Job Description

Job Description

Job Description

Must have experience and not remote!!

Job Title: Medical Device Assembler
Location: Santa Rosa, CA
Schedule: Monday through Thursday, 5:00 AM – 3:30 PM
Pay Range: $20 – $23/hour DOE
Environment: Clean Room

Position Summary:
We are seeking a detail-oriented Medical Device Assembler to join our team in Santa Rosa. The successful candidate will be responsible for assembling high-quality medical devices in compliance with approved manufacturing process instructions and Standard Operating Procedures (SOPs). This role involves active participation in evaluating and resolving production line issues, contributing to process improvement initiatives, and maintaining the highest standards of quality and safety. Additional duties may be assigned as required.

Key Responsibilities:

• Adhere to all safety rules, company policies, procedures, and stretching/exercise programs.
• Assemble medical devices using small hand tools, calibrated instruments, measurement equipment, microscopes, and test fixtures.
• Identify, report, and escalate safety, quality, and process issues to supervisors or engineering personnel as appropriate.
• Maintain clean room integrity by wearing proper attire and following controlled environment protocols.
• Perform in-process quality checks and provide timely feedback on any issues or deviations.
• Recognize and report unacceptable materials or sub-assemblies to engineering and/or supervisory staff.
• Ensure full compliance with Quality and Regulatory policies and uphold company Core Values.
• Maintain accurate quality records and follow prescribed manufacturing methods.
• Demonstrate understanding and compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Collaborate with supervisors, engineers, and technicians to resolve production line issues and suggest process improvements.
• Participate in Lean manufacturing initiatives and 5S improvement efforts.
• Understand production terminology and common manufacturing defects, and take corrective action as needed.
• Demonstrate flexibility by performing tasks at multiple workstations with minimal error.
• May serve as a certified trainer to onboard and train production staff on manufacturing processes.
• Read and interpret engineering drawings, specifications, and method sheets.
• Accurately enter data into electronic systems as required.

Qualifications:

• High school diploma or equivalent.
• Basic proficiency in reading, writing, and verbal English communication.
• Fundamental math skills.
• Ability to work with small components, adhesives, and microscopes.
• Attention to detail and commitment to quality and safety standards.

Work Environment:

• Clean room environment with controlled protocols.
• Monday through Thursday schedule, 5:00 AM – 3:30 PM.
• Hands-on role requiring precision and focus.

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