Product Development Engineer III

JOB PURPOSE: To design new devicescomponents and make design changes or improvements to existing devicescomponents. 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 activitiesFollows and improves the Product Development Process to ensure regulatory requirements are met and that the medical device meets the requirements for its intended usePlans and drives execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing productionApplies 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 controlsGuides the project team through use of design and technology to drive innovation and significantly improve patient outcomeStrives for improvement to ensure all applicable aspects of product design including design for manufacturability, scalability, testing, variability, and usabilityDiligently 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 deviceDevelops 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 verificationvalidation 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 (designprocess 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 operationsLeads Core Team to ensure that project phases are completed in a timely mannerDefines activities for project execution to meet the requirements of the Product Development Process Supports request for quotes, specifically complex devices that vary greatly from predicatesUpholds Spectrum Plastics Group vision and core valuesFollows all safety guidelines and adheres to safety absolutesQUALIFICATIONS (EducationExperienceKnowledge, Skills & Abilities)Required:Bachelor's degree in engineering or equivalent experience in a related field. 7+ years industry experienceProficient in commonly-used concepts, practices, and procedures within medical device design and developmentExperience as project manager on a project which involved all phases of product design and development, leading Core Team through the execution of project activitiesKnowledge on developing full-scale project plans Effectively communicated project expectations to team members and stakeholders in a timely and clear fashionExperience planning and driving execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing productionCan handle financial responsibilities for major programs, such as budget accountability and revenue recognitionDemonstrated 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 instructionsAccuracy, attention to detail, and thoroughnessProficient computer skills Proficient communications skillsAbility to comprehend and comply with company safety and quality standardsAbility to provide oral and written instructions to othersPreferred:Master's Degree in Engineering disciplineProficiency in Microsoft ProjectDemonstrated ability to complete product design transfersKnowledge of applicable standards for EtO sterilization (e.g. ANSIAAMIISO 11135-1, ANSIAAMIISO 11135-2)WORKING CONDITIONS: Works with minimal supervision from manager. Requires light physical activity performing non-strenuous daily activitiesNOTE: This job description is not intended to be an exhaustive list of all possible duties, responsibilities and or qualifications. Other duties, responsibilities andor qualifications may be assigned to this position.

Created: 2025-02-21