Job Title: Equipment Engineer
Location: Santa Clara, California 95051
Duration: 12 Months (Possibility of extension)
Manages production support engineering for a specific product or group of products after transfer from design to high volume production. Interfaces with design, process, test and reliability engineering to solve problems. Sustains products with cost reduction and yield improvements. Primary contact between Affymetrix and contract manufacturer of instrumentation product line.
Responsible for equipment engineering support for the chip manufacturing organization. Performs engineering assignments of varying complexity under general management direction to improve and keep manufacturing equipment on-line. Execute and leads advanced equipment repairs. Performs IQ and OQs on tools. Responsible for monitoring key operational instruments, and equipment process parameters used in chip manufacturing. Participates in equipment procurement and transfers from development. Applies knowledge of engineering, mathematics, software, and/or computer sciences to identify, analyze, and solve complex equipment problems.
Provides technical and sustaining engineering support to all aspects of operations. Also, establishes and refines operating specifications, improves manufacturing techniques and production yields, and introduces new processes to improve production efficiencies.
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. Ensure 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
- Additional duties/responsibilities according to business needs.
- BA or BS
- Degree in science or technology
- Experience with molecular biology and/or chemistry
Years of related experience:
- 2 – 5 years of manufacturing engineering or manufacturing experience in a pharmaceutical or medical device industry
- 0 – 3 years of instrument related manufacturing experience
Competencies: (skills, knowledge, abilities)
- 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 statistics
- Advanced electronics and/or software knowledge.
- Solidworks/ProE/AutoCad design software knowledge.
Level of Autonomy and Complexity:
- Regularly contributes to the conception of new principles, theories, and concepts, to resolve complex issues.
- Employs judgment in choosing creative techniques to resolve complex issues requiring extensive analysis and evaluation of factors.
- Error in judgment or failure to achieve objectives will hinder accomplishment of business goals and will have prolonged impact.
- Determines own methods for new projects; acts as team leader; employs scope to determine goals for assignments.
Product Quality Assurance