Medical Device Assembler II

huMannity Medtec; Santa Clarita (CA); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

9/80 schedule

Job summary

huMannity Medtec in Valencia, CA, is seeking an experienced Medical Device Assembler II to join our team. You will perform precision hand soldering, assemble micro-electronic components, and conduct inspections under microscopes in a regulated lab and cleanroom environment.

The role emphasizes GMP/ISO 13485 compliance, detailed documentation, and collaboration with Engineering to drive manufacturability improvements.

Qualifications

• High school diploma or GED required.
• 5+ years in medical device manufacturing or regulated industry.
• Expert-level hand soldering skills.
• Experience reading schematics, blueprints, and drawings.
• Experience working under microscopes with micro-electronic components.
• Strong troubleshooting, problem solving, and analytical skills.
• Excellent attention to detail and documentation accuracy.
• Ability to work both independently and in a fast-paced team.
• Strong communication and teamwork skills.

Responsibilities

• Perform precision hand soldering of electronic components and assemblies.
• Assemble micro-electronic and hybrid components using specialized tools.
• Conduct electrical testing with automated and semi-automated equipment.
• Inspect and verify components throughout manufacturing processes.
• Troubleshoot assemblies, boards, and device components.
• Maintain GMP, ISO 13485, and FDA compliance in documentation.

Skills

Hand soldering

Microscope inspection

Schematics reading

ESD handling

Documentation accuracy

Teamwork

Education

High school diploma or GED

Tools

Microscopes

Test equipment

Job description

Build a career that makes an impact.

At huMannity Medtec, you don’t just build a career, you help change lives.

For over 40 years, we have been advancing life-enhancing medical technologies that address unmet healthcare needs. Our teams bring together engineering, science, and clinical expertise to transform bold ideas into solutions that can make a difference for patients around the world.

We believe meaningful work and a balanced life go hand in hand. That is why we offer a 9/80 schedule, giving our employees every other Friday off. That means 26 extra long weekends each year to recharge, spend time with family and friends, pursue hobbies, or simply enjoy more balance outside of work.

Why huMannity Medtec?

• Mission-driven work that impacts lives
• A 9/80 schedule with every other Friday off (26 long weekends a year!)
• Collaborative teams solving complex challenges
• Opportunities to learn, grow, and make an impact
• Weekly team traditions, monthly lunches, and quarterly events that bring us together

Here, your work has purpose. Your ideas are valued. Your curiosity is encouraged.

Ready to be part of something meaningful?

Position Summary

We are seeking an experienced Medical Device Assembler II to join our team and support the assembly, testing, inspection, and documentation of innovative medical device products. This role is responsible for precision micro-electronic assembly in a regulated laboratory and cleanroom environment and requires exceptional hand soldering skills, strong attention to detail, and the ability to work with small, delicate components under microscopes. This is a full-time onsite position based in Valencia, California.

The ideal candidate will bring expertise in medical device manufacturing or other highly regulated industries and enjoy collaborating closely with Engineering throughout research, development, and production activities. This position also serves as a technical resource by providing manufacturability feedback, supporting process improvements, and helping train other team members.

What You'll Do

Electronics Assembly & Manufacturing

• Perform precision hand soldering of electronic components and assemblies.
• Assemble micro-electronic and hybrid components using specialized tools, materials, and processes.
• Perform mechanical assembly operations, including crimping, bonding, welding, staking, press-fitting, and fastening.
• Assemble and inspect miniature components under low- and high-power microscopes.
• Work with ESD-sensitive electronic assemblies and delicate medical device components.
• Support cross‑training efforts and serve as a subject matter expert for critical manufacturing processes.

Testing & Troubleshooting

• Perform electrical testing using automated and semi-automated test equipment.
• Conduct inspections and verification activities throughout the manufacturing process.
• Troubleshoot electronic assemblies, circuit boards, and device components.
• Make adjustments to assemblies as needed to meet electrical and dimensional requirements.

Quality & Compliance

• Follow Standard Operating Procedures (SOPs), work instructions, Good Manufacturing Practices (GMP), and regulatory requirements.
• Complete manufacturing documentation, work orders, travelers, and Device History Records (DHRs) accurately and on time.
• Perform incoming, in-process, and final inspections.
• Ensure compliance with ISO 13485, ISO 9001, FDA requirements, and company quality standards.
• Maintain full traceability of materials, components, and finished devices.

Engineering & Continuous Improvement

• Partner closely with Engineering teams throughout product development and production.
• Provide feedback on manufacturability and assembly processes.
• Support the development and revision of manufacturing documentation.
• Participate in process improvement initiatives focused on quality, efficiency, and yield improvements.

Lab & Equipment Support

• Support cleanroom and laboratory operations while maintaining GMP standards.
• Assist with inventory coordination and materials management.
• Support equipment calibration and preventative maintenance activities.
• Perform ESD testing and monitor manufacturing equipment performance.

What We’re Looking For

Required Qualifications

• High school diploma or GED.
• 5+ years of experience in medical device manufacturing or another highly regulated industry.
• Expert-level hand soldering skills.
• Experience working under microscopes assembling and inspecting micro-electronic components.
• Strong understanding of ESD-sensitive assemblies and handling requirements.
• Ability to read and interpret schematics, blueprints, and technical drawings.
• Strong troubleshooting, problem-solving, and analytical skills.
• Exceptional attention to detail and documentation accuracy.
• Ability to work independently and collaboratively in a fast-paced environment.
• Strong communication and teamwork skills.

Preferred Qualifications

• IPC-A-610 or similar soldering certification.
• Experience with PC boards, cabling, and precision tooling.
• Experience with laser welding, resistance welding, or brazing.
• Experience working with epoxies, specialty adhesives, potting, and encapsulation processes.
• Experience supporting research and development environments.
• Familiarity with FDA-regulated manufacturing environments and quality systems.