon Valley startup aims to address healthcare provider shortages and rising demand by integrating real-time imaging with robotic guidance. The Series B funding was led by Threshold Ventures, with participation from Lux Capital and others, to enhance patient care and expand access to high-quality medical procedures.
Portable ultrasound company EchoNous and AI and robotics company Mendaera have established a commercial partnership to develop new ultrasound-guided technology for interventional procedures.