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Spectrum Plastics Group, A DuPont Business · 3 months ago

Senior Injection Molding Engineer

Sandy, UT

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

Spectrum Plastics Group, A DuPont Business is seeking a Senior Injection Molding Engineer to design new devices and improve existing ones. The role involves leading major molding programs and ensuring compliance with regulatory requirements throughout the product development process.

ManufacturingMedical DevicePlastics and Rubber Manufacturing

H1B Sponsor Likely

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

Qualification

Injection molding experienceMedical device designISO 13485 knowledgeProject managementRisk managementDesign for manufacturabilityVerificationValidationFinancial accountabilityProficient computer skillsCommunication skillsAttention to detailTeamworkProblem solving

Required

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

Knowledge on developing full-scale project plans

Effectively communicated project expectations to team members and stakeholders in a timely and clear fashion

Experience planning and driving execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing production

Can handle financial responsibilities for major programs, such as budget accountability and revenue recognition

Demonstrated history to problem solve, identify errors and deficiencies and perform research

High degree of understanding of ISO 13485 requirements for Design Controls

Ability to apply knowledge to their job function using pre-established guidelines and instructions

Accuracy, attention to detail, and thoroughness

Proficient computer skills

Proficient communications skills

Ability to comprehend and comply with company safety and quality standards

Ability to provide oral and written instructions to others

Company

Spectrum Plastics Group, A DuPont Business

Acquired in August 2023 by DuPont, Spectrum’s history spans over 60 years of applications expertise including precision extrusion, specialty injection molding, blown film extrusion and conversion, medical balloon fabrication, laser processing, additive manufacturing, and complex assembly of catheters and other devices.

Founded in 1961

Alpharetta, Georgia, USA

1001-5000 employees

https://www.spectrumplastics.com/

H1B Sponsorship

Spectrum Plastics Group, A DuPont Business has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2024 (1)