Manufacturing Engineer I

Job Summary The Manufacturing Engineer I will be responsible for the selection, development, qualification, and scale‑up of production processes and equipment across different manufacturing departments. Process objectives are the high quality, high volume production of patient‑tailored implants and associated instruments. Duties and Responsibilities Develop and maintain strong, internal working relationships across restor3d. Understand the objectives, responsibilities, and mission of the Operations department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Initiation, execution, and documentation of IQ, OQ, and PQ activities. Optimization of manufacturing processes (5S) for Lean Manufacturing. Development of formal training programs for the production personnel. Day‑to‑day production support activities such as NCRs and CAPAs. Processing of engineering change orders from originator to final approval. Developing and updating preventative maintenance programs. Writing and executing process validation plans and reports, using sound, data‑/stats‑supported results. Play a major role in the CNC process for the manufacturing of implants. Using statistical tools for alternative material evaluations and validation projects. Support of material handling and control system. Conduct time studies and process flow mapping. Assure compliance with the requirements set forth by US FDA QSR and ISO regulations. Documentation of manufacturing processes and inspection criteria within the company’s documentation procedures. Evaluate and recommend capital equipment to best suit needs of company’s selected fabrication processes. Participation on project teams as a key contributor bringing proactive solutions and execution. Other responsibilities as assigned. Required Education and Experience 1‑3 years of experience in manufacturing process support and development in the medical device industry. Bachelor’s Degree in Engineering required. Preferred Education and Experience Previous experience in orthopedics strongly preferred. Previous experience working with CNC machines preferred. Medical Device/GMP experience preferred. Required Skills Excellent written and verbal communication skills. Able to work accurately in a medical device regulated environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy and thoroughness. Strong organizational, analytical and time‑management skills. Able to self‑motivate and work both independently and as part of a team. Understanding of ISO 13485 and QSR regulations. Knowledge of statistical analysis (Green Belt preferred). Experience working with CNC manufacturing processes. Knowledge of computer aided design (SolidWorks preferred). Physical Requirements Working at a desk for prolonged periods of time. Working with CNC machines/equipment. #J-18808-Ljbffr Page Mechanical Group, Inc.