Assembler

inSync Staffing; Campbell (CA); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Health insurance

Health savings account

Vision insurance

Flexible spending accounts

Life insurance

Job summary

inSync Staffing is seeking candidates with strong GMP and cleanroom experience for a role in Campbell, CA. You will work with medical devices, focusing on adhesive bonding, fluidics, and mechatronic assemblies.

Responsibilities include advanced troubleshooting, process improvements, and coaching teammates while maintaining strict safety and documentation standards.

Qualifications

• Minimum 4 years related experience in the medical device industry; or equivalent combination.
• Certified on all processes of work area, including critical processes.
• Strong in manufacturing, testing, and data collection.
• Proficient with GMP, GDP procedures and requirements on production lines.
• Excellent written and verbal communication; ability to train others.

Responsibilities

• Operate GMP-compliant manufacturing and packaging equipment per SOPs.
• Collaborate with manufacturing and engineering to meet product requirements.
• Perform complex troubleshooting and keep workspace and equipment clean.
• Ensure GDP guidelines and proper documentation are followed.
• Train others on manufacturing processes and procedures.

Skills

GMP Knowledge

Mechanical assembly

Troubleshooting

Documentation

Team training

Process improvement

Education

Certified Trainer

4+ years medical device experience

GMP/GDP training

Tools

Bonding equipment

Soldering

Cleanroom tools

MPI systems

Job description

must have uv cure adhesive bonding experience and prior experience with medical devices built in a clean room. experience supporting Engineering/R&D.

robotics/med device experience --- with cleanroom device assembly of fluidic, catheter adhesive bonding and mechatronic assemblies.

Education/Experience

• A minimum of 4 years related experience in the medical device industry; or equivalent combination of education and work experience.
• Must be certified on all processes of work area, including certified as expert on all critical processes.
• Training, skill, or experience from a trade is preferred.
• Highly skilled in product manufacturing, testing, and data collection.
• Proficient with GMP, GDP procedures and requirements as they relate to production lines.
• Strong ability to be reliable, work independently or in team setting and take initiative.
• Strong ability to coach and train others on manufacturing processes and procedures.
• High skill on operating manufacturing equipment (i.e. hot boxes, adhesives, soldering, bonding, fuse joining).
• Proficient with testing: tensile, simulated use testing, or tests related to assigned projects.
• Expert hand dexterity and ability to work with small components.
• Strong written and verbal communication skills.
• Strong computer skills, including knowledge of Microsoft office products.
• Strong interpersonal skills, effective interaction with Operations and other departments

Essential Duties and Responsibilities

• Operate with high skill, manufacturing and packaging equipment following Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP).
• Uses high level of expertise to work with in-house and contract manufacturers and ensure products are manufactured adhering to product plans, quality, and regulatory requirements.
• Collaborate with manufacturing and engineering personnel to understand product requirements, identify and implement process improvements.
• Perform complex troubleshooting and maintain workspace and equipment clean.
• Adhere to strict safety regulations of the company; maintain a safe, clean and organized work area, and ensure that others are doing the same.
• Perform manufacturing processes using Manufacturing Process Instructions (MPI’s), while assisting in the development of new processes or test procedures through feedback.
• Record and review accuracy of data on lot history records (LHR’s) in collaboration with manufacturing, quality, and R&D.
• Meet regular attendance and punctuality expectations and adhere to all company policies.
• Learn and adhere to safety requirements of manufacturing processes, equipment, handling of chemicals and materials, and apply high skills during complex operations.
• Accurately use computerized operating systems to run and monitor manufacturing equipment.
• May oversee the set up and operation of a variety of equipment to produce materials and assemblies.
• Monitor and record critical process parameters and ensure that proper documentation and GDP guidelines are followed by others.
• Contribute to manufacturing team meetings to ensure communication between members.
• Help build engineering prototypes and products used in preclinical/clinical evaluations.
• Must be a Certified Trainer and teach/train others on manufacturing processes.
• Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.
• Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA, and Regulatory requirements.

Benefits (employee contribution)

• Health insurance
• Health savings account
• Vision insurance
• Flexible spending accounts
• Life insurance

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.