Senior Cost Accountant

Medical Device R&D build assembler
Pay $28-32
6 month+ assignment
Onsite in Campbell, CA
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 include the following:

• 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.

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

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.
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