Sr Manufacturing Engineer (Perm)
Wilmington, MA 01810
Senior Advanced Manufacturing EngineerPERM
ESSENTIAL TASKS AND DUTIES INCLUDE:
• Manufacturing Engineering and Sustaining Engineering activities associated with the production of medical systems and products.
• Provide technical expertise and support related to existing and new manufacturing processes.
• Introducing new products and processes into production, including leading Process Development and Process Validation activities related to Disposable and Hardware production.
• Creation of Production Documentation including Manufacturing, Inspection and Test Instructions and submit for approval using document change order procedures.
• Creation of Assembly and Component Drawings to support manufacturing and sustaining engineering activities.
• Selection, design, installation and maintenance of Equipment, Tooling, and fixtures used in Production.
• Support Engineering team and Production team efforts to identify opportunities to streamline production through process improvements, test improvements, and product design changes.
• Work with Production Team, Quality Assurance and Design Engineering to identify and resolve technical and quality related issues including participation in MRB, customer complaint investigations, and CAPA related activities.
• Support continuous improvement project initiatives focused on improving product quality and reducing cost.
• Support Quality with activities related to quality and inspection procedures, incoming inspection methods, measurement system analysis (MSA), first article inspection (FAI), and gage repeatability and reproducibility (GR&R) activities.
• Support all facility related activities for maintaining the Production areas.
• Provide training for production and quality personnel for new and existing processes.
• Serve as strong team player, supporting and assisting supervisor and colleagues when necessary.
• Comply with all work safety rules and regulations.
BACKGROUND AND QUALIFICATIONS:
• Must have manufacturing engineering experience in an FDA/ISO regulated Medical Device/ Medical Equipment Industry.
• Must have prior Process Development and/or Manufacturing Engineering experience including the development and execution of Process Validation plans to support new and existing process and test equipment.
• Must have prior experience in the design and development of production fixtures and tooling.
• Ability to work with Solidworks, and/or Pro Engineer to create 3D models and drawings to support manufacturing assembly models, fixture design and development, and sustaining engineering activities.
• Experience with sustaining activities and product design activities a plus.
• Must have effective analytical and decision making skills, Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus.
• Experience using Minitab or similar statistical evaluation software/tools.
• Proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities.
• Must be detailed oriented with strong organizational skills and interpersonal skills with outstanding ability to communicate clearly and effectively.
• Must have ability to identify, prioritize, and resolve issues as they arise with minimal supervision.
• Maintain individual work area / equipment in a neat orderly manner according to standards including proper disposal of packaging waste, proper storage and use of equipment and parts, and management of documentation needed to perform duties.
• Must possess a strong work ethic, effective oral and written communication skills, and excellent interpersonal skills.
• BS in Engineering plus 3-10 years of experience working in an FDA/ISO regulated Medical Device/ Medical Equipment Industry, or equivalent education and years of experience.