Senior Injection Molding Engineer

Spectrum Plastics Group•Sandy, UT

About The Position

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.

Requirements

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

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