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New Product Development Engineer
2 months ago
Summary:
Provide Technical assistants to New Component Development including Silicone, Plastic and Value Added projects.
Assists the Tech Center Manager to ensure technical and operational systems, efficiencies, schedules, and quality requirements are met or exceeded.
Assures project outcomes are fully transferable to manufacturing and perform well for up to one year.
Principal Duties and Responsibilities Include:
Project management for a variety of projects at ProMed, including new technology, capital equipment purchases, and new product/project development.
Project planning.
Project status.
Project execution.
Customer Communication.
Develop and troubleshoot processes including but not limited to Material Preparation, Insert Preparation and Priming, Set-up, Trim, Wash, Post Cure, Assembly, and Measurement.
Assists in designing of fixtures and tooling to facilitate product development.
Process Writing, Documentation Packet creation and Release Packet creation.
Write Validation and Qualification project reports when needed for each new component that transfers to production.
Perform investigation of root cause analysis and implement corrective action as it pertains to customer complaints and internal non-conformances.
Identify and/or resolve dimensional characterization methodology and inspection criteria issues.
Qualify/Validate processes and/or equipment to meet customer and ProMed objectives.
Implement and support Research and Development initiatives related to new technology and release of new production components.
Assist in the engineering of projects consisting of process development, associated fixture(s) and generation of manufacturing documentation to meet quality objectives.
Report project status related to technical challenges, including quality concerns, and schedule compliance.
Aid in the integration of projects into production, encompassing the following elements: Tooling, Product, Process, Equipment Qualifications, Training of Manufacturing Personnel, and release of a manufacturing documentation package.
This results in the transfer of a project from an engineering status to manufacturing approved status.
Perform other duties as required.
Preferred Education/Experience (or will train):
Knowledge/Training to ISO 13485(current), Medical Devices QM System.
Knowledge/Training to ISO 14971(current), Risk Management.
Engineering degree with a medical device-related background or equivalent and a minimum of five years experience related to a manufacturing/process development environment.
Experience managing multi-discipline teams and projects a plus.
Good communication and problem-solving skills with the ability to coordinate customer needs and production capabilities.
Proficient in PC, Word Processing, Microsoft Office, Spreadsheets, Blue Print Reading, SPC, SQCpack, and design of methodology.
Knowledge/Training of Micro Vu, Comparator, and/or equivalent.
Preferred Qualifications (or will train):
Ability to design and qualify tooling, fixtures and processes used to produce Silicone, Plastic, and Value Added molded components, and Assemblies for medical devices.
Demonstrated communications skills for making persuasive presentations to peers, subordinates, management, and customers.
Capable of identifying and implementing innovative technical solutions for Priming, Silicone Molding, and Bonding/Assembly of various substrates, in support of multiple engineering and manufacturing initiatives.
Strong knowledge and first-hand experience in the processing and assembly of Silicone and Plastic components consumed within the medical device industry.
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