Manufacturing Engineer (Warsaw)

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.