Full-Time
Staff NPI Engineer
Confirmed live in the last 24 hours
Mendaera
51-200 employees
Healthcare technology for point-of-care interventions
Compensation Overview
$168k - $211kAnnually
Senior, Expert
San Mateo, CA, USA
- 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
- 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 advanced technology solutions that improve point-of-care interventions, allowing healthcare providers to perform medical procedures accurately at the patient's location. Their products are designed to enhance efficiency, speed up recovery times, and reduce healthcare costs for hospitals, clinics, and individual practitioners. Mendaera collaborates with regulators to ensure their innovations are safe and effective, setting them apart from competitors. The company's goal is to transform healthcare delivery by making medical procedures more precise and improving patient outcomes.
Company Size
51-200
Company Stage
Series B
Total Funding
$97M
Headquarters
San Carlos, California
Founded
2020
Simplify's Take
What believers are saying
- $73M Series B funding accelerates robotics and AI technology development and market penetration.
- Eric Davidson's appointment as CCO enhances strategic growth and partnership opportunities.
- Support from Dr. Fred Moll provides industry insights and credibility for regulatory approvals.
What critics are saying
- Integration of Avail's telepresence tech may delay product rollouts or affect quality.
- Reliance on venture capital funding pressures Mendaera for quick returns, risking strategic missteps.
- Rapid AI and robotics advancements may outpace Mendaera's ability to keep up, risking obsolescence.
What makes Mendaera unique
- Mendaera integrates robotics, AI, and real-time imaging for precise point-of-care interventions.
- The company collaborates with EchoNous to enhance ultrasound-guided interventional procedures.
- Mendaera's acquisition of Avail Medsystems' telepresence technology boosts remote healthcare capabilities.
Help us improve and share your feedback! Did you find this helpful?
Benefits
Professional Development Budget
Growth & Insights and Company News
6 month growth
↓ -3%1 year growth
↑ 8%2 year growth
↓ -5%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.
Mediwhale, an AI-powered health diagnostics company, raised $12 million in Series A2 funding led by Korea Development Bank, with participation from Woori Venture Partners, IMM Investment, and Mirae Asset Securities. The funds will enhance AI algorithms, seek U.S. FDA approval for Reti-CVD, expand globally, and develop new products. Movement Labs' partners raised $13.2 million, Tetrix secured $5 million, and Bot Auto raised $20 million in their respective funding rounds.
Mendaera announced $73 million Series B funding round led by Threshold Ventures to scale robotics and AI across mainstream medical procedures.