Medical Device Assembler II
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
Responsibilities
- 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.
- 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.
- 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.
- 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.
- 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.
Benefits
- A 9/80 schedule with every other Friday off (26 long weekends a year!)
- Mission-driven work that impacts lives
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
