Careers

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Accounting & Finance

Senior Analyst FP&A

Job Summary

The Sr. Analyst of FP&A works independently as a key business partner that will provide strategic and annual financial planning, modeling, forecasting, and analysis of operating expenses to various departments across the organization. This role will be responsible for expense planning and analysis and will work closely with key leaders across Inari.

This position will be responsible for key elements of the budgeting and forecasting processes, internal management reporting, monthly financial performance analysis as well as financial modeling. This position is instrumental in supporting new reporting capabilities and requirements, as well as system implementations.

Essential Responsibilities

  • Develop departmental expense reporting and assist in the preparation of worldwide management reporting packages including standard reports, metrics and variance commentary.
  • Support month-end close process and maintain close partnership with GL accounting and AP teams.
  • Assist with the preparation of presentations for senior management
  • Analyze current and past trends in key performance indicators; and provide accurate and timely financial reporting to management.
  • Assist team with financial modeling including development of the long-range strategic plan, AOP, and quarterly forecast for dedicated departments.
  • Work cross functionally to drive process improvements and automation.
  • Support the development and improvement of new and existing management reports and input templates.
  • Assists in the implementation and maintenance of critical business systems (Adaptive Insights) to meet company’s reporting requirements.
  • Assist with ensuring compliance with corporate financial policies and Sarbanes-Oxley requirements.
  • Support ad-hoc projects as required.

Skills Needed for Success

  • This position requires a highly motivated individual with strong analytical and problem-solving skills, attention to detail, business savvy, intellectual curiosity, and proven leadership skills.
  • Excellent organization and time management skills.
  • Interpersonal skills with the proven ability to build and maintain relationships and communicate professionally to all levels of an organization.
  • Strong understanding of Financial Statements
  • Strong commitment to continuous learning and improvement.
  • Strong software skills. Adaptive Insights and/or NetSuite experience highly desired.
  • Advanced Microsoft Excel and intermediate to advanced PowerPoint skills required.
  • Manufacturing and/or medical device company experience highly preferred.

Qualifications

  • Bachelor’s degree in Accounting or Finance required; CPA preferred.
  • A minimum of 5-7 years of finance, accounting or related business experience required, preferably in Medical Devices, Life Sciences, or Healthcare companies.
  • Knowledge of US GAAP, SOX compliance preferred along with Public Company experience.

Clinical

Senior Clinical Site Manager

Essential Responsibilities:

  • Perform all aspects of site nomination, selection, confirmation, execution, data collection, monitoring, and closure activities.
  • Develop strong customer relationships ensuring appropriate sponsor oversight of site.
  • Drive site recruitment strategies, data quality, and patient compliance to protocol.
  • Partner with study team to develop all study documents necessary for trial execution.
  • Contribute to drafting of protocols, patient informed consent forms and case report forms.
  • Deliver site training, updates, and study communication materials to sites.
  • Manage site payments, study contracts, consent approvals, IRB approvals, and other research processes with sites.
  • Maintain compliance to all SOP, GCP, and regulatory processes.
  • Ensure highest level of data quality at the site including driving resolution of queries.
  • Strong technical knowledge of Inari products and procedures.
  • Strong clinical process acumen and ability to drive clinical functional excellence activities.
  • Drive high quality data collection to support scientific communications, clinical research, and statistics evidence dissemination strategies.

Qualifications:

  • Bachelor’s degree in life sciences.
  • 8+ years of experience in executing and/or monitoring medical device clinical trials.
  • Medical device trials experience preferred.
  • Proficient with electronic databases used for clinical trials.
  • Experience with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
  • Preferred experience with remote monitoring or risk-based monitoring.

Clinical Site Manager

Essential Responsibilities:

  • Perform all aspects of site nomination, selection, confirmation, execution, data collection, monitoring, and closure activities.
  • Develop strong customer relationships ensuring appropriate sponsor oversight of site.
  • Drive site recruitment strategies, data quality, and patient compliance to protocol.
  • Partner with study team to develop all study documents necessary for trial execution.
  • Contribute to drafting of protocols, patient informed consent forms and case report forms.
  • Deliver site training, updates, and study communication materials to sites.
  • Manage site payments, study contracts, consent approvals, IRB approvals, and other research processes with sites.
  • Maintain compliance to all SOP, GCP, and regulatory processes.
  • Ensure highest level of data quality at the site including driving resolution of queries
  • Good technical knowledge of Inari products and procedures
  • Good clinical process acumen and ability to drive clinical functional excellence activities
  • Drive high quality data collection to support scientific communications, clinical research, and statistics evidence dissemination strategies.

Qualifications:

  • Bachelor’s degree in life sciences.
  • 4+ years of experience in executing and/or monitoring medical device clinical trials.
  • Medical device trials experience preferred.
  • Proficient with electronic databases used for clinical trials.
  • Experience with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
  • Preferred experience with remote monitoring or risk-based monitoring.

Clinical Research Data Manager

Essential Responsibilities:

  • Perform all aspects of clinical research data management including selection of appropriate clinical data, processes to collect and clean data, and reporting of data metrics to internal and external stakeholders.
  • Manage clinical trials through review, computerization, cleaning and auditing of clinical data and databases in compliance with standard operating procedures, client guidelines and regulatory agency guidelines.
  • Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines.
  • Generate data retrievals and summaries.
  • Query data inconsistencies and revise case report forms in compliance with standard operating procedures.
  • Implement strategy for data cleaning and the design and programming of clinical databases.
  • Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation.
  • Partner with Scientific communications on publication and evidence dissemination strategy through use of reliable clinical data.
  • Help validate clinical databases including designing or testing Queries and logic checks.
  • Track the flow of data including in-house data flow or electronic forms transfer.
  • Evaluate processes and technologies and suggest revisions to increase productivity and efficiency.
  • Perform quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data.
  • Generate data queries based on validation checks or errors and omissions identified during data entry to resolve identified problems.
  • Develop project-specific data management plans that address areas such as data coding, reporting, or transfer, database locks, and workflow processes.

Qualifications:

  • Bachelor’s degree in life sciences required.
  • Experience in medical device trials preferred.
  • Minimum of 8-10 years’ relevant clinical research experience with significant data management experience.
  • Proficient with electronic databases used for clinical trials.
  • Experience with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).

Manager, Statistical Programming 

Job Summary:

This position will be primarily responsible for statistical programming, analysis of clinical research studies, and providing programming support of publication efforts and regulatory submissions.

Qualificaitons:

  • MS in Statistics, Mathematics, or related fields.
  • 4+ years relevant work experience with statistical analysis and interpretation of data.
  • 3+ years relevant industry experience in Pharma, Med Device, CRO.
  • 3+ years clinical trial experience.
  • 3+ years clinical database experience and CDISC pipeline process.
  • Comprehensive knowledge of statistical methods.
  • Comprehensive knowledge of mathematical modeling.
  • Knowledge of software development packages (SAS, R, or other software packages).
  • Strong project management and problem-solving skills, and ability to effectively lead and collaborate with all functions.
  • High attention to detail including proven ability to manage multiple, competing priorities.
  • Proficiency in MS Office Suite including Word, PowerPoint, Access, and Excel.
  • Ability to manage multiple projects simultaneously.

Statistical Programmer I

Job Summary:

This position will be primarily responsible for statistical programming, analysis of clinical research studies, and providing programming support of publication efforts and regulatory submissions.

Qualifications:

  • MS in Statistics, Mathematics, or related fields.
  • 0-1+ years relevant work experience in statistical analysis and interpretation of data.
  • 0-1+ years relevant industry experience in Pharma, Med Device, CRO.
  • 0-1+ years clinical trial experience.
  • 0-1+ years clinical database experience and CDISC pipeline process.
  • Working knowledge of statistical methods.
  • Working knowledge of mathematical modeling.
  • Knowledge of software development packages (SAS, R, or other software packages)
  • Strong project management and problem-solving skills, and ability to effectively lead and collaborate with all functions.
  • High attention to detail including proven ability to manage multiple, competing priorities.
  • Proficiency in MS Office Suite including Word, PowerPoint, Access, and Excel.
  • Ability to manage multiple projects simultaneously.

Statistical Programmer II

Job Summary:

This position will be primarily responsible for statistical programming, analysis of clinical research studies, and providing programming support of publication efforts and regulatory submissions.

Qualifications:

  • MS in Statistics, Mathematics, or related fields.
  • 2+ years relevant work experience in statistical analysis and interpretation of data.
  • 2+ years relevant industry experience in Pharma, Med Device, CRO.
  • 2+ years clinical trial experience.
  • 2+ years clinical database experience and CDISC pipeline process.
  • Working knowledge of statistical methods.
  • Working knowledge of mathematical modeling.
  • Knowledge of software development packages (SAS, R, or other software packages).
  • Strong project management and problem-solving skills, and ability to effectively lead and collaborate with all functions.
  • High attention to detail including proven ability to manage multiple, competing priorities.
  • Proficiency in MS Office Suite including Word, PowerPoint, Access, and Excel.
  • Ability to manage multiple projects simultaneously.

Principal Biostatistician 

Job Summary:

This position will be primarily responsible for statistical design, analysis of clinical research studies, and providing statistical expertise in support of publication efforts and regulatory submissions.

Qualifiucations:

  • Ph.D. in Statistics, Biostatistics, or related fields.
  • Minimum 4-6 years of experience in clinical trials.
  • Computer science/programming education and experience strongly desired.
  • Proficiency in SAS and/or R statistical software.
  • Proficiency in data programming to facilitate statistical analyses.
  • Proficiency in MS Office Suite including Word, PowerPoint, Access, and Excel
  • Ability to manage multiple projects simultaneously.
  • Managerial track preferred.

Senior Biostatistician II

Job Summary:

This position will be primarily responsible for statistical design, analysis of clinical research studies, and providing statistical expertise in support of publication efforts and regulatory submissions.

Qualifications:

  • PhD in Biostatistics, Statistics, Epidemiology, Outcomes Research, Economics.
  • 2+ years relevant work experience in statistical analysis and interpretation of data.
  • Proficient programming in various languages (R, SAS, SPSS, etc.)
  • Extensive knowledge of statistical methods
  • Extensive knowledge of mathematical modeling
  • Strong project management and problem-solving skills, and ability to effectively lead and collaborate with all functions.
  • High attention to detail including proven ability to manage multiple, competing priorities.
  • Proficiency in MS Office Suite including Word, PowerPoint, Access, and Excel.
  • Ability to manage multiple projects simultaneously.

Commercial

Manager, Business Insights

Essential Responsibilities:

  • Challenge and drive major change initiatives using data-driven decision making across marketing, sales operations, and customer service.
  • Ability to forecast, using predictive analytics, and conduct necessary market research across the business and industry.
  • Create and maintain advanced data models and analysis. partnering with finance and commercial colleagues.
  • Deliver actionable recommendations to guide strategy and drive forecasting.
  • Collaborate across the business to improve and automate timely insights.
  • Support business development initiatives through dynamic market models.
  • Communicate results and business impacts of insight initiatives to key stakeholders.

Qualifications:

  • MBA or advanced degree in mathematical/analytical sciences preferred.
  • BS/BA in business, marketing, data science, engineering, mathematics, or another quantitative field preferred.
  • 8+ years’ business experience; people-leading experience preferred.
  • 5+ years’ experience with data science and analytics; proven record of delivering data-driven insights to inform strategic decision-making and influencing commercial strategy.
  • Commercial experience in the medical device or pharmaceutical industries preferred (sales, marketing, sales operations, etc.)
  • Advanced/expert level Excel skills with ability to create and automate dynamic models.
  • Technical expertise on systems, BI infrastructure, tech & reporting stack.
  • SQL experience strongly preferred, as well as BI tools like Tableau, Qlik, PowerBI, etc.
  • Experience with R, Python, SAS or similar data languages, statistical and advanced analytics tools.
  • Experience with data mining and pre-processing principles, collecting data from multiple data systems, classification, mapping, and structuring/staging.
  • Experience and knowledge of statistical modeling techniques: GLM multiple regression, logistic regression, log-linear regression, variable selection, etc.

Customer Service

There are currently no open positions in this department.

Engineering

R&D Project Engineer

Job Summary

Support and lead teams in the development of medical device products, including writing or verifying specifications, maintaining product process, designing fixtures, test processes, equipment and raw materials to ensure the concepts and/or prototypes meet their requirements.

Responsibilities

  • Develop new product concepts and products
  • Engineering design and process development
  • Generate intellectual property, write invention disclosures
  • Specifies and/or directs the specification and testing of new materials and designs.
  • Confers with appropriate departments, resources, and/or outside services to prepare design modifications, clarify problems and develop designs
  • Largely self-directed, capable of meeting project goals with minimal supervision

Qualifications

  • BS degree in related field
  • 2-5 years related medical device experience
  • Good communication skills
  • Design and development of medical devices
  • Reading and preparing technical documentation
  • Working knowledge of standard machine shop equipment and processes and medical device manufacturing equipment and processes
  • Knowledge of medical and technical development
  • Computer skills including Word, Excel and AutoCAD (Solidworks proficiency required)

Human Resources

There are currently no open positions in this department.

IT

IT Systems & Data Analyst

Job Summary

The IT Systems & Data Analyst is responsible for designing, implementing and managing new technology solutions to improve business efficiency and productivity. The work will primarily be for an internal client within the company. The IT Systems & Data Analyst works closely with the client to examine existing business models and flows of data, discuss their findings with the client, and design an appropriate improved IT solution. They act as the liaison between the internal and external teams. Demonstrates expertise in a variety of the field’s concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks and can function as a implementation project manager when needed. A wide degree of creativity and latitude is expected. This is an individual contributor position that offers specialized expertise to internal and external project teams, without the need to be managing a team of people.

 Qualifications

  • 4+ years in related role in addition to bachelor’s degree in Information Systems, Engineering, Data Science, Management Information Systems, or related field.
  • Strong experience in using cloud-based applications and services.
  • Proficient in using productivity (Office 365 preferred), project management tools, such as Asana, MS Project or equivalent.
  • Broad business and/or technical work experience.
  • Broad understanding of master data governance and analysis
  • Ability to translate technical requirements into executive friendly terms.
  • Demonstrate ability to work in a dynamic, collaborative environment
  • Strong written and oral communication skills, including an ability to articulate ideas clearly and appropriately influence others
  • Excellent organizational, interpersonal and teamwork skills

Production

Assembler

Essential Responibilities:

  • Using a variety of tools, fixtures, work instructions and test equipment perform a series of operations to correctly assemble/test medical devices.
  • Understand and follow detailed assembly instructions, processes and procedures.
  • Comply with policies, guidelines and regulatory requirements per the Quality System.
  • Provide hands on job function training to coworkers as needed.
  • Maintain a clean and organized work area to facilitate manufacturing functions.

Qualifications:

  • High school diploma or equivalent.
  • 1 to 5 years related medical device manufacturing experience.
  • Able to work in a cleanroom environment.
  • Knowledge of basic measuring techniques including scales, rulers, US and metric measurements.

Quality & Regulatory

Software Quality Engineer

Job Summary

The Software Quality Engineer will play a key role in the various business system software implementation and maintenance by driving quality improvements and validating quality criteria. This role will also have a broad range of responsibilities in project management and compliance.

Qualifications

  • 3+ years in related role in addition to bachelor’s degree in Information Systems, Quality Assurance, Software QA, or related field.
  • Experience interpreting large data sets and/or creating data analysis tools.
  • Experience in evaluating, using and/or supporting quality solutions, such as QMS, PLM, requirements management, training or related systems.
  • Experience with software validation planning and documentation.
  • Experience with medical device manufacturing field.
  • Broad business and/or technical work experience.
  • Ability to translate technical jargon into executive friendly terms.
  • Demonstrate ability to work in a dynamic, collaborative environment
  • Strong written and oral communication skills, including an ability to articulate ideas clearly and appropriately influence others
  • Excellent organizational, interpersonal and teamwork skills
  • Well versed in project management skills.

Regulatory Affairs Specialist – International ROW

Job Summary

Focus of this position is to prepare and maintain international regulatory submissions for device approvals in Canada, Australia, China, Japan, and other OUS territories.

Qualifications

  • Bachelor’s degree in a Life Science or related field preferred. Or, equivalent combination of education and experience to perform at this level.
  • A minimum of 3 years of experience in regulatory/Quality or related departments within the medical device industry.
  • Must be detail oriented with well-developed writing and analytical skills.
  • Ability to interpret subjective and complex aspects of specific regulations, with thorough understanding of multiple sets and tiers of associated regulations.
  • Ability to work in a self-directed manner to see issues through to completion.

Careers Contact

Please leave a message or reach out to email below with resume attached.
HR@inarimedical.com
9 Parker, Suite 100

Irvine, CA 92618

Request to Apply

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