Manufacturing Engineer
Company: NextPhase Medical Devices LLC
Location: Mansfield
Posted on: February 15, 2026
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Job Description:
Job Description Job Description Overview: 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, Process Flow Diagrams, Manufacturing Cells and Line
Layouts, Process Routers, Equipment Qualification and Process
Validation Protocols, Standard Operation Procedures and Work
Instructions. Responsibilities: • Design processes, specify
equipment, develop work instructions, perform validation (IQ, OQ,
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 considering 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 GMP, QSR
and ISO 9001 requirements. • Assist in pilot production of various
products. • Support production of products including ensuring
operators are properly trained, production schedule is adhered to,
and production paperwork is accurate. Work with production
personnel to identify improvement areas. • 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 recurrence. Qualifications: • 5 to 8
years of medical device manufacturing experience. • Knowledge of
design and fabrication of electro-mechanical components and
assemblies. • Experience using SolidWorks desirable. Experience
with 3-D solid modeling (e.g., SolidWorks, AutoCAD, ProEngineer)
required. • Proficient in Microsoft Office. • Working knowledge of
FDA GMP, QSR and ISO 13485 guidelines. • Ability to function
efficiently both independently and as a team member. • Motivated
individual able to work with minimal supervision. Education: • B.S.
Degree in Mechanical Engineering or Mechanical Engineering
Technology.
Keywords: NextPhase Medical Devices LLC, Pawtucket , Manufacturing Engineer, Engineering , Mansfield, Rhode Island
