JOB PURPOSE To design new devices/components and make design changes or improvements to existing devices/components. Leads or is a team member on projects to bring new designs or design changes through the applicable phases of the Product Development Process.

ESSENTIAL DUTIES • Functions as leader or team member for projects involving all phases of product design and development, leading Core Team through the execution of project activities • 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 • Optimizes design and technology to drive innovation and significantly improve patient outcome • Ensures all applicable aspects of product design including design for manufacturability, scalability, testing, variability, and usability • Diligently develops product requirements and design inputs based on the applicable standards as well as other relevant sources, such as Post-Market Surveillance • Oversees and participates in creation of 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 • Verifies connection between product requirements, design inputs, design outputs, and verification/validation is clear in traceability matrix • Leads and ensures thoroughness of risk management activities 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 product and corresponding manufacturing processes while meeting expectations for sustainable, efficient, repeatable, and reproducible manufacturing operations • Defines activities for project execution to meet the requirements of the Product Development Process • Supports requests for quotes by outlining necessary project activities and timing for new product introduction • Upholds Spectrum Plastics Group vision and core values • Follows all safety guidelines and adheres to safety absolutes

NOTE: This job description is not intended to be an exhaustive list of all possible duties, responsibilities and or qualifications. Other duties, responsibilities and/or qualifications may be assigned to this position.

Qualifications

QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities) Required • Bachelor’s degree in engineering or equivalent experience in a related field. • 3-7 years industry experience • 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 provide guidelines and instructions applicable to the job function • 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

Preferred • Master’s degree in engineering discipline • 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 • Has knowledge of commonly used concepts, practices, and procedures within medical device design and development • Can handle financial responsibilities for project such as budget accountability and revenue recognition • Experience developing Gantt Charts in Microsoft Project • Demonstrated ability to complete product design transfers

WORKING CONDITIONS Works with supervision from manager as necessary. Requires light physical activity performing non-strenuous daily activities.