Senior Advanced Manufacturing Engineer

JOB DESCRIPTION

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. 

EDUCATION:

•    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. 

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