Manufacturing Associate
Location: On-site: Newark, CA
Type: Full-Time, Hourly, OnSite
Company: Hound Diagnostics
Hound Diagnostics is a rapidly growing drug testing organization, developing next-generation laboratory testing solutions. We are seeking a Manufacturing Associate to contribute to the commercial production of novel, medical diagnostic devices. You will operate equipment and assemble products in a clean or dry room environment while adhering to strict quality policies and procedures.
Immediate Needs
· Support build-out and setup of the AC line in H2 and base station line in SR1 (cleaning, staging, construction).
· Complete onboarding and training on core commercial processes (gowning/cleanroom, ESD, traceability, documentation, safety).
· Provide hands-on production support: kitting, basic assembly, in-process checks, packaging/labeling, and rework to meet early build schedules.
· Assist receiving and inventory organization: unpacking, labeling, cycle counts, sorting/disposing of legacy inventory, and accurate transactions.
· Perform miscellaneous lab/manufacturing support tasks as assigned (basic measurements, fixture setup, material prep).
Long-Term Needs
· Execute routine commercial manufacturing across H2, SR1, and TRT, meeting throughput, quality, and documentation requirements.
· Own daily inventory management (receiving support, material moves, cycle counts, Kanban/min-max restocking) to ensure uninterrupted production.
· Contribute to continuous improvement: propose/implement process and fixture improvements, participate in CAPA/deviation investigations, and support validation/scale-up.
· Cross-train across product lines and stations to provide flexible staffing and support future expansion.
Responsibilities
Technical
Works closely with a team of manufacturing associates to assemble products and support product testing.
Assists process engineering / production management in identifying, documenting, and implementing assembly processes and process improvements.
Follow detailed instructions, maintain accurate records, and complete product inspections that meet all requirements. Experience with GMP, GDP, and following MPI guidelines is preferred.
Excellent manual dexterity with the ability to work with small parts and complex electromechanical devices in a controlled and regulated manufacturing environment for extended periods of time.
Effectively utilizes tooling and equipment commensurate with assembly operations including hand tools, semi-automated assembly equipment, automated testing applications, etc. Examples include but are not limited to pliers, screwdrivers, crimping tools, calipers, and pneumatic dispensing systems.
Performs inspections of components, assemblies, electronics, and packaging.
As requested, performs inventory transactions / movements in accordance with established policies and procedures.
Ensure compliance with safety policies and practices and escalate any product quality or workplace safety issues.
Maintains housekeeping standards in production and engineering areas to company expectations.
As requested, supports facilities maintenance, R&D lab testing operations, and other duties as assigned.
Expected Hours of Work
Full-time, hourly position.
Days and hours of work may be variable depending on business need.
Due to the “startup” nature of the company, occasional evening and weekend work may be required as job responsibilities demand.
Physical Requirements
Exposure to moderate to loud noise and light as typical in a manufacturing environment.
Ability to stand and sit for extended periods of time and lift 50lbs unassisted.
Fine motor skills to handle, manipulate, and assemble small components.
Work within a controlled clean/dry room environment as required for product and manufacturing support.
Experience
· 2+ years of hands-on experience in a regulated manufacturing environment (medical device, diagnostics, biotech, or pharmaceutical).
· Experience performing assembly, kitting, labeling/packaging, and basic in-process inspection activities while meeting production schedules.
· Working knowledge of Good Manufacturing Practices (GMP) and/or Good Documentation Practices (GDP); experience completing batch records, travelers, or device history records (DHR) is a plus.
· Experience working in controlled environments (cleanroom, dry room, ESD-controlled area) and following gowning, line clearance, and contamination-control procedures.
· Comfortable using basic hand tools and measurement equipment (e.g., torque drivers, calipers, scales) and following work instructions/SOPs.
Knowledge & Skills
· Proficient in computer systems: Windows, Microsoft Word, Excel, PowerPoint and various file repositories.
· Ability to read and follow detailed instructions, maintain accurate records, and complete product inspections that meet all requirements.
· Understands and adheres to applicable production controls including but not limited to line clearance, gowning, ESD controls, PPE, etc.
· Good communication skills (written and verbal [English]), good penmanship, is detail oriented and ability to perform basic arithmetic.
· Understanding basic principles and function of common electronic and mechanical components.
Why Join Us
- Join a confidential, high-impact drug testing organization
- Play a key role in building manufacturing and validation processes from the ground up
- Work in a collaborative, fast-paced, and technically challenging environment
- Competitive compensation and benefits
Salary range: $25-$30/hour depending on experience
Due to the confidential nature of our work, additional details will be shared during the interview process.
Apply here or contact us directly to learn more. Applicants only. No staffing agencies.
Pay: $25.00 - $30.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Application Question(s):
- No Visa sponsorship required
Experience:
- GMP manufacturing: 2 years (Preferred)
Language:
Work Location: In person
