Sr Quality Engineer

Company: Lancesoft INC
Location: Lafayette
Posted on: February 18, 2026

Job Description:

Job Description Job Description Title: Sr Quality Engineer Location: Lafayette, CO 80026 (4 days onsite) Job Description: Must Have: Medical device design, development & manufacturing, experience of products with electrical functionality an advantage. Examples of critical thinking and proven project execution. Leading a cross functional teams and leveraging solid PM skills e.g. project planning, communication, risk management, etc. Work collaboratively and with respect & humility with a cross functional team to drive project execution for medical devices, prioritizing safety, quality service, on-time execution. Lead team to define goals, provide solutions and align on path forward, drive/track/communicate progress, adapt as needed with team. Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures. Use scientific problem solving methodologies e.g. DMAIC, process map, 5 whys, Is/Is not, etc. Drive solid decision making. Attention to detail, accuracy, to ensure own work meets required standard (compliant to quality management system, grounded in scientific facts and/or data, within safety/scope/schedule/cost guidance). Understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges Nice To Have: 2 years Product development experience, Intimate knowledge of Risk Management As a design quality engineer, you will work with a cross-functional team to develop new products or new features on existing products for Acute Care & Monitoring business. You will review user and system requirements, design documentation, test plans, test protocols, test reports, and deliverables per the development procedures. You will work cross functionally to review FMEAs and security evaluations and transfer those risks into risk management files for the product under development. Top 3 technical skills: · Understanding of systems engineering – requirements flow from user needs to system requirements to subsystem requirements. · Understanding of Risk Management standard: ISO 14971 and how to apply it to hardware and software (IEC TR 80002-1). · Familiarity with medical devices standards for electrical safety (IEC 60601), software (IEC 62304), and biocompatibility/sterilization (ISO 10993). Education Required: Bachelor’s degree in an engineering discipline Years’ Experience Required: Up to 8 years Product line will this person support: Acute Care & Monitoring

Keywords: Lancesoft INC, Lafayette , Sr Quality Engineer, Engineering , Lafayette, Louisiana