POSITION DESCRIPTION
The purpose of the position is to assemble and service medical monitoring equipment and disposable medical devices. Position may include inspection and testing of components, sub-assemblies, and finished products. Participate in new product development through prototypical assembly, testing, and evaluation of future manufacturing processes.
ESSENTIAL FUNCTIONS (Included but not limited to)
Service Operations.
Performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, ISO 14971, the Canadian Medical Device Regulations, and all other international regulatory requirements with which Potrero Medical complies:
- Perform assembly, testing, inspection, and basic repair of the Accuryn Monitoring System and its components, including tubing assembly, transducer and pump assembly.
- Document all service activities accurately in the company's Quality Management System (QMS).
- Assist in maintaining service inventory, spare parts, and loaner equipment to ensure timely customer support.
- Support in-house and field service activities, including decontaminating the returned units (RMA), troubleshooting product issues and preparing replacement units for shipment.
- Perform basic calibration checks and functional testing of finished devices using prescribed test fixtures and equipment.
- Maintain a clean, organized, and ESD-safe work environment in compliance with company protocols.
New Product Introduction (NPI)
- Support the introduction of new products and product changes from development into manufacturing by participating in build events, pilot runs, and first article inspections.
- Build and test prototype and pre-production units under the direction of the NPI Lead or Engineering team.
- Document observations, anomalies, and feedback during NPI builds to help optimize manufacturing processes and product designs.
- Assist in maintaining design history files (DHFs) and device history records (DHRs) for NPI builds in alignment with FDA 21 CFR Part 820 requirements.
REQUIREMENTS
Education
- High school diploma or equivalent required.
Experience
- 0–2 years of experience in a manufacturing, assembly, or technical service environment (medical device, electronics, or similarly regulated industry preferred).
- Prior experience working with small electromechanical assemblies, printed circuit boards, or catheter/disposable medical device components is a plus.
- Familiarity with quality systems or regulated manufacturing environments is a plus.
Knowledge, Skills & Abilities
- Strong attention to detail with a quality-first mindset essential for working with Class II medical devices.
- Ability to read and follow written work instructions, SOPs, assembly drawings, and test procedures.
- Basic mechanical aptitude and comfort with hand tools, soldering (preferred), and precision assembly.
- Familiarity with basic computer applications (Microsoft Office)
- Ability to work effectively both independently and in a collaborative team environment.
- Strong communication skills — both verbal and written — with the ability to clearly document observations and service activities.
- Ability to prioritize and manage multiple tasks in a dynamic, fast-paced startup environment.
Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands and fingers to handle or feel; and reach with hands and arms.
- The employee is occasionally required to sit; balance; and stoop, kneel, or crouch. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus
WORK ENVIRONMENT
- This job operates in a professional office environment.
- This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets.
EQUAL EMPLOYMENT OPPORTUNITY (EEO) STATEMENT
We are an equal opportunity employer and value diversity in our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
ADDITIONAL INFORMATION
Benefits: Medical, Dental, Vision, 401(k), Gym subsidy, PTO, paid holidays, and more
Location: Onsite – Hayward, CA
Pay: $24 to $36 per hour
Pay: $24.00 - $36.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
