Role : Equipment Engineer
Location : Santa Clara, CA 95051
Duration : 12 months contract
• BA or BS Degree in science or technology
• 2 – 5 years of manufacturing engineering or manufacturing experience in a pharmaceutical or medical device industry
• Working knowledge of FDA QSRs, ISO 9001/13485, and risk management (ISO 14971).
• Computer literate with excellent oral and written communication skills. Good interpersonal and persuasion skills.
• Self-motivated and works with limited supervision
• General equipment knowledge of electrical, mechanical engineering.
• Program Project Management.
• Advanced statisitcs
• Advanced electronics and/or software knowledge.
• Solidworks/ProE/AutoCad design software knowledge
Primary Duties and Responsibilities:
• Primary technical interface between Development, Field Service, Application Support and the instrument contract manufacturer(s).
• Facilitates meetings with instrument contract manufacturer and provides guidance on design changes, parts obsolescence, and any field service instructions. This will require coordination between various departments, sites, and outside suppliers/contract manufacturers.
• Review and approve ECO / CO’s and technically assess impact to instrument performance.
• Coordinate the creation of specifications, part numbers, batch records, JDE data, and logistic processes for new products. Insure that validations and other corporate requirements for new product introduction are satisfied. This would include technical leadership in audits and support any regulatory requirements around product labeling /safety.
• Manufacturing sustaining, performs & leads advanced equipment repairs, revision of PM DOPs.
• CAPEX equipment improvements, mfg. support, and transfer of new equipment from development.
• Ensure that processes and new products are compatible with operations/manufacturing requirements to support the transfer and implementation of new products & processes.
• Responsible for analysis of key manufacturing and QC/process control metrics.
• Participates in process and operation improvement opportunities.
• Complies with company quality management systems, policies and procedures.