NextPhase Medical Devices LLC is a fast-growing, engineering design and contract manufacturer of single-use and electromechanical medical devices, with facilities in Rochester, NH, Mansfield, MA, Waldwick, NJ, and Tijuana, Mexico.

Based in our Mansfield, MA facility, the Manufacturing Engineer will work with other personnel to design, implement, and maintain manufacturing processes. The Manufacturing Engineer will be responsible for developing Process Failure Mode and Effects Analysis (PFMEA), Process Flow Diagrams, Manufacturing Cells and Line Layouts, Process Routers, Equipment Qualification and Process Validation Protocols, Standard Operation Procedures and Work Instructions.  The Manufacturing Engineer will work closely with all departments to efficiently transition products into manufacturing and also perform sustaining engineering work as needed.  Implement and maintain lean manufacturing principles, optimizing throughput, quality, and continuous improvement.

Duties/Responsibilities:

  • Design processes, specify equipment, develop work instructions, perform validation (IQ, 00, PQ), and train production personnel.
  • Develop, validate, and implement automated, semi-automated, and manual assembly and test equipment and tooling required for the production of disposable products. Ensure all equipment and tooling are properly documented and under calibration and preventative maintenance control as required.
  • Participate in FMEA activities to ensure process shortcomings are identified and appropriately addressed.
  • Work with Design Engineers and Quality Assurance to ensure that products are designed taking into consideration ease of manufacture and that the product will adhere to performance, cost, and quality requirements.
  • Coordinate with Quality Assurance and Research and Development to maintain an approved internal Quality System that meets the requirements of FDA QSR and ISO 13485.
  • Assist in pilot production of various products, developing lean manufacturing cells that optimize throughput and quality.
  • Support production of products including ensuring operators are properly trained, production schedule is adhered to and that production paperwork is accurate. Work with production personnel in identifying areas for improvement.
  • Continuously improve safety, quality, lead-time, productivity, and cost of existing manufacturing processes.
  • Identify root causes of manufacturing process nonconformities using NCMR and CAPA. Implement necessary actions to correct and prevent the recurrence of nonconformities.

Other Responsibilities:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Skills & Experience Required:

  • Knowledge of design and fabrication of electromechanical components and assemblies.
  • Experience using SolidWorks is desirable. Experience with 3-D solid modeling (e.g. SolidWorks, AutoCad. ProEngineer) is a must.
  • Proficient in Microsoft Office.
  • Working knowledge of FDA GMP, QSR, and ISO 13485 guidelines.
  • Function efficiently as both a team member and independently.
  • Requires a motivated individual that is able to work with minimal supervision.

Education & Experience Required:

  • B.S. Degree in Mechanical Engineering, Mechanical Engineering Technology, Manufacturing Engineering, or similar degree
  • 5 to 8 years of medical device manufacturing experience.
  • Medical device environment experience beneficial (ISO 13485 and FDA QSR)
  • Six Sigma Black Belt beneficial
  • Lean Certification beneficial

Physical Requirements:

  • Full range of motion for wrist, hand, and finger dexterity.
  • Sitting, working at a computer for long periods of time.

On-site/Remote Attendance:

This position requires 100% on-site attendance.