Randstad USA Looking for Associate Director, Sustaining / Process Development Engineer at Mountain View, CA Full Time

Description

Responsibilities

• Responsible for monitoring industrial operations, including the efficiency of processes and the performance of tools and equipment, ensuring high-quality deliverables for business objectives.
• Responsible for streamlining the process of taking plans for a product into development and full-scale production.
• Identify, review, assess and resolve deficiencies throughout the system’s life cycle
• Participate in the development of combination medical products for clinical trials and commercial production in accordance with 21CFR part 210/211 and 820.
• Planning and guides the development, implementation and maintenance of manufacturing methods, processes, and operations for new and existing products.
• Evaluates, selects, and orders equipment that is most appropriate and cost effective for the manufacture of company products.
• Leads and participates in the generation of product, component, assembly, and machine specifications, drawings, test protocols and reports.
• Oversees the installation, modification, upgrade and maintenance of manufacturing equipment. Studies equipment performance and reliability.
• Establishes programs and solutions for increasing uptime and for equipment problems that affect the manufacturing process.
• Develops and establishes maintenance requirements for production equipment.
• Develops and executes manufacturing instructions, validation protocols, and testing strategies for production equipment.
• Acts as a liaison to design engineering functions in developing and releasing new products.
• Manages and executes change protocols and requests for cGMP materials and equipment.
• Documents development efforts in the form of reports.
• Develops spares parts list for all production equipment and works with purchasing department in the ordering of spares parts.
• Able to perform failure analysis using pFMEA, root cause analysis and other problem solving techniques.
• Creates and executes IQ, OQ, PQ, and writes reports for custom equipment and tooling.
• Acts as manufacturing liaison with material suppliers and contract manufacturers.
• Provides daily production support on the day-to-day production activities.
• Work with production personnel to continually find opportunities for reducing cycle time, improving processes and increase yields while improving product cost.

Skills required

• Experience with design and development of combination products or equivalent.
• Excellent interpersonal and communication skills to allow effective participation in project teams
• Strong documentation skills
• Understanding of current Good Manufacturing Practices (cGMP), Quality System Regulations (QSR) including design control.
• Must be able to handle multiple priorities and work across multidisciplinary, multi-organizational, teams consisting of chemists, electrical and mechanical engineers.
• Self-starter with strong problem-solving skills
• Ability to work on multiple projects in a fast-paced, start-up environment with milestone driven time lines.
• Acts independently to plan for new assignments. May oversee activities of lower-level personnel
• Works on complex issues requiring imaginative solutions based on analysis of data from various factors.
• Exercises judgment in selecting methods, techniques and evaluation criteria for solving problems. Decisions have internal and external impact.

Education and experience

• B.S. or M.S. in Mechanical, Chemical or Materials Engineering with 8+ years of Design and/or Manufacturing Engineering experience or Ph.D. in Mechanical, Chemical or Materials Engineering with 6+ years of Design and/or Manufacturing Engineering experience.
• Familiar with the definition and execution of DOEs to determine the impact of independent variables on processes and designs.
• Familiar with risk-based design and process control methodologies utilizing tools like FMEAs or FTA.
• Experienced in the use of Pharmaceutical Quality by Design and Design for Manufacturability (DFM) approaches during scale-up and definition of commercial processes.
• Familiar with validating processes and or designs and the regulatory expectations associated with these activities.
• Experienced with the manufacture of cGMP-regulated pharmaceuticals or QSR regulated medical devices.
• Knowledge on the use of stat