Hi, We Are Novarad
Novarad'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 PTO
- Health, dental, vision, life, and disability insurances
- HSA option with dollar-for-dollar match
- 401k with dollar-for-dollar match
- Low Cost Onsite Medical Clinic
- Wellness program
- Sundance corporate passes
Key Responsibilities
Cleanroom Assembly & Packaging
Assemble 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 Support
Support 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 distributionDocumentation & 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 & Teamwork
Participate in training, process improvements, and corrective actionsCollaborate with Quality, Engineering, and Operations teamsMaintain a clean, organized, and compliant work environmentRequirements
Qualifications
Required Qualifications
High 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 Qualifications
Manufacturing 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 Requirements
Ability 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.