{"schemaVersion":"jobsearcher.job.v1","id":"a9e5f51f9f45e23752311a21","url":"https://jobsearcher.com/jobs/a9e5f51f9f45e23752311a21","canonicalUrl":"https://jobsearcher.com/jobs/a9e5f51f9f45e23752311a21","title":"Lead Systems Engineer","description":"Lead Systems Engineer – Design Control RemediationLocation: Bothell, WAJob Type: Long-Term ContractOnly W2 Position OverviewWe are seeking an experienced Lead Systems Engineer to support design control remediation activities for a portfolio of released Class I and Class II medical devices. This role will focus on identifying and resolving gaps across requirements management, risk management, traceability, and design verification as part of a post-inspection remediation program.The successful candidate will provide strong engineering judgment, determine the appropriate level of remediation, and ensure all records are technically sound, traceable, and ready for customer and regulatory review.Key ResponsibilitiesLead remediation activities for assigned design control gaps and drive records through completion and approval.Evaluate existing records and determine whether they require minor corrections, targeted remediation, or complete reconstruction.Develop, revise, and maintain system and subsystem requirements throughout the product hierarchy.Establish and restore traceability between user needs, system requirements, design inputs, risk controls, and verification activities.Review and remediate DFMEA, Usability FMEA, and other risk management documentation at product, subsystem, element, and component levels.Ensure identified risks and risk controls are appropriately connected to corresponding requirements and verification evidence.Evaluate existing verification documentation and determine when additional testing, protocol updates, or evidence reconstruction is required.Develop verification strategies, protocols, acceptance criteria, and supporting documentation where gaps exist.Identify recurring remediation issues and establish standardized corrective approaches that can be applied consistently across multiple products.Create and maintain a gap/failure classification framework to improve remediation efficiency and consistency.Perform detailed quality reviews before deliverables are submitted to the customer engineering team.Establish clear work packages, technical instructions, and acceptance criteria for offshore engineering/support teams.Review offshore deliverables for technical accuracy, completeness, traceability, and compliance before customer submission.Serve as the senior technical escalation point during customer design reviews and remediation discussions.Prepare concise weekly status reports covering completed work, items under review, blockers, risks, and overall progress against the remediation plan.Required QualificationsBachelor's or Master's degree in Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related technical discipline.8+ years of experience in medical device systems engineering, systems design, design assurance, or related engineering functions.Minimum 3 years of experience supporting design control remediation, regulatory remediation, design assurance, or post-inspection activities.Hands-on experience managing and defining system requirements across the medical device product development lifecycle.Strong understanding of requirements decomposition and end-to-end traceability from user needs through verification and validation.Direct experience supporting FDA 483, Warning Letter, or similar regulatory remediation activities.Strong working knowledge of ISO 14971, ISO 13485, and 21 CFR 820.30.Experience authoring or remediating DFMEA, Usability FMEA, risk controls, system requirements, and verification documentation.Ability to independently develop and review verification protocols, test methods, acceptance criteria, and verification evidence.Experience working with PLM and ALM platforms; familiarity with Windchill and Codebeamer is highly desirable. Equivalent tools will also be considered.Strong technical communication skills with the ability to explain and defend engineering decisions to customer stakeholders.Demonstrated ability to lead technical discussions, challenge gaps, and drive remediation decisions to closure.Preferred QualificationsExperience working with released medical device products in a regulated environment.Experience with portfolio-level remediation and standardization of recurring design control issues.Experience coordinating engineering activities with offshore or distributed teams.Strong documentation, analytical, and problem-solving skills.Ability to work independently in a customer-facing engineering environment.Work Authorization & Onsite RequirementCandidates must have valid authorization to work in the United States.Must be available to work onsite in Bothell, Washington, approximately three days per week.This is a long-term contract opportunity.","company":"Systems Ally","rawCompany":"systems ally","city":"Bothell","state":"WA","isRemote":false,"isActive":false,"createdAt":"2026-08-13T12:10:33.846Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"},{"code":"11-9041.00","title":"Architectural and Engineering Managers","slug":"architectural-and-engineering-managers"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Lead Systems Engineer","description":"Lead Systems Engineer – Design Control RemediationLocation: Bothell, WAJob Type: Long-Term ContractOnly W2 Position OverviewWe are seeking an experienced Lead Systems Engineer to support design control remediation activities for a portfolio of released Class I and Class II medical devices. This role will focus on identifying and resolving gaps across requirements management, risk management, traceability, and design verification as part of a post-inspection remediation program.The successful candidate will provide strong engineering judgment, determine the appropriate level of remediation, and ensure all records are technically sound, traceable, and ready for customer and regulatory review.Key ResponsibilitiesLead remediation activities for assigned design control gaps and drive records through completion and approval.Evaluate existing records and determine whether they require minor corrections, targeted remediation, or complete reconstruction.Develop, revise, and maintain system and subsystem requirements throughout the product hierarchy.Establish and restore traceability between user needs, system requirements, design inputs, risk controls, and verification activities.Review and remediate DFMEA, Usability FMEA, and other risk management documentation at product, subsystem, element, and component levels.Ensure identified risks and risk controls are appropriately connected to corresponding requirements and verification evidence.Evaluate existing verification documentation and determine when additional testing, protocol updates, or evidence reconstruction is required.Develop verification strategies, protocols, acceptance criteria, and supporting documentation where gaps exist.Identify recurring remediation issues and establish standardized corrective approaches that can be applied consistently across multiple products.Create and maintain a gap/failure classification framework to improve remediation efficiency and consistency.Perform detailed quality reviews before deliverables are submitted to the customer engineering team.Establish clear work packages, technical instructions, and acceptance criteria for offshore engineering/support teams.Review offshore deliverables for technical accuracy, completeness, traceability, and compliance before customer submission.Serve as the senior technical escalation point during customer design reviews and remediation discussions.Prepare concise weekly status reports covering completed work, items under review, blockers, risks, and overall progress against the remediation plan.Required QualificationsBachelor's or Master's degree in Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related technical discipline.8+ years of experience in medical device systems engineering, systems design, design assurance, or related engineering functions.Minimum 3 years of experience supporting design control remediation, regulatory remediation, design assurance, or post-inspection activities.Hands-on experience managing and defining system requirements across the medical device product development lifecycle.Strong understanding of requirements decomposition and end-to-end traceability from user needs through verification and validation.Direct experience supporting FDA 483, Warning Letter, or similar regulatory remediation activities.Strong working knowledge of ISO 14971, ISO 13485, and 21 CFR 820.30.Experience authoring or remediating DFMEA, Usability FMEA, risk controls, system requirements, and verification documentation.Ability to independently develop and review verification protocols, test methods, acceptance criteria, and verification evidence.Experience working with PLM and ALM platforms; familiarity with Windchill and Codebeamer is highly desirable. Equivalent tools will also be considered.Strong technical communication skills with the ability to explain and defend engineering decisions to customer stakeholders.Demonstrated ability to lead technical discussions, challenge gaps, and drive remediation decisions to closure.Preferred QualificationsExperience working with released medical device products in a regulated environment.Experience with portfolio-level remediation and standardization of recurring design control issues.Experience coordinating engineering activities with offshore or distributed teams.Strong documentation, analytical, and problem-solving skills.Ability to work independently in a customer-facing engineering environment.Work Authorization & Onsite RequirementCandidates must have valid authorization to work in the United States.Must be available to work onsite in Bothell, Washington, approximately three days per week.This is a long-term contract opportunity.","datePosted":"2026-08-13T12:10:33.846Z","dateModified":"2026-08-13T12:10:33.846Z","hiringOrganization":{"@type":"Organization","name":"Systems Ally","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bothell","addressRegion":"WA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"a9e5f51f9f45e23752311a21"},"url":"https://jobsearcher.com/jobs/a9e5f51f9f45e23752311a21"}}