Process Design and Development - Katalyst Healthcares & Life Sciences

Job Description:
As Principal Engineer, Early Process Design and Development in Lake Forest, CA the ideal candidate will be a senior member of a high performing team, specialized in the design and development of processes, fixtures and test methods used in new product development.

In this role, you will be expected to:

• Embed as the Process Design and Development representative on R&D project teams responsible for estimating budgets and timelines for all process design and development activities on a project.
• Manage and prioritize multiple projects in a dynamic fast paced R&D environment and be self-accountable to ensure all project goals and objects are completed per committed timelines.
• Work well with and collaborate with cross-functional teams as well as provide technical expertise on a project and support both internal and external manufacturing sites as well as 3rd Party Manufacturers
• Communicate and present project status/risks to Leadership, and Project Leads to ensure adequate support is provided as well as timely escalation of issues to ensure project success.
• Collaborate with product design teams to ensure manufacturability of new designs is accounted for to ensure smooth transition from development to production.
• Plan, organize, schedule, and manage process design and development activities on projects in order to ensure concurrent engineering of new processes and technologies.
• Research, develop and introduce new technologies for use in the fabrication and testing of innovative product designs e.g.
  • Evaluate new products for manual and automated assembly, production, or manufacturing processes.
  • Design and fabricates prototype equipment and fixtures.
  • Investigates and integrates leading edge automation technology into new products as appropriate.
  • Creates CAD files, and pertinent documents for implementation of manual, semi-automated and automated component fabrication and electro-mechanical assembly and final testing.
  • Supplies knowledge and facilitates execution of process validation activities and documentation e.g. IQ/OQ/PQ
  • Leads bench testing method creation for new processes and technology.
  • Be able to retrofit existing processes and equipment with updated capabilities and technology.

• Work with design engineers and/or vendors to develop solutions to complex problems by designing processes, tools/fixtures that can work with various fabrication and assembly processes and equipment.
• Evaluate component, subassembly and/or assembly supplier capabilities and technologies for use in the development of new products.
• Coordinates and oversees builds at suppliers and evaluates for design, regulatory and business requirements.
• Utilize Six Sigma methodologies such as DMAIC or DFSS to characterize and optimize new process designs, develop performance criteria, equipment and/or test fixtures.
• Utilize risk management tools such as Fault Tree Analysis and Failure Mode and Effects Analysis to understand and quantify risks and understand design or process trade-offs.
• Creates and maintains a Process Flow Diagram for manufacturing and assembly of electro-mechanical medical devices.
• Creates and maintains initial standard operating procedures and test methods for Design Verification testing and/or manufacturing processes.
• Coordinates R&D Pilot Line builds and supports manufacturing builds as part of transfer activities.
• Provide coaching, mentoring, and training of team or less experienced engineers to build and strengthen the culture of the organization.

Skills/Experience:

• Exceptional communication and interpersonal skills, with the ability to work effectively at all levels of the organization and experience with conflict resolution.
• Excellent project management skills and experience leading cross-functional teams.
• Strong analytical, problem-solving, and decision-making capabilities.
• Proficient using 3D CAD software Creo Parametric modules: ISDX, Simulate, Pro-Process, Sheet Metal, Mechanism, Pro-Process, include employing top-down design and master model methodology. SolidWorks is a plus.
• Utilize Creo Parametric 3D CAD software to design, develop, and document plastic, die cast, sheet metal, and machine components for cutting edge ophthalmic surgical equipment.
• Practical experience with the design, development and qualification of tools, fixtures, and Test Methods e.g.
  • Robotics
  • Vision Systems
  • Laser Welding
  • Ultrasonic welding
  • Adhesive dispensing and curing

• Proficient in Geometric Dimension and Tolerancing (GD&T) and Tolerance stack-up Analysis
• Proficient in Design for Manufacturing (DFM), Design for Assembly (DFA) and Design for Test (DFT)
• Practical experience and knowledge of manufacturing processes, materials, and design requirements for: plastic, die casting, sheet metal, and machine parts.
• Tooling background/experience in molding, casting, machining, and metal forming.
• Good understanding of Microsoft tools (MS Project, Excel, Power Point, and Word). Mini Tab, CeTol, and DFM Analysis software is a plus.
• Six Sigma Certification Green Belt Certification preferred (Black Belt Certification a plus)
• Machining, casting, and Plastic injection molding experience a plus
• Practical experience with process qualification/validations e.g., IQ/OQ/PQ, Gage R&R
• Able to characterize and determine process capability using statistical analysis to determine Cpk/Ppk
• Proficient in performing Statistical analysis e.g., hypothesis testing, regression testing and use of DOEs for process characterization and optimization.
• Must be able to author engineering studies, protocols and reports.
• Experience programming PLCs and Graphical User Interfaces with various platforms and languages e.g., Ladder Logic, LabView, etc.

Key Requirements/Minimum Qualifications:

• Bachelor's degree in mechanical engineering or Biomechanical Engineering preferred.