Mechanical Engineer (Entry level)

We are seeking a Manufacturing Engineer II, NPI to support new product introduction, manufacturing process development, process validation, tooling, and production transfers within a medical device manufacturing environment. This position will work closely with Development and Manufacturing Engineering to define manufacturing requirements, prepare production processes, and support the transition of products into full production. Key Responsibilities Manufacturing Process Development Define and document component manufacturing requirements and processes Support manufacturing line readiness, including equipment, space, and staffing Write work instructions and train production staff Draft PFMEAs, process flow charts, and control plans Process Validation & Quality Perform process validation activities including IQ/OQ/PQ/MVP/TMV Support Gage R&R activities Finalize inspection procedures, sampling requirements, and inspection techniques Ensure accurate QMS/DMR records through the change order process Tooling & Manufacturing Transfer Maintain tooling documentation for production release using SolidWorks Update tool designs for manufacturability and create/modify tool drawings Ensure bill of materials and job router accuracy Monitor post-release transfers and identify process improvement opportunities Review process metrics to identify improvement opportunities Support manufacturing engineering projects through completion Participate in continuous improvement initiatives Provide feedback to improve the production transfer process Qualifications Bachelor’s Degree in a relevant Engineering discipline 3+ years of experience in a manufacturing environment Experience creating and modifying drawings and models using SolidWorks Experience with manufacturing process development and production transfer Experience with process validation and/or Gage R&R Strong communication and project management skills Ability to provide project updates and work with cross-functional teams Preferred Qualifications Medical device manufacturing experience Experience with IQ/OQ/PQ/MVP/TMV Experience with PFMEA, process flow charts, and control plans Experience with tooling design and manufacturability Experience with QMS/DMR documentation Experience supporting continuous improvement initiatives Compensation Pay Range: $35-$42/hr Location: Bethel, CT On-site Duration: 12 months Potential for extension or conversion #J-18808-Ljbffr