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Manufacturing Process Engineer II

2 months ago

Waltham, United States Nova Biomedical Full time

Nova Biomedical is hiring a Manufacturing Process Engineer II on-site in our Waltham, MA facility. This individual will support the daily technical activities of planar sensor manufacturing. This includes developing and optimizing manufacturing processes to achieve increased output, quality, and cost goals of the organization. Collect and production data and apply statistical methods to analyze, document, and diagram production processes and process improvements. The individual will also contribute to the investigation of technical issues within the area of support. Other responsibilities include : Providing day-to-day technical floor support to planar sensor operations by investigating and resolving issues which arise during the manufacturing/processing of products. Measuring/inspecting components for form, fit, function and disposition nonconforming product as required. Documenting via Manufacturing Variance or Engineering Change Orders and variances/changes and circulate for approval. Updating/creating all forms of manufacturing documentation (AP, TP, OI, OP, Drawings and Artwork) which conform to Quality System Regulations (QSR's) and ISO standards. Writing and/or executing Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validations, Design of Experiment (DOE), Process Failure Mode Effects Analysis (PFMEA), Process Validation Master Plans and Continuous Improvement Studies/Evaluations. Researching, specifying, and procuring new equipment for existing or new processes/assemblies. Designing and constructing tooling/fixtures for processes or modify existing production equipment as needed. Collaborating with R&D and other manufacturing engineers to develop methods/processes to scale production and implement new products. Training assemblers and operators regarding new processes and assemblies. Leading continuous improvement programs to reduce cost and cycle times of products. Examining and implementing lean manufacturing techniques. Working cross-functionally with Consumable Engineering for automation and longer-term projects as appropriate. Qualifications: Physical Requirements: Hearing. Remaining in a stationary position, often standing or sitting for prolonged periods. Ability to wear PPE. Ability to travel. Knowledge of lean manufacturing methods and practices. Six Sigma Green Belt (Preferred). Skills/Competencies: Strong interpersonal and communication skills. Strong Project Management Fundamentals. Time Management skills. Six Sigma. Lean Manufacturing Principles. Minitab (Other statistical and graphical analysis applications). Education/Experience: B.S. in Mechanical Engineering or Industrial Engineering is required. 2-4 years of experience in an ISO 13485 environment is required. #J-18808-Ljbffr