Manufacturing Engineer

Company: DOTS Technology Corp
Location: Natick
Posted on: August 7, 2022

Job Description:

About the Role We are looking to hire a Manufacturing Engineer who is excited about joining a fast-paced team creating a life changing product for consumers. You will utilize your experience in a dynamic startup environment as a member of our Operations team. You will work in deep collaboration with the Operations, Engineering, Quality, Project Management, and Science functions to efficiently manufacture our products within DOTS' manufacturing operation and with our contract manufacturing supply base. -Who You Are -You are a highly collaborative engineer that has successfully launched products. Using your experience, you work seamlessly between DOTS, equipment suppliers, and external manufacturing teams to introduce new manufacturing lines, scale up production, increase capacity, improve efficiencies, and reduce total costs. You are intellectually curious and seek out and implement creative solutions to fix problems. You also have led automation projects and are familiar with smart factory concepts, ie IoT integration in operations, data collection and analytics, and robotics and machine learning. -Primary Responsibilities/Accountabilities:

• Develops, maintains and improves manufacturing procedures, documentation, tools, fixtures, equipment, and manufacturing lines on all DOTS' products
• In collaboration with Engineering, Quality, and Science, responsible for planning, designing, developing, and maintaining Work Instructions and Test Procedures for internal or contract manufacturing operations.
• Collaborates with internal and contract manufacturing to ensure all staff receive training to effectively build the product and verify the product's performance to specification.
• Work closely with internal and contract manufacturers and sub-tier suppliers to design and qualify high capability processes using process risk assessments (pFMEA), process flows, control plans, process validations (IQ, OQ, PQ), and product acceptance criteria.
• Responsible for leading manufacturing product improvement programs, including Productivity, Manufacturability, VA/VE, Quality, and Reliability projects.
• Lead VA/VE as a systematic process to creatively assess and generate alternatives to essential functions that provide the greatest value.
• Lead and implement data-driven improvements within the manufacturing operation for product design, assembly processes, and supply chain management.
• Identify the root cause of manufacturing process and product nonconformities. Identify and implement necessary actions to correct and prevent recurrence though the corrective and preventative action process.
• Initiate and/or approve all necessary changes in product design, tooling, methods, processes and any documentation that affects the manufacturability of an item or process, including Process Validation protocols.
• Local and International travel is required. Ability to travel up to 50% of the time.
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations. -Minimum Educational Level:
  • Bachelor's Degree in Electrical Engineering, Mechanical Engineering or similar engineering discipline or related technical field.
  • Masters degree is preferred. -Required Skills and Experience:
    • years of relevant experience with Bachelors Degree OR 2+ years of relevant experience with Masters Degree
    • Understanding of Lean Manufacturing and Six Sigma, certification preferred (Green Belt, Black Belt).
    • Experience in high-volume manufacturing, preferably with diagnostic and/or medical device products in an ISO certified Quality Management System.
    • A self-motivated team player with excellent verbal and written communications skills. Must be able to convey business and technical concepts to diverse stakeholders and technical teams in a clear and concise manner.
    • Ability to work independently and communicate with a vast network of global stakeholders.
    • Strong understanding of Master Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification.
    • Must enjoy a fast paced, dynamic environment and an inherent nature to solve complex problems.
    • Proficient with managing and understanding cross-cultural business practices.
    • Experience performing in a fast-paced and time-sensitive environment.
    • Ability to work independently with minimal supervision on a daily basis. -Nice to Have Skills and Experience:
      • Demonstrated working knowledge of ISO 13485.
      • Experience in Statistical methodologies; DOE, SPC, etc.
      • Experience with CAD systems: SolidWorks (or equivalent), Electrical Simulation Tools.
      • Experience with process development, verification, and validation and component / material qualification and acceptance testing.
      • Experience with risk management, including Process Failure Mode Effects Analysis (pFMEA), Design Failure Mode Effects Analysis (dFMEA), fault tree analysis, or other risk management tools.
      • Experience in Windows applications including Microsoft Office.
        

Keywords: DOTS Technology Corp, Boston , Manufacturing Engineer, Engineering , Natick, Massachusetts