Senior Injection Molding Engineer

To design new devices/components and make design changes or improvements to existing devices/components. Leads major molding programs to bring new designs or design changes through the applicable phases of the Product Development Process.

Essential Duties and Responsibilities:

• Functions as leader for major molding programs involving all phases of product design and development, leading Core Team through the execution of project activities
• Follows and improves the Product Development Process to ensure regulatory requirements are met and that the medical device meets the requirements for its intended use
• Plans and drives execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing production
• Applies the Risk Management Policy to the development process for identifying hazards, estimating and evaluating associated risks, controlling these risks and monitoring the effectiveness of risk controls
• Guides the project team through use of design and technology to drive innovation and significantly improve patient outcome
• Strives for improvement to ensure all applicable aspects of product design including design for manufacturability, scalability, testing, variability, and usability
• Sample molds and develop capable processes using scientific molding procedures
• Communicate and expedite corrections to tools or processes to ensure tool work or corrective actions are implemented accurately and in an efficient manner
• Oversees creation of detailed sub-assembly and final assembly drawings to serve as design specifications for a medical device
• Develops verification and validation plans for the protocols, test methods, and reports for execution of design verification and validation testing
• Able to navigate completely new medical devices through product requirements, design inputs, design outputs, and verification/validation in traceability matrix
• Introduces design mitigations to significantly reduce the risk profile for the medical device as documented in Risk Management File, dFMEA, and pFMEA (design/process Failure Mode Effects Analysis)
• Evaluates and designs products, parts, or processes for cost efficiency to minimize the cost for patient care
• Coordinates project activities for Commercial Release of molding products and corresponding manufacturing processes while meeting expectations for sustainable, efficient, repeatable, and reproducible manufacturing operations
• Leads Core Team to ensure that project phases are completed in a timely manner
• Defines activities for project execution to meet the requirements of the Product Development Process
• Supports request for quotes, specifically complex devices that vary greatly from predicates
• Upholds Spectrum Plastics Group vision and core values
• Follows all safety guidelines and adheres to safety absolutes

Qualifications: Knowledge, Skills, Education and Experience  

• Bachelor’s degree in engineering or equivalent experience in a related field.
• 10+ years injection molding experience
• Proficient in commonly-used concepts, practices, and procedures within medical device design and development
• Experience as project manager on a project which involved all phases of product design and development, leading Core Team through the execution of project activities
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