Medical Device Assembler

Hi, We Are NovaradNovarad’s Enterprise Healthcare solutions help senior executives, clinicians and IT professionals deliver clinical, operational, and fiscal excellence. With a self-sustaining business model, more than three decades of technology leadership, and an intense focus on our customers’ needs, Novarad brings people and technology together in ways no one else can. We’re driven by innovation that truly transforms healthcare - for the provider and their patient.Novarad is looking for a Medical Device Assembler to support the assembly, packaging, labeling, and sterilization management of regulated medical products. This role operates in a controlled cleanroom environment and follows strict quality system requirements to ensure products meet regulatory, safety, and performance standards.The ideal candidate is detail-oriented, quality-driven, and experienced in regulated production environments, with familiarity in sterilization processes, dose audits, and biocompatibility testing workflows.This is an onsite opportunity in our Provo office. Local candidates only, please.Novarad Offers:Competitive salary with generous PTOHealth, dental, vision, life, and disability insurancesHSA option with dollar-for-dollar match401k with dollar-for-dollar matchLow Cost Onsite Medical ClinicWellness programSundance corporate passesKey ResponsibilitiesCleanroom Assembly & PackagingAssemble medical devices and components according to approved work instructions, drawings, and SOPsPerform sterile and non-sterile packaging operations, including sealing and labelingVerify product configuration, labeling accuracy, and lot traceabilityMaintain cleanroom discipline, gowning procedures, and environmental controlsMaintenance of the cleanroom and production facilitiesQuality inspections of incoming partsInventory  controlSterilization & Quality SupportSupport sterilization workflows (e.g., EO, gamma, or other modalities), including preparation and documentationAssist with sterilization dose audits and verification activitiesSupport biocompatibility testing processes, including sample preparation, documentation, and traceabilityEnsure products meet release criteria prior to distribution Documentation & Compliance Accurately complete batch records, device history records (DHRs), and production logsFollow all applicable quality system procedures and regulatory requirementsIdentify and report nonconformances, deviations, or potential quality issuesSupport audits and inspections by maintaining organized and compliant recordsAccurately complete batch records, device history records (DHRs), and production logsFollow all applicable quality system procedures and regulatory requirementsIdentify and report nonconformances, deviations, or potential quality issuesSupport audits and inspections by maintaining organized and compliant recordsContinuous Improvement & TeamworkParticipate in training, process improvements, and corrective actionsCollaborate with Quality, Engineering, and Operations teamsMaintain a clean, organized, and compliant work environmentQualificationsRequired QualificationsHigh school diploma or equivalent (technical or associate degree preferred)Experience working in a regulated manufacturing environment (medical device, pharmaceutical, biotech, or similar)Familiarity with cleanroom operations and contamination control practicesExperience with product assembly, packaging, sealing, and labelingUnderstanding of quality documentation and traceability requirementsStrong attention to detail and ability to follow written procedures preciselyPreferred QualificationsManufacturing Experience in a highly regulated industryFamiliarity with sterilization processes (EO, gamma, or similar)Experience supporting dose audits or sterilization validation activitiesExposure to biocompatibility testing workflows or sample handlingKnowledge of FDA Quality System Regulation (QSR) and ISO 13485 conceptsPhysical & Work RequirementsAbility to work extended periods in a cleanroom environmentAbility to follow gowning and PPE requirementsManual dexterity for precise assembly tasksAbility to lift up to 40 lbs, as requiredNovarad is an equal opportunity employer. Our recruits come from all walks of life; our customers come from all walks of life; and so do we. Novarad celebrates an inclusive and diverse workforce. This makes our team stronger by sharing our differences and experiences in open and creative conversation. Come share your differences with us.Company DescriptionNovarad, a leader in healthcare IT and imaging solutions is home to a rich culture of innovation, evident in our constantly evolving product lines, currently AI and AR focused. Our products and solutions transform healthcare -- for providers and their patients. If you want to work for a company that really makes a difference, this is the place.

Salary : $17 - $21