D&K Engineering is looking for a Sr. Manufacturing Engineer with medical device experience to work at their Rancho Bernardo location.
Develops, implements and maintains methods, operation sequence and processes in the manufacture or fabrication of parts, components, subassemblies and final assemblies. Interfaces with R&D (engineering) in coordinating the release of new products in accordance with the phase gate driven product realization process. Estimates manufacturing cost, determines time standards and makes recommendations for tooling and process requirements of new or existing product lines. Maintains records and reporting systems for coordination of manufacturing operations. Interfaces with clients to help create plans and provide status updates in conjunction with operations and/or R&D. Prior experience with Process Simulation software required; preferredexperience with Solidworks preferred.
These may include, but are not limited to:
- Experience with medical device manufacturing and ISO 13485.
- Create and modify work instructions. Provide training and support to assemblers and leads.
- Conduct time and motion studies and implement work stations
- Design, develop, characterize, validate and release test apparatus as needed for the production of products.
- Design, develop and release test procedures with acceptance (P/F) criteria for testing products at both subassembly and final assembly levels for use with the test apparatus in production.
- Design, develop, implement and monitor process control mechanisms on manufacturing lines.
- Develop and implement process improvements to enhance process control capabilities.
- Identify and implement technology solutions that collect data and measure process variables.
- Read and interpret prints, technical drawings, schematics, and computer-generated reports. Able to use CAD and configuration management tools.
- Analyze client requirements in order to map out production (assembly and test) processes.
- Assist R&D in the development of products by providing manufacturability, ease of assembly, and other inputs as appropriate. Feedback learnings from production to improve manufacturability of new R&D programs.
- Confer with engineers and other personnel to implement operating procedures, resolve system malfunctions, and to provide technical information to support production needs.
- Develop and test models of alternate designs and processing methods to assess feasibility, operating condition effects, possible new applications and necessity of modification
- Recommend design modifications to eliminate product, subassembly or system malfunctions.
- Performs other duties as assigned, e.g. collect and publish production metrics, assist in general production support.
Experience and Skills:
Education & Experience:
Typically requires 5+ years of experience, and a mechanical, electrical or industrial engineering Bachelor’s degree from four-year College or university, or the equivalent combination of education, experience and training that provides the required knowledge, skills and abilities.
Knowledge, Skills & Abilities:
- Strong grasp of MANUFACTURING principles, e.g. LEAN, VSM, PFMEA, DFx, throughput, utilization, cycle time, process capability and control, process flows, facility layout, Engineering Change Control, CAPA, and testing strategies, along with how to most effectively use them.
- Understanding Six Sigma root-cause analyses and problem solving tools, e.g. 8-D, FMEA, Gauge R&R, SPC, FMEA, fishbone diagrams, 5 Whys
- Able to apply manufacturing engineering knowledge to create appropriate production methods, e.g. assembly and test instructions, inspection and test methods and acceptance criteria.
- Understanding of 2D drawings for use in dimensional inspection and metrology best practices.
- Experience supporting low volume, high complexity and high volume, low mix manufacturing.
- Experience with the product realization life cycle from prototype to pilot and into production.
- Understanding of FASTENING methods, along with how to most effectively use them, e.g. fasteners, rivets, weldments, ultrasonic welding, heat staking, adhesives.
- Understanding of modern FABRICATION techniques, along with how to most effectively use them, e.g. milling/turning, injection molding, roto-molding, extruding, casting, sheet metal, laser or dye cutting, water jet, plunge and wire EDM, vacuum forming, anodizing, and surface coating.
- Understanding of DRIVE components (e.g. motors, solenoids, encoders, gears, belts, pulleys, clutches, bearings) and FLUIDIC HANDLING components (e.g. pumps, fans, seals, valves, transducers, flow meters, filters) to provide appropriate manufacturing engineering support.
- Understanding of electricalcircuits, PCA fabrication, grounding, and reading schematics.
- Experience using test software or scripts for testing to support manufacturing appropriately.
- Knowledge of regulatory processes and requirements (CE, UL, FDA, etc.).
- Able to contribute in both internal and external technical meetings with other disciplines.
- Capable of assessing program issues and raising issues to program manager as appropriate.
- Excellent attention to detail, and collaboration and teamwork skills.
- Excellent communication and presentation skills (written and oral).
- Prior experience with Process Simulation software required; previous experience with Solidworks preferred.
- Able to assist with business development on estimates for new opportunities as appropriate.
Tracking ID: 512229-661663