30-person commercial-stage medical device startup seeking a hands-on Manufacturing Technician to support the production, testing, and assembly of our innovative gastrointestinal implant and delivery system. This individual will play a critical role in building medical devices, supporting manufacturing process development, troubleshooting production issues, and helping scale operations as the company continues commercial growth.
The ideal candidate enjoys working in a fast-paced startup environment, takes pride in producing high-quality products, and is comfortable working closely with Manufacturing, Engineering, and Quality teams.
Responsibilities
- Perform assembly, inspection, testing, packaging, and labeling of medical device components and finished products according to approved procedures and work instructions.
- Support manufacturing operations for both implantable devices and catheter/delivery system products.
- Maintain accurate production records, Device History Records (DHRs), travelers, and associated manufacturing documentation.
- Operate and maintain production equipment, fixtures, tools, and test systems.
- Assist Manufacturing Engineers with process development, validation activities, and continuous improvement initiatives.
- Identify, troubleshoot, and communicate manufacturing issues, non-conformances, and equipment problems.
- Ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and company quality procedures.
- Assist with inventory management, material handling, and production scheduling activities as needed.
- Support manufacturing scale-up efforts as production volumes increase.
Required Qualifications
- 4 - 6+ years of experience in medical device, life sciences, or other regulated manufacturing environments.
- Medical device manufacturing experience.
- Experience working in an ISO 13485 and/or FDA-regulated environment.
- Strong mechanical aptitude and experience using hand tools, fixtures, and manufacturing equipment.
- Ability to read and follow detailed work instructions, drawings, and assembly procedures.
- Experience documenting work accurately and maintaining production records.
- Strong attention to detail and commitment to quality.
- Comfortable working in a team-oriented startup environment.
- Ability to stand for extended periods and perform repetitive assembly tasks.
Preferred Qualifications
- Experience with catheter assembly, implantable devices, or precision mechanical assemblies.
- Familiarity with cleanroom manufacturing practices.
- Experience supporting IQ/OQ/PQ validations and process verification activities.
- Basic understanding of GMP, Design Controls, and manufacturing documentation requirements.
- Soldering, adhesive bonding, crimping, laser marking, or similar precision assembly skills.
Key Attributes
- Hands-on and mechanically inclined.
- Detail-oriented with strong quality focus.
- Self-motivated and dependable.
- Able to work effectively in a growing startup environment.
- Strong English communication and teamwork skills.
- Eager to learn new processes and technologies.
Local Candidates only
Must Have US Work Authorization, no VISA sponsorships
