Careers

We realize that our success as a company depends on the experience, talents and hard work of our team members. 

 Our Values
  • Our mission is to develop and enhance therapies to treat cardiovascular diseases. Our number one priority is patient safety.
  • We care deeply, work fearlessly, and change lives. We take the responsibility of the trust physicians and their patients place in us seriously and it is something that we earn each and every day.
  • We work with a sense of urgency in a competitive world with limited resources at our disposal. We understand that time is money. We plan and iterate our plans continuously to enhance our efficiency and focus. We encourage brainstorming, but execution of plans are rewarded.
  • We are data driven and challenge assumptions. We address the elephants in the room. We admit our mistakes and share lessons learned. We preserve the right to change our mind. We are persistently curious and humbled by what there is left to learn. We communicate with passion and clarity.
  • We seek to contribute to and own technological advances, product designs, and the relationships with our customers writ broadly.
  • We expect and strive to inspire the best in everyone in mind, body, and soul. We value our relationships and are positive, respectful, and open minded. We recognize the importance of family. We provide service and support to our communities as an organization and as individuals.
  • We celebrate our accomplishments regularly and aim to have fun every day!


Current Openings

BioCardia is currently seeking to fill the following positions:  
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Position Title: Clinical Trial Associate

Department: Clinical
FLSA Status: Professional; Exempt

ORGANIZATIONAL STRUCTURE:

Reports to: Clinical Trial Manager level or higher
Supervises: N/A

PURPOSE OF JOB:

Responsible for the execution and support of clinical trials and regulatory submissions that are consistent with the overall business goals worldwide. Duties will be carried out under the supervision of a Clinical Trial Manager or higher level.

MAJOR DUTIES AND RESPONSIBILITIES:

- Manage Trial Master File (TMF), site payments and regulatory documents.

- Ensure all regulatory documents and study supplies are maintained during the lifecycle of any assigned project in collaboration with the assigned field CRA(s).

- Perform ongoing reviews of TMF to assure quality of the documentation files and compliance with BioCardia SOP, GCP and ICH Guidelines.

- Prepare and review various study-related tracking systems to determine and report status of clinical trial documents (i.e., distribution, status, and retrieval)

- Responsible for the follow-up to collect outstanding and replace expired documents.

- Track device accountability logs, shipping information, and work with operations to ensure adequate supplies and investigational devices are available at clinical sites.

- Track clinical cases and work closely with accounting to enable

- Prepare clinical study binder materials (subject, regulatory, reference, and device accountability binders) and ensure timely shipment to clinical sites.

- Maintain study documentation and correspondence.

- Assist the project team in preparation for audits/inspections. May collaborate with field CRA and/or Lead CRA to address Corrective Action Plans (CAP) and ensure quality and completeness of clinical trial documentation.

- Attain thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and BioCardia SOPs.

- Design data collection forms, known as case report forms (CRFs).

- Support setting up of trial sites for executing the study, which includes ensuring each center has the trial materials, and assisting with training the site staff to trial-specific industry standards.

- Ensure compliance with applicable regulations/standards, including but not limited to FDA regulations, ISO 14155, European Medical Device and Canadian regulations.

- Support Clinical team with investigative site contracts and budget negotiations as required.

- Ensure understanding of assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across clinical sites.

- Perform other duties as assigned.

 QUALIFICATIONS:

Education and/or Job Experience:

- Bachelor's degree in a health care, other scientific discipline, or educational equivalent. Alternatively, an equivalent combination of education, training and experience may be accepted in lieu of degree.

- No fewer than two (2) years of directly related experience with site management and logistical execution of clinical trials within a medical device, pharmaceutical, biotechnology, CRO and/or healthcare setting required.

Communication Skills:

- Demonstrated ability to read, analyze and interpret complex documents.

- Demonstrated proficient written and oral communication skills in English.

- Proven ability to respond effectively to sensitive inquiries or complaints.

Special Skills, Abilities, and Requirements:

- Proficient in software applications such as Word, Excel and PowerPoint and meticulous attention to detail required.

- Proven excellent database skills are required with appropriate training.

- Physical demands: While performing the duties of this Job, the employee is regularly required to sit in front of a computer up to 80% of the time; the employee is required to stand; walk; sit, use hands to enter data in a PC, take notes, and talk or hear. The employee is occasionally required to reach with hands and arms. The employee may occasionally lift and/or move up to 25 points. Specific vision abilities required by this job include close vision and ability to adjust focus for near reading, viewing computer screen, reading written documents, etc.

Nice to Haves / Areas for Growth:

- Experience with cardiovascular trials preferred.

- Experience with eTMF systems preferred.

- Experience with legal administrative tasks preferred.

- Business Acumen: Understands business implications of decisions; displays orientation to profitability; demonstrates knowledge of market and competition; aligns work with strategic goals.

- Change Management: Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results.

- Cost Consciousness: Develops and implements cost saving measures; contributes to profits and revenue; conserves organization resources.

- Diversity: Demonstrates knowledge of EEO policy; shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; builds a diverse and cohesive workforce.

- Ethics: Sets high standard for integrity and ethical conduct for self and the organization. Conducts business in a manner that safeguards the Company’s reputation for integrity and ethical conduct. Upholds organization values. Avoids actual or potential conflicts of interest. Treats people with respect.

- Initiative: Takes independent actions and calculated risks; looks for and takes advantage of opportunities; seeks increased responsibilities; asks for and offers help when needed.

- Leadership: Inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.

- Safety and Security: Observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly.

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Position Title: R&D Engineer/Senior R&D Engineer

Department:  R&D
FLSA Status
:  Professional; Exempt

ORGANIZATIONAL STRUCTURE:
Reports to: VP of Development, Sr VP of Devices
Supervises: May supervises technicians as required

PURPOSE OF JOB: 
Use multidisciplinary engineering knowledge to design and develop innovative medical devices or components/subsystems in support of company's strategic plan.

MAJOR DUTIES AND RESPONSIBILITIES:

  • Apply broad engineering knowledge to the design, development, and planning of new products as well as product changes and enhancements which are consistent with a zero defect level as well as low product cost.
  • Manage design development process steps including obtaining and documenting input from multiple departments in Company to review design aspects for thoroughness and compliance with Quality Systems and Company procedures.
  • Ensuring design will undergo final output approval and verification before releasing concept for production.
  • Solve multidisciplinary engineering problems at the component through system level.
  • Develop test protocols and conduct testing utilizing test protocols as needed.
  • Interpret and analyze test results, generate written reports.
  • Assign work to technicians and temporary workers as needed.
  • Complete projects (including product enhancements) in a manner consistent with corporate objectives.
  • Contribute to the intellectual property position of the company via invention, development of proprietary processes, and patent applications.
  • Maintain accurate documentation of concepts, designs, drawings, and processes and ensure appropriate documents undergo the appropriate design review functions.
  • Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
  • Provide multidisciplinary engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs.
  • Resource, identify and oversee outside vendors and consultants as required.
  • Maintain QSR systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production QSR compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.
  • Provide multidisciplinary engineering support in the resolution of product complaints and/or safety issues.
  • Work with other engineering, manufacturing, clinical affairs, sales and marketing, and quality assurance staff to coordinate pilot production of new products.
  • Support company goals and objectives, policies and procedures, QSR, and FDA regulations.
  • Develop, analyze, evaluate, and modify specific design features and tolerances.
  • Create solid models and Engineering drawings documenting product designs and product test and assembly fixturing

QUALIFICATIONS:
Education and/or Job Experience:

  • Four year college degree in mechanical, biomedical, or other engineering discipline or related scientific or biomedical field.
  • 2-10 years of Catheter or related R&D work experience.

 Communication Skills:

  • Ability to communicate in English sufficiently well to support R&D responsibilities.

Special Skills, Abilities, and Requirements:

  • Hands on ability to evaluate, troubleshoot, and solve catheter design and assembly and other engineering problems
  • Hands on experience with Medical device product development, equipment or mechanical design
  • Ability and skilled in the use of 3D modeling software, such as SolidWorks, Pro Engineer, or other related Mechanical Design Software

 Nice to Haves / Areas for Growth:

  • Hands on Prototyping, Machining and Assembly skills Such as 3D printing or part machining.
  • Experience and understanding intellectual property creation and development.

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Position Title: Manufacturing/Sr Manufacturing Engineer

Department:  Operations
FLSA Status:  Professional; Exempt or Nonexempt

ORGANIZATIONAL STRUCTURE: 
Reports to: Sr. VP Devices
Supervises: Mfg Technicians as appropriate

PURPOSE OF JOB:
Provide manufacturing leadership and support in the development, manufacture and distribution of BioCardia products consistent with the Company’s Objectives and the Company Quality Policy and Quality Objectives.  Follow and maintain quality assurance standards that adhere to ISO 13485, FDA and other governmental regulations.

MAJOR DUTIES AND RESPONSIBILITIES:

  • Design and develop significant product changes and enhancements which are consistent with a zero defect level as well as low product cost. Solve complex problems at the product level.
  • Conduct testing utilizing DOE methodology and other design tools where appropriate.   Accurately generate complex written reports.
  • Hands on design, development, and implementation of manufacturing fixtures and tooling.
  • Participate in design review meetings.  Evaluate, qualify and implement design for manufacturability enhancements.
  • Complete projects including product enhancements and product transfers to contract manufacturers consistent with corporate objectives. 
  • Maintain accurate documentation of concepts, designs, drawings, and processes.
  • Provide engineering and technical support of products introduced into both the domestic and international markets.
  • Source and help manage outside vendors and consultants as required.
  • Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions. Provide support in the resolution of product complaints and/or safety issues.
  • Work with the Product Development, Manufacturing, and Quality Assurance functions to coordinate pilot production of new products.
  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA/MDD regulations.
  • Execute validation protocols, test methods, process monitoring etc, and create reports
  • Review Document Change Orders involving manufacturing product or process changes to ensure consistency with BioCardia procedures and Manufacturing requirements.
  • Lead and execute projects related to manufacturing transfer including Analysis of Operations, Cleanroom certification activities, relocation activities, etc.
  • Maintain equipment controls include EQ, calibration and PM
  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA/MDD regulations.

QUALIFICATIONS:

Education and/or Job Experience:

  • BSME or equivalent preferred.
  • 2-10 years of relevant experience in the medical device industry is required.

Communication Skills:

  • Must have excellent written and verbal communication skills.
  • Must be organized and have strong attention to detail
  • Proactive and positive Team Leader and member
  • Ability to understand, report and Proactively communicate requirements of and results of engineering support and testing as it relates to manufacturing and product development.

Special Skills, Abilities, and Requirements:

  • Knowledge of how to read common measuring tools
  • Proficiency to generate and interpret engineering drawings, protocols, specifications, and procedures
  • Ability to perform word processing and create spreadsheets, reports, working knowledge of statistical techniques.
  • Knowledge of applicable regulations and industry standards requirements. 
  • ---------------------------------------------------
  • Position Title: Quality Associate 1 
  • Department: Cell Manufacturing
  • FLSA Status: Professional; Exempt or Nonexempt Exempt
  • ORGANIZATIONAL STRUCTURE:

    Reports to: Director of Quality Assurance, Cell Manufacturing

    Supervises: n/a

  • PURPOSE OF JOB:

    The position will support ongoing cellular research and development projects being conducted in the laboratory facilities of BioCardia.

  • MAJOR DUTIES AND RESPONSIBILITIES

  • Responsibilities include:

  • Oversight of the performance of technical and complex cellular biological procedures being performed in the Cell Manufacturing Group. 

  • SOP maintenance

  • Oversight of ordering and receipt of supplies and reagents

  • Routine audits of processes and procedures

    • n/a

      Other duties as needed

       QUALIFICATIONS:

       Education and/or Job Experience:

      • Bachelor of Science or equivalent
      • Entry level laboratory quality position; training will be provided as needed

       Communication Skills:

      • Excellent communication skills and attention to detail when writing

      Special Skills, Abilities, and Requirements:

      Nice to Haves / Areas for Growth:

      Motivated, team player, ready to learn.

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    • Position Title: Clinical Research Associate (CRA) I/II
      Department: Clinical
      FLSA Status: Professional; Exempt
    • ORGANIZATIONAL STRUCTURE:
      Reports to: Senior Clinical Research Associate or higher level
      Supervises: N/A
    • PURPOSE OF JOB:
      Responsible for the execution and support of clinical trials and regulatory submissions that
      are consistent with the overall business goals worldwide. Duties will be carried out under
      the supervision of a Senior Clinical Research Associate or higher level.
    • MAJOR DUTIES AND RESPONSIBILITIES:
    • Responsible for study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits.
    • Maintain study documentation and correspondence for assigned clinical sites.
    • Manage Trial Master File (TMF), site payments and regulatory documents for assigned clinical sites.
    • Ensure all regulatory documents and study supplies are maintained during the lifecycle of any assigned project in collaboration with the assigned field CRA for assigned clinical sites.
    • Perform ongoing reviews of TMF to assure quality of the documentation files and compliance with BioCardia SOP, GCP and ICH Guidelines.
    • Ensure study-related tracking systems are kept up to date to determine and report status of clinical trial documents (i.e., distribution, status, and retrieval of study documents) for assigned clinical sites.
    • Responsible for the follow-up to collect outstanding and replace expired documents for assigned clinical sites.
    • Track device accountability logs, shipping information, and ensure adequate supplies are available at assigned clinical sites.
    • Participate in the development, review and tracking of critical study documents such as informed consent form templates
    • Assist the project team in preparation for audits/inspections.
    • May collaborate with field CRA and/or Lead CRA to address Corrective Action Plans (CAP) and ensure quality and completeness of clinical trial documentation.
    • Attain thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and BioCardia SOPs.
    • Design data collection forms, known as case report forms (CRFs).
    • Manage regulatory authority applications and approvals that oversee research.
    • Support the identification / selection of an investigator who will be responsible for the conduct of the trial at the trial site.
    • Support the identification and assessment of the suitability of facilities to be used as the clinical trial site.
    • Support setting up of trial sites for executing the study, which includes ensuring each center has the trial materials, and assisting with training the site staff to trialspecific
      industry standards
    • Ensure compliance with applicable regulations/standards, including but not limited to FDA regulations, ISO 14155, European Medical Device and Canadian regulations.
    • Support Clinical team with investigative site contracts and budget negotiations as required.
    • Assist with performing site visits to meet the site team and assess the site.
    • Ensure understanding of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites.
    • Perform other duties as assigned.
    • QUALIFICATIONS
      Education and/or Job Experience:
    • Bachelor's degree in a health care, other scientific discipline, or educational equivalent. Alternatively, an equivalent combination of education, training and
      experience may be accepted in lieu of degree.
    • Qualified candidates must have at least 1-2 year of monitoring experience.
    • Working knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harm Gidelines).
    • Preferred therapeutic area of expertise: Cardiology or related field
    • Preferred 2 years of directly related experience with site management and logistical execution of clinical trials within a medical device, pharmaceutical, biotechnology,
      CRO and/or healthcare setting required.
    • Communication Skills:
    • Demonstrated ability to read, analyze and interpret complex documents.
    • Demonstrated proficient written and oral communication skills in English.
    • Proven ability to respond effectively to sensitive inquires or complaints.
    • Special Skills, Abilities, and Requirements:
    • Proficient in software applications such as Word, Excel and PowerPoint and meticulous attention to detail required.
    • Proven excellent database skills are required with appropriate training.
    • Physical demands: While performing the duties of this Job, the employee is regularly required to sit in front of a computer up to 80% of the time; the employee is required to stand; walk; sit, use hands to enter data in a PC, take notes, and talk or hear. The employee is occasionally required to reach with hands and arms. The employee may occasionally lift and/or move up to 25 points. Specific vision
      abilities required by this job include close vision and ability to adjust focus for near reading, viewing computer screen, reading written documents, etc.
    • Experience with US and international studies a plus. This position may require up to 20-80% travel time.
    • Nice to Haves / Areas for Growth:
    • Experience with cardiovascular trials preferred.
    • Experience with eTMF systems such as Florence preferred.
    • Experience with legal administrative tasks preferred.
    • Business Acumen: Understands business implications of decisions; displays orientation to profitability; demonstrates knowledge of market and competition; aligns work with strategic goals.
    • Change Management: Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and
      supports those affected by change; monitors transition and evaluates results.
    • Cost Consciousness: Develops and implements cost saving measures; contributes to profits and revenue; conserves organization resources.
    • Diversity: Demonstrates knowledge of EEO policy; shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a
      harassment-free environment; builds a diverse and cohesive workforce.
    • Ethics: Sets high standard for integrity and ethical conduct for self and the organization. Conducts business in a manner that safeguards the Company’s reputation for integrity and ethical conduct. Upholds organization values. Avoids
      actual or potential conflicts of interest. Treats people with respect.
    • Initiative: Takes independent actions and calculated risks; looks for and takes advantage of opportunities; seeks increased responsibilities; asks for and offers help when needed.
    • Leadership: Inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
    • Safety and Security: Observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly.
    • ----------------------------------------------------------------------
    • Position Title: Quality Engineer
      Department: Quality
      FLSA Status: Professional; Exempt
    • ORGANIZATIONAL STRUCTURE:
      Reports to: Department Head Quality
      Supervises: Varied: Quality Inspectors, Document Control
    • PURPOSE OF JOB:
    • Provide Quality Engineering support in the development, manufacture and distribution of BioCardia medical device products consistent with the Company’s Quality Policy and Quality Objectives. Maintain quality assurance standards that adhere to ISO 13485, FDA and other governmental regulations.
    • MAJOR DUTIES AND RESPONSIBILITIES:
    • Provide Quality Engineering support for the development of new products including the development and execution of Quality Plans
    • Assist with the development of quality documentation including validation protocols, reports, specifications, test methods, sample plans, and related procedures. Define and specify the implementation, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy and reliability of company products.
    • Provide Quality Engineering support for commercial and R&D risk management projects.
    • Work with the Manufacturing, Clinical Affairs, Sales and Marketing, and Research and Development functions to coordinate pilot production of new products and product improvement projects.
    • Establish and maintain quality assurance procedures, provide assistance and education on the use of the procedures and ensure compliance and timeliness of the output records of the procedures.
    • Provide a tracking system for CAPAs, assisting the process owners with planning and implementing CAPAs in a timely manner, and performing effectiveness checks on implemented CAPAs.
    • Provide a tracking system for Non-Conforming Material Reports (NCMRs). Acting as the process owner, plan and implement NCMRs in a timely manner, and ensuring accurate disposition of related materials.
    • Providing a tracking system for complaints. Acting as the process owner, plan and implement complaints in a timely manner, and ensuring accurate disposition of related materials. Perform and support returned product analysis.
    • Responsible for management of supplier quality issues. Working with the suppliers, develop corrective action plans to correct any process failings and drive improvement in quality. Assist in all supplier qualification endeavors including supplier on site audit and evaluation.
    • Maintain Quality Systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post-production Quality System compliance in coordination with the Document Control, Clinical, Operations and Research and Development functions.
    • Review Document Change Orders involving product or process changes to ensure consistency with BioCardia procedures and quality system requirements.
    • Perform data analysis for quality metrics and participate in quality reviews.
    • Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to Company products.
    • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA/MDD regulations.
    • Maintain a professional, credible image with key physicians, consultants, suppliers, and co-workers.
    • Work all required overtime.
    • Perform other duties as assigned.
    • QUALIFICATIONS:
      Education and/or Job Experience:
    • BSME or equivalent preferred
    • 8-12 years of experience in the medical device industry is required.
    • Communication Skills:
    • Must have excellent written and verbal communication skills.
    • Must be organized and have strong attention to detail
      Special Skills, Abilities, and Requirements:
    • Knowledge of how to read common measuring tools
    • Knowledge of how to read and interpret engineering drawings
    • Ability to perform word processing and create spreadsheets, working knowledge of statistical techniques.
    • Knowledge of applicable regulations and industry standards
    • Nice to Haves / Areas for Growth:
    • Quality experience with cardiovascular catheter systems
    • ASQ CQE Certification/ Quality Engineering Technical Certification

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