Konik
Project Engineer
Konik, Saint Paul, Minnesota, United States, 55199
Project Engineer - SustainingContract-to-Hire or Direct Hire | Saint Paul, MN | $80k-115k
Konik is partnering with a local manufacturing company that is seeking to add an engineer to their team. This is an opportunity for an experienced engineer with a background in a medical device environment in project, continuation, quality, or research and development engineering. If you are a highly organized engineer with an innate problem-solving and collaborative nature, please keep reading to see if this is the right opportunity for you. In this role, you will be a key contributor with an ability to make a real impact.
What you would be doing:Ensure products remain in conformance with regulatory requirements by developing test plans, protocols and reportsMaintain 1000’s of products to State-of-the-ArtAct as project lead for FDA, MDR and CE Class I, II and III productsProvide effective communication of project plans, budgets, resources, and timelinePerform gap analysis of relevant standards to determine actions needed to maintain technical documentation and declaration of conformance to state-of-the-art (Biocompatibility, Packaging, Sterilization, Reprocessing, Human Factors, etc.)Oversee production sterilization activities to ensure products may be released to the market.Author and maintain test plans, protocols and reports for Verification and Validation activities, applying appropriate statistical methodologiesRisk Management activitiesProvide support with troubleshooting of manufacturing processes or product issues with manufacturing partners.Documentation in compliance with ISO 13485 and FDA 820 quality systems, including design controlApply knowledge of ASME Y14.100:2017 Engineering Drawing Practices for creating and maintaining engineering drawings using appropriate tolerances considering design needs and manufacturing process capabilities.What you have:Bachelor's degree in Engineering or related science field5+ years of experience in medical device is requiredKnowledge of product conformance for the FDA, MDR, and CE Marking processTechnical Writing skillsAutoCAD and/or SolidWorks – or similar 2D and 3D drafting/modeling softwareKnowledge of ISO 13485 requirementsExperience with various aspects of medical device development, such as human factors, biocompatibility, sterilization, packaging, etc.Strong problem-solving skills with a collaborative natureAbility to lead cross-functional teams
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Konik is partnering with a local manufacturing company that is seeking to add an engineer to their team. This is an opportunity for an experienced engineer with a background in a medical device environment in project, continuation, quality, or research and development engineering. If you are a highly organized engineer with an innate problem-solving and collaborative nature, please keep reading to see if this is the right opportunity for you. In this role, you will be a key contributor with an ability to make a real impact.
What you would be doing:Ensure products remain in conformance with regulatory requirements by developing test plans, protocols and reportsMaintain 1000’s of products to State-of-the-ArtAct as project lead for FDA, MDR and CE Class I, II and III productsProvide effective communication of project plans, budgets, resources, and timelinePerform gap analysis of relevant standards to determine actions needed to maintain technical documentation and declaration of conformance to state-of-the-art (Biocompatibility, Packaging, Sterilization, Reprocessing, Human Factors, etc.)Oversee production sterilization activities to ensure products may be released to the market.Author and maintain test plans, protocols and reports for Verification and Validation activities, applying appropriate statistical methodologiesRisk Management activitiesProvide support with troubleshooting of manufacturing processes or product issues with manufacturing partners.Documentation in compliance with ISO 13485 and FDA 820 quality systems, including design controlApply knowledge of ASME Y14.100:2017 Engineering Drawing Practices for creating and maintaining engineering drawings using appropriate tolerances considering design needs and manufacturing process capabilities.What you have:Bachelor's degree in Engineering or related science field5+ years of experience in medical device is requiredKnowledge of product conformance for the FDA, MDR, and CE Marking processTechnical Writing skillsAutoCAD and/or SolidWorks – or similar 2D and 3D drafting/modeling softwareKnowledge of ISO 13485 requirementsExperience with various aspects of medical device development, such as human factors, biocompatibility, sterilization, packaging, etc.Strong problem-solving skills with a collaborative natureAbility to lead cross-functional teams
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