Medical Device Assembler

Novarad Corporation•Provo, UT

7h•Onsite

About The Position

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

Requirements

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 practices
Experience with product assembly, packaging, sealing, and labeling
Understanding of quality documentation and traceability requirements
Strong attention to detail and ability to follow written procedures precisely
Ability to work extended periods in a cleanroom environment
Ability to follow gowning and PPE requirements
Manual dexterity for precise assembly tasks
Ability to lift up to 40 lbs, as required

Nice To Haves

Manufacturing Experience in a highly regulated industry
Familiarity with sterilization processes (EO, gamma, or similar)
Experience supporting dose audits or sterilization validation activities
Exposure to biocompatibility testing workflows or sample handling
Knowledge of FDA Quality System Regulation (QSR) and ISO 13485 concepts

Responsibilities

Assemble medical devices and components according to approved work instructions, drawings, and SOPs
Perform sterile and non-sterile packaging operations, including sealing and labeling
Verify product configuration, labeling accuracy, and lot traceability
Maintain cleanroom discipline, gowning procedures, and environmental controls
Maintenance of the cleanroom and production facilities
Quality inspections of incoming parts
Inventory control
Support sterilization workflows (e.g., EO, gamma, or other modalities), including preparation and documentation
Assist with sterilization dose audits and verification activities
Support biocompatibility testing processes, including sample preparation, documentation, and traceability
Ensure products meet release criteria prior to distribution
Accurately complete batch records, device history records (DHRs), and production logs
Follow all applicable quality system procedures and regulatory requirements
Identify and report nonconformances, deviations, or potential quality issues
Support audits and inspections by maintaining organized and compliant records
Participate in training, process improvements, and corrective actions
Collaborate with Quality, Engineering, and Operations teams
Maintain a clean, organized, and compliant work environment