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huMannity Medtec
huMannity Medtec
51 – 200 Angajați
Asistență medicalăB2BHardware
huMannity Medtec este o organizație de dezvoltare a tehnologiilor medicale, cunoscută anterior sub numele de Alfred Mann Foundation, dedicată promovării neurotehnologiei și dispozitivelor medicale implantabile. De aproape patru decenii, echipele sale multidisciplinare de ingineri, oameni de știință și specialiști în dispozitive medicale au sprijinit inovațiile, de la cercetarea inițială și dezvoltarea conceptelor până la comercializare. Activitatea sa a inclus membre protetice, implanturi cohleare, proteze retiniene și tehnologii de neuromodulare. huMannity Medtec colaborează, de asemenea, cu inventatori și parteneri strategici și comerciali pentru a contribui la aducerea dispozitivelor promițătoare la pacienți, punând accent pe răspunsul la nevoile comunităților insuficient deservite.
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Locurile de muncă ale companiei

Manufacturing Engineer I, Implantable Medical Devices (Onsite)

Support the development, validation, transfer, and production of implantable medical devices at huMannity Medtec. Partner across engineering, quality, supply chain, and manufacturing to improve processes, efficiency, reliability, and regulatory compliance.

USStatele Unite ale AmericiiCACalifornia
85.000 $ – 92.000 $ / an
La sediuNormă întreagăJuniorLimbă Obligatorie: englezăInginer

Descriere

  • Support development, transfer, optimization, and production of implantable medical devices and systems
  • Partner with R&D on product development, design transfer, and manufacturing readiness
  • Develop, validate, and improve manufacturing processes
  • Support IQ, OQ, and PQ validation protocols and reports
  • Create and maintain SOPs, work instructions, PFMEAs, and process specifications
  • Coordinate product and process transfers with suppliers, contract manufacturers, and remote production sites
  • Evaluate and qualify materials, equipment, tooling, and suppliers
  • Provide hands-on engineering support during manufacturing operations and production builds
  • Investigate manufacturing, equipment, and process problems through root cause analysis
  • Assist with production planning, workflow refinement, and manufacturing efficiency initiatives
  • Review production data and process performance metrics
  • Support work-order execution, build tracking, and resolution of production obstacles
  • Lead continuous improvement efforts targeting quality, yield, reliability, and cost
  • Contribute to CAPA activities involving manufacturing processes and equipment
  • Improve layouts, workflows, resource allocation, and equipment performance
  • Support preventive maintenance and equipment reliability programs
  • Design and implement tooling, fixtures, and other manufacturing solutions
  • Maintain compliance with GMP, ISO 13485, FDA Quality System Regulations, and company procedures
  • Assist with internal and external audits
  • Contribute to risk management, process control, and quality improvement programs
  • Work collaboratively with Quality Assurance and Supply Chain teams

Cerințe

  • Bachelor’s degree in Mechanical, Manufacturing, Biomedical, or Materials Engineering, or a related engineering field
  • At least one year of engineering experience gained through industry work, internships, co-ops, or comparable hands-on experience
  • Background supporting manufacturing processes, process improvement, or product development
  • Ability to interpret engineering drawings and CAD models
  • Experience with SolidWorks, AutoCAD, or comparable CAD software
  • Understanding of process validation, risk management, and manufacturing documentation
  • Proficiency with Microsoft Office, including Excel, Word, PowerPoint, and Outlook
  • Strong analytical, troubleshooting, and problem-solving abilities
  • Clear written and verbal communication skills
  • Highly organized, self-directed team contributor with careful attention to detail
  • Preferred: Experience in medical devices or another highly regulated manufacturing setting
  • Preferred: Knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, ISO 14971, and GMP
  • Preferred: Experience supporting IQ, OQ, and PQ validation activities
  • Preferred: Familiarity with PFMEA, risk management, and Minitab or JMP statistical tools
  • Preferred: Experience contributing to New Product Introduction programs
  • Preferred: Familiarity with cleanroom manufacturing
  • Preferred: Lean Six Sigma certification or continuous improvement training
  • Preferred: Experience transferring products or processes between manufacturing sites or suppliers
  • Nice to have: Experience with implantable medical devices and implantable materials
  • Nice to have: Hands-on experience with precision processes such as micro-machining, laser processing, welding, brazing, wire bonding, soldering, molding, or surface finishing
  • Nice to have: Experience with medical-grade polymers, silicones, adhesives, ceramics, titanium, platinum, or comparable implantable materials
  • Nice to have: Familiarity with hermetic systems, electrical testing, automation, or high-volume manufacturing

Beneficii

  • 9/80 work schedule with every other Friday off
  • 26 additional long weekends each year
  • Opportunities for learning, growth, and meaningful impact
  • Weekly team traditions
  • Monthly team lunches
  • Quarterly company events
  • Mission-focused work intended to improve lives

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