MFG & PROCESS DVL ENGINEER II

Job Overview

Provides guidance and leadership on manufacturing processes in order to support organizational manufacturing goals; performs research on products and manufacturing process and share the same with senior engineers.

Job Requirements

• Developing production improvement goals; recommending suggestions for improvements to management.
• Evaluating unfinished products and components; recommends quality and production improvements.
• Analyzing statistics related to production efficiency, safety measures, and resource usage; research on effective ways of research with regards to cost saving.
• Designing and evaluates plans for implementing manufacturing equipment, technology and resources to meet goals.

What your background should look like

Key Responsibilities:

• New Product/Process Development
• Execute process and test method validation along with design, develop, and qualify tooling/equipment
• Using problem solving and DMAIC tools to solve processes and process improvements
• New Product Introductions
• Manage product transfers from new product development to operations or product transfers from site to site.  
• Develop bills of materials and assembly methods documentation while providing any training needed to technicians and assemblers.
• Team Leadership (Primary)
• An effective communicator that prepares status reports, modifies schedules, and manages project plans.  
• Communicate to stakeholders, customers, and others informed of project status and/or related issues
• Ability to coordinate a team of engineers and technicians and direct technical work
• Coach/mentor technical topics to junior engineers and technicians during product transfers
• Collaborate effectively with other departments, including Quality, R&D, NPD, and Operations.
• Project Management (Supporting)
• Manage your project timelines and resources effectively.
• Work with cross functional teams while being self-driven
• Manage activities with risk to the project timelines, developing contingency plans, while outlining deliverables and milestones
• Quality, Safety and Regulatory Compliance (Supporting)
• Work with Quality Team to ensure all manufacturing processes and equipment comply with FDA regulations, ISO standards, and other relevant industry guidelines
• Comply with safety and security procedures and report potentially unsafe conditions when using equipment and materials properly
• Manage design requirements like Bioburden or Particulates, Biocompatibility and Cleanroom Environment compatibility

Required Skills & Experience

• Bachelor's degree in Engineering, Plastics, Chemical, Biomedical or Mechanical Engineering preferred
• 4+ years of working experience in the Medical Device Industry
• 2+ years of working experience in new production development or product transfers
• Thorough understanding of Quality Management Systems (QMS) requirements that involve:
• Process Mapping
• Manufacturing Process Instructions
• DOE and Process Characterization
• OQ/PQ Protocol and Reports
• IQ/OQ Protocols and Reports
• PFMEAs
• MVP/MVRs.
• Experience in technically leading a team of engineers and technicians across multiple projects
• Medical Device New Product Development which includes process development and characterization along with equipment/fixture design and qualification and test method and process validations
• Preferred Skills & Experience
• Hands-on experience with complex steerable or multi-lumen catheter assembly development and manufacturing with that includes manufacturing technologies with mandrel design, PTFE assembly, reflow, braiding,
• tipping and extrusion
• Experience with design controls, FDA regulation, GMP practices, and QSR requirements
• CAD proficiency - SolidWorks and Mastercam
• MS Office proficiency  
• Ability to achieve goals with effective planning and prioritization skills to meet immediate and long-range needs with independence
• Must be well-organized, detail-oriented, with excellent oral and written communication skill
• Green Belt (desirable)
• American Visa (desirable)

Competencies