||Manufacturing Eng/Sr Manufacturing Engineer
• 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.
• Experience with design and development of medical device products.
• 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, 6-8 years of Design and/or Manufacturing Engineering experience.
• Ph.D. in Mechanical, Chemical or Materials Engineering with 4-6 years of Design and/or Manufacturing Engineering experience.
• Candidate should be well versed in Design For Manufacturing (DFM)
• Experience validating processes and or designs
• Experience with GMP-regulated pharmaceuticals or QSR regulated medical devices.
• Knowledge on design of experiments, Solidworks and statistics.
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