{"schemaVersion":"jobsearcher.job.v1","id":"bb66efd2d14c2121d25ff480","url":"https://jobsearcher.com/jobs/bb66efd2d14c2121d25ff480","canonicalUrl":"https://jobsearcher.com/jobs/bb66efd2d14c2121d25ff480","title":"Design Engineer","description":"Job Summary\n\nA key member of the product development team, the Design Engineer develops both new product design and design changes, leading engineering tasks and support through production. A focus on creative design solutions to meet product requirements using resources such as CAD tools and analysis techniques coupled with an understanding of materials, manufacturing processes, tool design, and cost of production. An additional focus is to ensure technical documentation is completed to fulfill the requirements of the design history file, following established design controls to meet medical product regulatory compliance requirements.\n\nEssential Functions\n\nJob Responsibilities\n\nDevelop design solutions to meet defined product requirements within a regulated medical device industry.\nLead engineering input through new product development and design changes.\nCreate, refine, and manage complex 3D product solid models using SolidWorks.\nProduce detailed drawings for production specifications.\nOrganize and maintain accurate documentation, design data, and digital records for design history files in accordance with ISO 13485 and FDA (21 CFR Part 820) standards.\nPrepare technical documentation such as BOM, work instructions, test plans, test reports, risk analysis, labeling, product acceptance criteria, and design reviews.\nContribute to cross-functional new product development teams, supporting design, validation, and release to production.\nAssemble prototypes and production samples for verification and validation to confirm product meets requirements and standards.\nOptimize designs for manufacturability, cost efficiency, and reliability.\nPlan, prioritize, and coordinate work activities to meet project deadlines and deliverables.\nStay current on emerging medical device technologies, materials, and regulatory trends to support organizational goals.\nEnsure and follow safety requirements and standards.\nAdhere to Company’s Quality Management System requirements.\nMaintain a safe, neat, and orderly work environment.\nPerform all duties in a manner that follows, demonstrates, and promotes Company’s values.\nReport to work as scheduled, on time, and able to work entire work schedule.\nPerform additional duties as assigned.\nKnowledge, Skills, and Ability\nKnowledge of medical device regulations (ISO 13485) and quality systems.\nAbility to leverage creativity and resourcefulness in applying design concepts through development to production.\nProduct design skills and mechanical aptitude with a working knowledge of component manufacturing processes for both metals and plastics.\nAbility to develop and carry out testing to verify and validate designs.\nAbility to apply analytical techniques to design and risk analysis, such as DFMEA.\nStrong proficiency in 3D CAD design and modeling, with expertise in SolidWorks.\nStrong drafting proficiency, including dimensioning and tolerancing (GD&T).\nProficiency in Microsoft Office Suite and digital file management.\nOrganized and detail oriented, with solid technical writing skills.\nTeam oriented with the ability to lead engineering effectively in a cross-functional team environment.\nAbility to work effectively both independently and within a team environment.\nAbility to effectively present information and respond to questions in meetings and design reviews.\nPossess a continuous improvement mindset.\nPossess effective written and oral communication skills.\nAbility to be highly adaptable and responsive to changing business needs.\nIntermediate math proficiency.\nAbility to obtain a passport if needed for international travel.\nAbility to observe and identify details.\nAbility to effectively communicate and perceive information.\nAbility to work extended hours as scheduled, including weekends.\nPhysical Demands\nFrequent sitting, wrist manipulation, walking, and standing.\nFrequent sedentary work with lifting up to 10 pounds.\nOccasional medium work with lifting up to 40 pounds.\nManual dexterity to type and operate office equipment occasionally.\nManual dexterity to use hand tools for assembly and measuring.\nMust be able to complete all physical requirements to perform the essential functions.\nQualifications\n\nEducation/Education\nBachelor degree in Mechanical Engineering or related Engineering Technology degree, or 1-3 years of related experience.\nExperience in CAD environment with preference of 3+ years’ experience in mechanical design.\n1-3 years of experience in the medical device industry (Class I) preferred.\nWorking Environment\nStandard working conditions include a temperature-controlled office environment and manufacturing environment.\nPosition may include occasional domestic and international travel up to 10%.\n\nThis position does not now or in the future provide immigration sponsorship.\n\nThis position is subject to a background check. A prior conviction or pending charge will not automatically disqualify you from consideration. In accordance with the Fair Credit Reporting Act and Wisconsin Fair Employment Act, criminal histories will only be evaluated if the circumstances of the offense substantially relate to the duties of this position.\n\nThis job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the associate for this position. Duties, activities, and responsibilities may change, or new ones may be assigned at any time with or without notice. Associate must be able to satisfactorily perform the essential functions of the position with or without reasonable accommodation.\n\nKi Mobility is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.","company":"Ki Mobility","rawCompany":"ki mobility","city":"Stevens Point","state":"WI","isRemote":false,"isActive":false,"createdAt":"2026-04-12T18:55:47.719Z","occupations":[{"code":"17-2141.00","title":"Mechanical Engineers","slug":"mechanical-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"17-3013.00","title":"Mechanical Drafters","slug":"mechanical-drafters"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"541420","title":"Industrial Design Services","slug":"industrial-design-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Design Engineer","description":"Job Summary\n\nA key member of the product development team, the Design Engineer develops both new product design and design changes, leading engineering tasks and support through production. A focus on creative design solutions to meet product requirements using resources such as CAD tools and analysis techniques coupled with an understanding of materials, manufacturing processes, tool design, and cost of production. An additional focus is to ensure technical documentation is completed to fulfill the requirements of the design history file, following established design controls to meet medical product regulatory compliance requirements.\n\nEssential Functions\n\nJob Responsibilities\n\nDevelop design solutions to meet defined product requirements within a regulated medical device industry.\nLead engineering input through new product development and design changes.\nCreate, refine, and manage complex 3D product solid models using SolidWorks.\nProduce detailed drawings for production specifications.\nOrganize and maintain accurate documentation, design data, and digital records for design history files in accordance with ISO 13485 and FDA (21 CFR Part 820) standards.\nPrepare technical documentation such as BOM, work instructions, test plans, test reports, risk analysis, labeling, product acceptance criteria, and design reviews.\nContribute to cross-functional new product development teams, supporting design, validation, and release to production.\nAssemble prototypes and production samples for verification and validation to confirm product meets requirements and standards.\nOptimize designs for manufacturability, cost efficiency, and reliability.\nPlan, prioritize, and coordinate work activities to meet project deadlines and deliverables.\nStay current on emerging medical device technologies, materials, and regulatory trends to support organizational goals.\nEnsure and follow safety requirements and standards.\nAdhere to Company’s Quality Management System requirements.\nMaintain a safe, neat, and orderly work environment.\nPerform all duties in a manner that follows, demonstrates, and promotes Company’s values.\nReport to work as scheduled, on time, and able to work entire work schedule.\nPerform additional duties as assigned.\nKnowledge, Skills, and Ability\nKnowledge of medical device regulations (ISO 13485) and quality systems.\nAbility to leverage creativity and resourcefulness in applying design concepts through development to production.\nProduct design skills and mechanical aptitude with a working knowledge of component manufacturing processes for both metals and plastics.\nAbility to develop and carry out testing to verify and validate designs.\nAbility to apply analytical techniques to design and risk analysis, such as DFMEA.\nStrong proficiency in 3D CAD design and modeling, with expertise in SolidWorks.\nStrong drafting proficiency, including dimensioning and tolerancing (GD&T).\nProficiency in Microsoft Office Suite and digital file management.\nOrganized and detail oriented, with solid technical writing skills.\nTeam oriented with the ability to lead engineering effectively in a cross-functional team environment.\nAbility to work effectively both independently and within a team environment.\nAbility to effectively present information and respond to questions in meetings and design reviews.\nPossess a continuous improvement mindset.\nPossess effective written and oral communication skills.\nAbility to be highly adaptable and responsive to changing business needs.\nIntermediate math proficiency.\nAbility to obtain a passport if needed for international travel.\nAbility to observe and identify details.\nAbility to effectively communicate and perceive information.\nAbility to work extended hours as scheduled, including weekends.\nPhysical Demands\nFrequent sitting, wrist manipulation, walking, and standing.\nFrequent sedentary work with lifting up to 10 pounds.\nOccasional medium work with lifting up to 40 pounds.\nManual dexterity to type and operate office equipment occasionally.\nManual dexterity to use hand tools for assembly and measuring.\nMust be able to complete all physical requirements to perform the essential functions.\nQualifications\n\nEducation/Education\nBachelor degree in Mechanical Engineering or related Engineering Technology degree, or 1-3 years of related experience.\nExperience in CAD environment with preference of 3+ years’ experience in mechanical design.\n1-3 years of experience in the medical device industry (Class I) preferred.\nWorking Environment\nStandard working conditions include a temperature-controlled office environment and manufacturing environment.\nPosition may include occasional domestic and international travel up to 10%.\n\nThis position does not now or in the future provide immigration sponsorship.\n\nThis position is subject to a background check. A prior conviction or pending charge will not automatically disqualify you from consideration. In accordance with the Fair Credit Reporting Act and Wisconsin Fair Employment Act, criminal histories will only be evaluated if the circumstances of the offense substantially relate to the duties of this position.\n\nThis job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the associate for this position. Duties, activities, and responsibilities may change, or new ones may be assigned at any time with or without notice. Associate must be able to satisfactorily perform the essential functions of the position with or without reasonable accommodation.\n\nKi Mobility is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.","datePosted":"2026-04-12T18:55:47.719Z","dateModified":"2026-04-12T18:55:47.719Z","hiringOrganization":{"@type":"Organization","name":"Ki Mobility","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Stevens Point","addressRegion":"WI","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"bb66efd2d14c2121d25ff480"},"url":"https://jobsearcher.com/jobs/bb66efd2d14c2121d25ff480"}}