We are seeking a Process Manufacturing Engineer to support process engineering, manufacturing engineering, quality, equipment calibration, in-process monitoring, validation, and yield/scale-up activities within a regulated medical device manufacturing environment. The ideal candidate is an execution-oriented engineer with hands-on experience developing and improving manufacturing processes, executing validations, and using data/statistical methods to drive process improvements. Responsibilities Support process engineering and manufacturing engineering activities for medical device manufacturing operations. Develop, improve, and optimize manufacturing processes to improve yield, quality, throughput, and process consistency . Support process development, scale-up, and technology transfer activities. Plan and execute test method validation (TMV) activities, including protocols, sample creation, test execution, data analysis, and final documentation. Support process validation activities, including validation planning, protocol development, execution, and reporting. Perform in-process monitoring and analyze manufacturing data to identify trends, variation, and opportunities for improvement. Support equipment calibration and ensure manufacturing equipment remains within required specifications. Apply DOE, statistical analysis, and Minitab to evaluate process performance and support engineering decisions. Develop, revise, and implement SOPs, work instructions, validation plans, and engineering documentation . Partner with Quality, Manufacturing, R&D, and Operations teams to resolve process and product-related issues. Lead or support engineering projects from planning through implementation and documentation. Ensure engineering activities comply with applicable FDA and medical device quality requirements . Required Qualifications 3-4+ years of engineering experience , preferably in medical device manufacturing or another highly regulated industry. Bachelor's degree in Mechanical, Chemical, Biomedical, Manufacturing, or related Engineering discipline . Experience working in a regulated manufacturing environment ; medical device experience strongly preferred. Hands-on experience with Test Method Validation , including protocols, sample creation, execution, data analysis, and documentation. Experience with process validation and manufacturing process development/improvement. Working knowledge of DOE, statistics, and Minitab or similar statistical analysis tools. Strong understanding of manufacturing processes, quality systems, and engineering documentation. Ability to work independently and execute projects rather than providing consulting-only support. Preferred Qualifications Medical device manufacturing experience. Experience with yield improvement and process scale-up . Experience developing and driving SOPs and validation plans . Project leadership or technical lead experience. Experience working cross-functionally with Quality, R&D, Manufacturing, and Operations teams. Experience with equipment qualification, calibration, and process monitoring. Key Skills Process Engineering | Manufacturing Engineering | Medical Devices | Test Method Validation | Process Validation | DOE | Minitab | Statistics | Equipment Calibration | In-Process Monitoring | Yield Improvement | Scale-Up | SOPs | Validation Plans |

Quality Systems Pay:

$50.00 - $55.00 per hour

Experience:

Medical devices

Industry:

5 years (Preferred) Test method validation: 5 years (Preferred)

Work Location:

In person