Medical Device Assembler II (Cleanroom)

Rhevera Medical; Santa Rosa (CA); On-site; USD 30,000 - 34,000; Full time

Benefits offered by this job

Competitive pay

Solid benefits

Career growth

Culture that cares

Job summary

Endologix LLC is seeking a Manufacturing Associate II to join our manufacturing team in Santa Rosa, CA. You will assemble medical devices per approved instructions, maintain cleanroom standards, and participate in process improvements with engineers and technicians.

The role emphasizes GMP/GDP, accurate documentation in DHRs, and ongoing quality checks. 2–4 years of regulated manufacturing experience and a high school diploma are required.

Qualifications

• Requires high school diploma or GED; associate degree preferred.
• 2–4 years in medical device manufacturing or regulated life sciences.
• Experience in cleanroom and aseptic techniques essential.
• Familiarity with GMP/ISO 13485 and DHRs is preferred.

Responsibilities

• Assemble high‑quality medical devices per SOPs and process instructions.
• Perform in‑process quality checks and provide timely feedback.
• Maintain cleanroom protocols, PPE, and traceability records.
• Identify safety, quality, or process concerns and escalate appropriately.
• Collaborate with engineers and technicians to resolve line issues.
• Document production activities in DHRs and batch records.
• Support lean and 5S initiatives and continuous improvement.

Skills

Cleanroom experience

Aseptic techniques

Attention to detail

Team collaboration

Problem solving

Time management

Documentation accuracy

Communication skills

Mentoring junior staff

Shift flexibility

Education

High school diploma or GED

Associate degree in life sciences/engineering

GMP/Quality systems coursework or certification

Tools

ERP/MES systems

MS Office

Microscopes

Hand tools and fixtures

Measurement equipment

Device History Records (DHR) documentation

Job description

Endologix LLC is seeking a Manufacturing Associate II to join our manufacturing team in Santa Rosa, CA. You will assemble medical devices per approved instructions, maintain cleanroom standards, and participate in process improvements with engineers and technicians.

The role emphasizes GMP/GDP, accurate documentation in DHRs, and ongoing quality checks. 2–4 years of regulated manufacturing experience and a high school diploma are required.