Medical Device Assembler

Description

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.

• 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

• 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

• 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

• 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

• 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

Novarad 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.