Manufacturing Engineer

We are hiring for Manufacturing Engineer in Warsaw, IN.

Position Overview: The Manufacturing Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures throughout the product lifecycle - from design through production. The role works to obtain critical information for product process development. The Staff Manufacturing Engineer also collaborates with Production, Quality, and R&D teams to support manufacturing operations and product launch timelines.

Essential Job Functions

• Collaborative with R&D, QA and Production departments to design, develop, test, document, and implement manufacturing processes, tooling, and fixtures.
• Design and develop manufacturing processes in compliance with the company’s Design Control and applicable regulatory requirements.
• Collect and analyze data on process performance and capabilities for both new and existing products.
• Prototype and develop proof-of-concept designs and bench models to test concepts in simulated environments.
• Develop, validate, and maintain test methods.
• Perform tolerance analysis for components, materials, packaging, and supplies used in-house processing.
• Lead the development and maintenance of process Failure Modes and Effects Analyses (pFMEAs).
• Prepare user requirements, technical specifications, and design specifications.
• Identify process needs, support operations management, and implement required equipment and fixturing development and manufacturing.
• Develop and maintain documentation in support of design control, product configurations, manufacturing procedures, lot history records, (e.g., bills of materials, MPI’s, LHR’s), and other Quality System requirements.
• Evaluate existing engineering processes and implements process improvements.
• Lead or actively participate in product/process engineering problem-solving using DMAIC methodology.
• Lead or support process and product improvement projects in collaboration with production, R&D engineers and technicians.
• Assist Procurement and R&D departments with supplier selection and technical development.
• Recommend and evaluate new technologies to improve system performance and reliability.
• Conduct productivity and cost analyses, including direct labor, time studies& materials cost estimates, offering solutions to improve efficiency and scalability.
• Create a stability matrix in Phase 4 to assess the sustainability of product transfer. Sustaining Engineering will maintain sustainability, with support from the Staff Manufacturing Engineer.
• Identify cost-reduction opportunities and implement savings strategies for existing products.
• Support the product line transfers and qualification/validation efforts.
• Perform other duties as assigned. These responsibilities are not intended to be an exhaustive list of all duties and skills required.

Requirements

• Bachelor’s degree in Manufacturing Engineering, Manufacturing Engineering Technology, Mechanical Engineering Technology or equivalent
• 0-5 years experience in a manufacturing environment, medical device highly preferred
• 2+ years of CNC machining experience highly preferred, ability to program would be ideal
• Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
• Knowledge of and compliance with applicable Quality System requirements including QSRs, FDA, ISO, MDD and other relevant regulations.
• Experience with process validations (IQ, OQ, PQ), 6S, Lean Manufacturing principles.
• Proficiency in applying statistics and using statistical software, including conducting capability studies (Cpk’s), and analyzing design of experiences (DOE).
• Experience with software such as:
  Solidworks, Minitab or similar tools.