The Staff Quality Engineer will support the development, and maintain key elements, of the Nuclein quality management system. Reporting to the Associate Director, Product Quality, this role will provide quality oversight of activities surrounding production, design and compliance. In collaboration with Operations, Engineering, and Assay Development colleagues and Nuclein’s suppliers, the Staff Quality Engineer ensures that our products meet the highest standards of quality and are compliant with all applicable regulations. This role handles escalated issues independently and proposes practical solutions to resolve challenges and make improvements. Serves as Subject Matter Expert in at least one quality discipline, such as Risk Management, Process Validation, Design Control, etc. This role is intended to be multi-disciplinary supporting production, design and regulatory efforts as needed.

Essential Duties and Responsibilities. 

·         Ensures manufacturing and testing of medical device IVDs is performed in accordance with Nuclein procedures and Good Manufacturing Practices (GMPs)

·         Completes documentation to the standard for external Regulatory Body review

·         Reviews and approves manufacturing and testing/inspection records, and authorizes product release

·         Leads the generation/approval of documents related to equipment qualification, facility qualification, process validation, test method validation, and risk management (PFMEA, hazard analysis, etc.)

·         Generates/reviews/approves equipment specifications, calibration/preventive maintenance reports, Nonconformances, Deviations and other quality records

·         Leads cross functional teams on complex projects achieving timelines and mentors others on the principles of quality

·         Quality representative for complex on-market design changes, new product development and regulatory submissions

·         Facilitates the Nuclein supplier quality management program and guides cross-functional partners through supplier selection, change control, and qualification processes

o    Conducts supplier audits (up to 10% travel)

o    Manages supplier change requests, notifications, deviations, and corrective action requests

·         Reviews/approves in complaints and related investigative activities

·         Leads the development and improvement of the QMS through the creation of processes and authoring of procedures

                   ·         Hosts internal and external inspections/audits

                   ·         Manages external resources responsibly

        ·         Performs other duties and responsibilities as assigned by management

Education, Qualifications, and/or Experience. 

·         B.S in Engineering or Science related field or equivalent experience required.

·         10+ years experience in a quality field required, experience in medical device ISO 13485 environment, or similar FDA regulated industry required

·         Experience working with IVDs preferred (PCR technology/platform a plus)

·         Expert experience in at least one quality discipline

·         Experience interfacing directly with external resources (suppliers, regulatory bodies, consultants)

·         Demonstrated ability to lead cross functional teams to achieve timelines

        ·         Have excellent written and verbal communication skills, with ability to train others in quality principles and operations

Physical Requirements.  

                  ·         Repetitive Motion: Mostly computer use

               ·         Weight Lifting: < 25 lbs  

                  ·         Position: Mostly sitting

               ·         Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

CANDIDATES MUST CURRENTLY LIVE IN THE AUSTIN, TX AREA - NO SPONSORSHIP IS OFFERED AT THIS TIME

The Buyer I will be responsible for the purchasing of floor stock items, services and miscellaneous purchase requests to support manufacturing. This role will also support inventory related activities, such as cycle counting and picking of inventory to support manufacturing. 

Essential Duties and Responsibilities. 

·         Reviews MRP messages and Issues PO’s for inventory to support the demand plan.

·         Places orders to maintain PAR levels of all floor stock items.

·         Issues PO’s as requested for non-inventory items or services and tracks approval status. 

·         Manages and orders supplies (Shipping supplies & manufacturing supplies)

·         Contact vendors to obtain information regarding shipping status of orders or special orders placed by department.

·         Request RMA’s from suppliers and processes returns to suppliers in the ERP system.

·         Track inbound shipments from the time they are in-transit until they are delivered to destination.

·         Follows up with suppliers to resolve receiving variances.

·         Supports warehouse activities in cycle counting of inventory and components as determined by the program and research variances.

·         Processes and picks work orders in the ERP system to support production schedules.

·         Assists the warehouse team with picking, packing, and processing of sales orders of finished goods in the ERP system; arranges for shipment of orders by delivery date on order.

·         Works with outside partners such as FedEx, UPS, and inventory suppliers.

·         Organizes and labels inventory areas with appropriate descriptions.

·         Performs inventory analysis and reporting in Excel to support inventory management and planning decisions.

·         Supports material planning activities as needed. 

·         Other duties as assigned to support the company 

Education, Qualifications, and/or Experience. 

·         Bachelor’s degree in Business Management or a Purchasing Certification preferred

·         Minimum of 1 year manufacturing procurement support in lieu of degree or certification can be considered

·         Outstanding prioritization, time management and organizational skills

·         Strong attention to detail and outstanding problem-solving skills.

·         Desire to learn & improve processes.

·         Ability to learn new software systems

·         Professional communication skills

·         Positive attitude in contributing to other areas outside job responsibilities.

·         Works effectively with other departments 

·         Skill in basic arithmetic.

·         Fluent in English

·         Microsoft Office (Outlook, Word and Excel) experience with proficiency in Excel

Physical Requirements.  

·         Repetitive Motion: Mostly computer use

·         Weight Lifting: < 40 lbs

·         Position: Mostly sitting with some standing and lifting in the warehouse

·         Speaking and communicating

·         Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas 

CANDIDATES MUST CURRENTLY LIVE IN THE AUSTIN,TX AREA - NO SPONSORSHIP IS BEING OFFERED AT THIS TIME

The Assistant Controller is responsible for supervising the day-to-day accounting operations, supporting financial reporting, and assisting with compliance activities of our company. Reporting to the Controller, this position requires a strong understanding of accounting principles, attention to detail, the ability to supervise accounting staff, and the ability to collaborate effectively with cross-functional teams.

Essential Duties and Responsibilities 

• Supervise the company's day-to-day accounting operations and staff, including general ledger, accounts payable, accounts receivable, and related functions to drive strong performance.
• Ensure accurate and timely recording of financial transactions in accordance with generally accepted accounting principles (GAAP), including ensuring daily cash balance transactions set up/approved.
• Assist with the preparation of GAAP financial statements, including income statements, balance sheets, and cash flow statements, providing accurate and clear reports to support the Controller and management team.
• Support the budgeting and forecasting processes, working closely with the CFO, Controller and other departments to ensure alignment with business objectives.
• Oversee the month-end, and year-end close processes, plus ongoing and annual tax preparation, including reconciliations, accruals, and staying ahead of expected due dates.
• Adherence to internal controls, policies, and procedures to safeguard company assets, ensure compliance with financial regulations, and mitigate financial risks.
• Support the external audit process, preparing schedules and providing necessary documentation to auditors in a timely manner.
• Stay updated on accounting standards and regulations, ensuring compliance and recommending changes to accounting policies and practices as necessary.
• Support the Controller in ad hoc financial analysis, special projects, and process improvement initiatives.

Education, Qualifications, and/or Experience

• Bachelor’s degree in Accounting, Finance, or a related field required.
• 10 years of progressive experience in accounting roles, especially internal accounting processes, required. 
• Solid understanding of US GAAP and financial reporting requirements required. CPA or CPA candidate is a plus.
• Experience in the medical device or healthcare industry preferred.
• Experience supervising accounting operations, including accounts payable, accounts receivable, and general ledger required.
• Strong analytical and problem-solving skills, with the ability to interpret and analyze financial data and provide actionable insights.
• Advanced proficiency in accounting software, spreadsheets, and ERP systems required. Experience with Microsoft Business Central or similar systems is a plus.
• Excellent attention to detail and accuracy, with the ability to meet deadlines in a fast-paced environment.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• High ethical standards and integrity, with the ability to handle confidential and sensitive information appropriately.
• Strong organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
• Experience in a publicly traded company or familiarity with SEC reporting requirements is a plus.

Physical Requirements 

• Repetitive Motion: Mostly computer use
• Weight Lifting: <25 lbs 
• Position: Mostly sitting
• Speaking and communicating
• Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

Local candidates only. Sponsorship is not available at this time. 

The Sr Service Depot Technician will troubleshoot and service Instruments and/or sub-assemblies and modules, working within established SOPs to develop and follow best processes for testing and troubleshooting.

Essential Duties and Responsibilities. 

·         Perform decontamination of instruments returning from the field

·         Troubleshoot and repair instruments in the Service Depot

·         Collaborate with engineering to address instrument failures

·         Test and troubleshoot finished products for quality defects

·         Document/Record activities and data on Batch Records/Device History Records (DHRs) and or Servicing Records

·         Ensure completeness and accuracy of completed records

·         Interpret engineering drawings and technical documentation

·         Discern quality of parts and materials used in production

·         Inventory parts and tools used in the Depot process

·         Accumulate and prepare performance data

·         Follow company Standard Operating Procedures (SOPs) and directives

·         Help improve processes and provide feedback to ensure better output

·         Maintain the tools used to diagnose and repair products                                                                                                                                                                                 

                ·         Keep a clean and well-maintained workspace and equipment

Education, Qualifications, and/or Experience. 

·         Associates degree in electronics, or equivalent Military or work-related training in electrical test and repair preferred.

·         Minimum 5 years testing or technician experience preferred

·         Prior cleanroom and medical device experience preferred

·         Experience using ESD procedures

·         Prior experience working in an FDA regulated or ISO manufacturing environment with GMP knowledge preferred

·         Ability to follow strict protocols and adhere to quality standards

·         Ability to read and understand manufacturing instructions and SOPs, blueprints and schematics

·         Strong troubleshooting and problem-solving skills

·         Strong communication skills

·         Strong computer skills, including MS Office, internet and email

·         Possess excellent hand-eye coordination with an attention to detail

·        Flexibility to handle changing needs and demands, as well as navigate process improvements

·       Experience working with small and intricate parts

                ·       Must possess strong teamwork skills and work well with others

Physical Requirements.  

·         Repetitive Motion: Mostly computer use

·         Weight Lifting: < 25 lbs

·         Ability to sit or stand for extended periods of time

·         Must possess good communications skills

                ·         Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

        LOCAL CANDIDATES ONLY - SPONSORSHIP IS NOT OFFERED AT THIS TIME

The Manufacturing Supervisor will provide front-line support for Nuclein’s manufacturing operations. The individual will be responsible for overseeing day-to-day manufacturing activities, ensuring compliance with FDA regulations and GMP guidelines, and contributing to continuous improvement initiatives to optimize efficiency and product quality.

Essential Duties and Responsibilities:      

• Front-line support for Nuclein’s manufacturing operations, ensuring adequate resources, manufacturing capacity and planning as well as assisting in coordinating the direct labor and test technician operations
• Follow and support required cGMP production processes and procedures.
• Monitor production metrics and support corrective actions as needed.
• Ensure strict adherence to FDA regulations and GMP guidelines through audits and daily oversight.
• Help coordinate and develop training documentation and plans for assembly team members.
• Collaborate with the Quality Assurance and Quality Control teams to address quality issues.
• Help identify opportunities for process optimization and efficiency improvements.
• Implement lean manufacturing principles to streamline operations.
• Participate in and support continuous improvement projects.
• Supervise and support a team of assembly personnel, and participate in the interviewing/hiring process as needed
• Foster a culture of teamwork, accountability, and continuous improvement.
• Participate in performance evaluations and provide coaching to team members.
• Promote a safe working environment by enforcing safety protocols.
• Investigate and report safety incidents, implementing preventive measures.
• Monitor department costs and escalate concerns as appropriate

Education, Qualifications, and/or Experience: 

• Associate’s degree required with bachelor’s degree preferred
• At least 5 years of experience in manufacturing operations or equivalent role(s) required, preferably in the medical device industry
• Experience operating in environments of FDA regulations and GMP guidelines required
• Excellent problem-solving and decision-making skills.
• Ability to support process improvements and contribute to cost reduction efforts.
• Ability to work collaboratively, explain the ‘Why,’ and be able to influence others in a fast-paced environment.
• Ability to operate with general supervision and escalate issues appropriately.
• Ability to work cross-functionally to ensure all manufacturing objectives are met.
• Possesses a high level of attention to detail and organization.
• Ability to prioritize tasks and to delegate them when appropriate.
• Experience in using/navigating ERP systems
• Proficient with Microsoft Office Suite or related software to complete reports and logs.

Physical Requirements:  

• Repetitive Motion: Mostly computer use
• Weight Lifting: at least 25 lbs
• Position: Mostly sitting
• Speaking and communicating
• Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

LOCAL CANDIDATES ONLY- SPONSORSHIP IS NOT OFFERED AT THIS TIME

The Quality Control (QC) Scientist II will support the development of, and maintain, key elements of the Nuclein quality management system. This role will provide support for QC activities related to incoming, component and finished product release and development of the Nuclein QC laboratory. In collaboration with Assay Development, Operations, and Engineering colleagues, the QC Scientist II will ensure that Nuclein products meet the highest standards of quality and are compliant with all applicable regulations.

Essential Duties and Responsibilities. 

·         Executes QC testing and inspection of materials for release to production and finished product testing, including record review for compliance

·         Authors, reviews, and executes QC test methods and procedures as a subject matter expert

·         Develops and reviews test method validation/verification protocols and reports

·         Supports the development and maintenance of QC laboratory, including authoring of Standard Operating Procedures (SOPs) for QC lab personnel

·         Supports day-to-day QC lab operations, including ordering/receiving supplies and operating/maintaining laboratory equipment

·         Supports investigations into deviations, non-conformances, and CAPAs, including authoring and approval of investigation records

·         Mentors QC Technicians

·         Ensures compliance to 21 CFR Part 820, ISO 13485, and other applicable regulations by providing support through interpretation of regulations and leading improvement initiative

·         Supports internal and external inspections/audits

        ·         Performs other duties and responsibilities as assigned by management, including leading cross-functional tasks                

Education, Qualifications, and/or Experience. 

·         Bachelor’s degree in a Science, such as Molecular Biology, Chemistry, Biomedical Sciences or related technical field

·         At least 5 years of experience in a laboratory setting, preferably within a medical device ISO 13485 environment, or similar FDA regulated industry

·         Experience working with IVDs preferred (PCR technology/platform a plus)

·         Hands-on experience in DNA, RNA, PCR and general molecular biology laboratory techniques preferred

·         Ability to properly operate laboratory tools and equipment including pipettes, centrifuges, vortex mixers, incubators, PCR enclosures, biosafety cabinet, refrigerators and freezers

·         Familiar with statistical techniques for determine QC criteria and sample size

·         Ability to perform repetitive testing with a high level of attention to detail

·         Have excellent written and verbal communication skills – able to train others in quality principles and operations

Physical Requirements.  

·         Repetitive Motion: Mostly computer use

·         Weight Lifting: < 25 lbs

·         Position: Standing and sitting

·         Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

        Local candidates only. Sponsorship is not being offered at this time. No recruiters or agencies, please. 

The Manufacturing Engineer provides technical support to Nuclein cGMP manufacturing operations. This role will focus on instrument and cartridge production and production support. Position interfaces directly with Quality Assurance, Production Personnel, Supply Chain, Engineering and Assay Development to ensure the on-time delivery of high-quality devices in line with company growth and supply demands.

Essential Duties and Responsibilities:

• Lead and manage manufacturing engineering activities such as validations, test equipment design, test procedure development, process development and automation equipment implementation.
• Work with Development groups for the implementation of engineering changes to the manufacturing process
• Monitor production metrics and implement proactive corrective actions and process efficiency improvements as needed.
• Develop equipment, fixtures and tools that are needed for the manufacturing process.
• Ensure strict adherence to FDA regulations and GMP guidelines through process development and oversight.
• Resolve CAPAs and product Non-Conformances for the factory floor including supporting MRB functions
• Support 3rd party compliance audits.
• Provide technical support for Design for Manufacturability and product changes
• Foster a culture of teamwork, accountability, and continuous improvement.
• Develop Manufacturing Instructions as required.  Including training to Direct Labor as needed
• Develop and train processes to improve compliance and accountability such as Line Clearance and Label Line Clearance
• Implement lean manufacturing principles to streamline operations.
• Support development and direct support of instrument assembly manufacturing lines identifying needed equipment and test fixtures.  Including process development, maintenance, training, and monitoring
• Work directly with suppliers to resolve Materials issues.
• Develop BOMs, routings and other manufacturing process documentation as required
•  Support returned product rework and repair including work instruction and test procedure development

Education, Qualifications, and/or Experience:

• Bachelor’s degree in a relevant field
• 3+ years of experience in manufacturing engineering support responsibilities in the medical device industry.  Specifically in instrument manufacturing is desired
• Experience operating in environments of FDA regulations and cGMP guidelines such as CFR820 and ISO13485-2016 is desired.
• Excellent problem-solving and decision-making skills.
• Demonstrated ability to drive process improvements and cost reductions.
• Ability to work collaboratively, explain the ‘Why,’ and be able to influence others in a fast-paced environment
• Ability to operate independently with moderate supervision
• Possess a high level of attention to detail and organization
• Ability to prioritize tasks and to delegate them when appropriate
• Proficient with Microsoft Office Suite or related software to complete reports and logs
• Must be able to traverse the facility
• Must be able to lift 25 pounds at a time

Physical Requirements.

• Repetitive Motion: Mostly computer use
• Weight Lifting: > 25 lbs
• Position: Mostly sitting
• Speaking and communicating
• Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

THIS POSITION IS 100% ONSITE IN AUSTIN, TX. CANDIDATES MUST CURRENTLY LIVE WITHIN COMMUTING DISTANCE TO BE CONSIDERED. NO SPONSORSHIP IS BEING OFFERED AT THIS TIME.

Reporting to the Head of Customer Support, the Customer Success Manager (CSM) is responsible for ensuring customers successfully adopt, utilize, and realize maximum value from the Nuclein DASH® Rapid PCR System. The CSM serves as a trusted advisor and primary post-implementation customer contact, focused on driving customer satisfaction, utilization growth, retention, and long-term success across the installed base. Working closely with Customer Support, Training, Sales, Marketing, and Operations, the CSM proactively engages customers to optimize system performance, increase testing utilization, promote software and connectivity adoption, and identify opportunities to enhance the overall customer experience. Through ongoing customer engagement, performance monitoring, and issue resolution, the CSM helps maximize customer outcomes while supporting the growth and retention of recurring revenue.

Essential Duties and Responsibilities: 

Revenue Generation, Utilization & Reorder Management

·         Assist Commercial team in developing account segmentation and health scoring models that classify customers by utilization tier, risk level, and growth potential, ensuring consistent prioritization across the installed base.

·         Monitor account-level utilization, testing trends, and reorder activity to identify opportunities for increased adoption, revenue growth, and risk mitigation.

·         Drive performance against key business metrics, including system utilization, testing volume, reorder frequency, customer activation, and recurring revenue growth.

·         Analyze utilization, reorder, reimbursement, and workflow data to identify root causes of underperformance and develop account-specific strategies to increase test volumes and customer value.

·         Segment and prioritize accounts based on business impact, utilization trends, and growth potential, developing targeted success plans in collaboration with Regional Sales Managers/Directors (RSMs/RSDs) and distribution partners.

·         Partner with sales and distributor teams to support timely cartridge and consumable replenishment, reduce inventory disruptions, and maximize testing continuity.

·         Identify opportunities to expand testing utilization through workflow optimization, menu adoption, reimbursement education, and customer best-practice sharing.

·         Support company initiatives designed to increase recurring revenue, customer retention, and long-term account growth.

Customer Onboarding & Adoption

·         Partner with Customer Support, Sales, Training, and distributor teams to deliver a seamless onboarding experience and accelerate time-to-value.

·         Drive performance against onboarding KPIs, including activation rates, onboarding completion, time-to-first-test, and early-stage utilization benchmarks.

·         Conduct proactive customer outreach during the onboarding period to reinforce training, address barriers to adoption, and promote testing utilization.

·         Exercise independent judgment when identifying and resolving customer adoption challenges related to workflow integration, reimbursement, connectivity, or operational processes.

·         Serve as a customer-facing resource for DASH® reimbursement and exercise sound judgment in determining when issues require escalation to internal subject matter experts or external resources.

Customer Experience, Retention & Account Health

·         Assist Commercial team in developing a standardized customer playbook (including defined intervention pathways, responsibility models, escalation processes, etc.) for identifying and managing at-risk accounts

·         Develop trusted relationships with customers and serve as a primary post-sale customer advocate for Nuclein.

·         Assess overall account health by monitoring utilization trends, engagement levels, customer feedback, support history, competitive activity, and operational performance.

·         Identify customers at risk of low utilization, disengagement, or attrition and develop/execute proactive retention and recovery strategies.

·         Lead structured customer engagement activities, including follow-ups and utilization assessments.

·         Capture the voice of the customer, ensuring customer feedback, needs, and market insights are effectively communicated.

·         Own and drive key customer success metrics, including retention, utilization growth, and customer satisfaction.

Data Analytics, Insights & Continuous Improvement

·         Maintain accurate and timely account, contact, utilization, engagement, and activity records within HubSpot CRM and related business systems.

·         Perform detailed data analysis to identify utilization trends, customer adoption patterns, revenue opportunities, and churn risks translating findings into actionable recommendations.

·         Develop and maintain dashboards, scorecards, and performance metrics to monitor customer success outcomes and support business planning.

·         Generate, analyze, and interpret reports related to utilization, reorder activity, customer engagement, retention, and onboarding.

·         Provide actionable insights and structured feedback to Sales, Marketing, Customer Support, Operations, and Leadership regarding customer needs, recurring challenges, competitive activity, and market opportunities.

·         Support the continuous improvement of customer success processes, programs, tools, and performance metrics.

Cross-Functional Collaboration

·         Partner closely with Customer Support, Sales, Marketing, Operations, and distributor partners to deliver consistent and exceptional customer experience.

·         Support new product launches, menu expansion initiatives, software updates, and customer communication programs designed to drive adoption and utilization.

·         Participate in strategic projects and initiatives that support Nuclein's commercial growth objectives and customer success strategy.

Administrative, Documentation & Compliance Responsibilities

·         Ensure customer interactions, account activities, and business records are documented accurately and maintained in accordance with company policies.

·         Maintain compliance with all applicable company policies, quality system requirements, regulatory standards, and customer communication guidelines.

·         Support internal audits, reporting requirements, and documentation requests as needed.

·         Perform other duties and special projects as assigned.

Education, Qualifications, and/or Experience:

Education

·         Associate’s or Bachelor’s degree in Business, Marketing, Communications, or a related field preferred.

·         Equivalent combinations of education, training, and relevant work experience will be considered.

Qualifications and Experience

·         Minimum of 5 years of experience in Customer Success, Customer Experience, Account Management, Customer Support, or related customer-facing role(s).

·         Experience in diagnostics, medical devices, biotechnology, healthcare, laboratory services, or other regulated healthcare environments preferred.

·         Knowledge of point-of-care testing, laboratory operations, clinical workflows, or healthcare reimbursement processes preferred.

·         Experience with customer success platforms, business intelligence tools, and data visualization software (e.g., HubSpot, Salesforce, Power BI, Tableau, Looker, or similar) preferred.

·         Demonstrated experience building customer success, utilization management, customer health scoring, and/or retention programs

Skills:

·         Strong customer relationship management and communication skills.

·         Excellent verbal, written, and interpersonal skills with the ability to engage effectively across customer and internal audiences.

·         Analytical mindset with the ability to interpret data and translate insights into action.

·         Strong organizational, time-management, and prioritization skills with the ability to manage multiple accounts and initiatives simultaneously.

·         Analytical and problem-solving skills with the ability to interpret data, identify opportunities, and drive customer adoption and utilization.

·         Proficiency with CRM systems, Microsoft Office applications, and reporting tools.

·         Self-motivated, collaborative, and results-oriented with strong problem-solving capabilities