Senior Process Development Engineer

2 weeks ago

Carlsbad, United States Bolt Medical Full time

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES. RECRUITERS: DO NOT CONTACT.

SUMMARY OF THE JOB The Process Development Engineer designs, develops and optimizes manufacturing processes for design transfer to the production facility. Maximizes efficiency by analyzing equipment selection, characterization of process, process workflow, and fixture development. A Product Development Engineer optimizes parts, equipment, and tools needed to achieve manufacturing goals according to product specifications ahead of design transfer activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES Evaluate current catheter manufacturing practices and identify those needing improvement. Lead process development and optimization activities with Design for Manufacturing in mind. Seamlessly interface between R&D and Manufacturing. Draft design transfer documentation for multiple lines. Analyze and design sequence of operations and workflow to improve efficiencies and establish methods for maximum utilization of production facilities and personnel. Use Lean Manufacturing Methodology, including Value Stream Mapping and Kaizen events. Use Six Sigma Methodology (DMAIC or DMADV) and tools including Minitab, FMEA, Fishbone, Process Mapping, etc. Responsible for manufacturing process development, implementation, and continuous improvement to enhance yield, reduce cost and operator dependency. Represent Process Engineering in assigned R&D and Project Team meetings for technology transfers and provide technical expertise and support in analytical method development, validation and process scale, and current production capabilities in manufacturing. Performs or manages process validations (IQ/OQ, OQ, PQ). Troubleshoot production line issues related to yield, quality, and throughput. Leads scaling up processes from development to full scale manufacturing. Creates/Updates manufacturing instructions, routings, bills of materials and SOPs.

REQUIRED EDUCATION/TRAINING and/or EXPERIENCE: Bachelor's degree in a scientific/engineering discipline; or equivalent combination of education and experience. Minimum 2 year (QE II) or 5 year (Senior QE) of relevant work experience in either pharmaceutical, medical device, or other highly regulated industry.

KNOWLEDGE, SKILLS AND ABILITIES: Experience working in medical devices, while working within Quality is required. GMP experience working within ISO 13485 and FDA 21 CFR Part 820 environments. Capable of reviewing and interpreting drawings in performing test method validation and Gage R&Rs is preferred understanding of statistical techniques such as normality analysis, tolerance analysis, and should be able to analyze and interpret data with high confidence. know how to use Minitab or other statistical software Strong analytical, planning and organizational skills Strong interpersonal and communications skills (oral & written) Self-starter with ability to work independently under pressure and react quickly to changing priorities Proficient in MS Office (Word, Excel, Power Point, Project, Visio)

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