JOB PURPOSE: To design new devices/components and make design changes or improvements to existing devices/components. Leads major programs to bring new designs or design changes through the applicable phases of the Product Development Process. ESSENTIAL DUTIES: + Functions as leader for major 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 + Diligently develops product requirements and design inputs based on the applicable standards as well as other relevant sources, such as Post-Market Surveillance + 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 expansive product lines 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 QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities) Required: + Bachelor’s degree in engineering or equivalent experience in a related field. + 7+ years industry 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 Preferred: + Master’s Degree in Engineering discipline + Proficiency in Microsoft Project + Demonstrated ability to complete product design transfers + Knowledge of applicable standards for EtO sterilization (e.g. ANSI/AAMI/ISO 11135-1, ANSI/AAMI/ISO 11135-2) WORKING CONDITIONS: Works with minimal supervision from manager . Requires light physical activity performing non-strenuous daily activities