Careers at Claret Medical

Claret Medical was founded with the realization that one stroke is one too many, and that any stroke has a disastrous impact on a patient’s life and family. With that vision, Claret Medical has developed the Sentinel® Cerebral Protection System, a medical device that captures and removes debris during Transcatheter Aortic Valve Replacement (TAVR), and offers protection against the risk of stroke during the procedure and shortly thereafter.

Located in picturesque Santa Rosa, in the heart of Sonoma County’s wine country in Northern California, Claret Medical offers excellent career opportunities for those interested in making a difference in the lives of patients with cardiovascular disease.

We are currently growing! Claret Medical fosters a team atmosphere and a culture of innovation and continuous improvement. As part of our team you will have the opportunity to work with top technical professionals in bringing cutting-edge technologies to market. If you want to move forward in your career, Claret Medical may have the perfect opportunity for you!

To learn more about our career opportunities, see our current openings below and apply by sending your resume to careers@claretmedical.com.

Administrative Assistant III

The primary focus of this position is providing complex administrative support for individuals and/or the site location in Santa Rosa. You will work under limited supervision with general instructions given on new assignments.

Your responsibilities:

  • Performs general administrative duties that may include photocopying, coordinating meetings/appointments, typing, faxing, ordering/maintaining supplies, arranging travel, preparing and/or sorting mail.
  • Serves as a point of contact for external visitors and vendors. Contacts are frequently within and outside the organization and involve obtaining or providing information on matters of moderate importance to the organization and may be of a sensitive nature.
  • Answers complex functional questions that may require additional research and follow-up.
  • Viewed as key functional resource.
  • Anticipates and coordinates projects/assignments, organizes own schedule, and that of others, to meet deadlines. May gather and prepare data in preparation of upcoming projects; identifies future needs to complete projects.
  • Makes decisions using independent judgment under only general guidelines.
  • Translates thoughts into documents (letters/memos/presentations, etc.) using existing material; ensures documents are logical and complete as well as accurate in grammar and spelling; makes suggestions for improvements in existing communications.

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To apply contact us at careers@claretmedical.com.

Director, Quality

You will lead a team of Managers, Engineers, Technicians and other QA professionals to ensure the efficient production / assembly, complaint investigation, and quality system execution in accordance with Global / site procedures in full compliance to all GMP/QSR practices and standards as defined by the Food and Drug Administration, ISO Standards, and other regulatory bodies. This position collaborates with R&D and Manufacturing Engineering on new product introductions and sustaining projects.

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To apply contact us at careers@claretmedical.com.

Field Clinical Specialist

Claret Medical is looking for a highly motivated & experienced Field Clinical Specialist based in Salt Lake City, Denver, or Seattle. The ideal candidate will have 4+ years of industry experience in clinical support of interventional cardiology or radiology procedures with previous TAVR or structural heart industry experience desirable.

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To apply contact us at careers@claretmedical.com.

 Maintenance Technician

The incumbent in this position will maintain facilities, facilities systems and equipment in order to provide a safe, efficient and comfortable workplace. Responsibilities include operation, repair, and preventative maintenance of all building facilities and equipment; move and installation of equipment and or furniture; and other related duties.

Your responsibilities:

  • Performs plant and/or office facilities maintenance duties such as furniture moving, maintenance of office equipment, simple electrical projects, spot painting or cleaning, light construction or exterior clean up.
  • Performs routine repairs and maintenance of plant and/or office facilities and equipment by using hand or power tools as required.
  • Sets up and operates all tools and equipment necessary to perform assigned work.
  • Makes routine, periodic, or special inspections to determine repair and maintenance work necessary to prevent breakdowns of facilities, machinery, and equipment.
  • Works with manufacturing or process engineering in the installation or repair of building plumbing and wiring required in the production process.
  • Tests, inspects, troubleshoots, and repairs machines and equipment and reports problems to supervisor as appropriate.

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To apply contact us at careers@claretmedical.com.

Process Development Technician – 2 positions

About the role:

This role’s primary commitment is to assist project teams in the development of new medical device products and their associated manufacturing processes. Primarily directed by engineers to create and refine the necessary machinery, tooling, documentation, and relationships to successfully bring these new products to market in a regulated industry.

Your responsibilities:

  • Collects and organizes process capability and product performance data.
  • Facilitates pre-production process development product builds and/or coordinates pilot product builds.
  • Assists process development engineer/team in equipment development (e.g., fixtures, process mechanization, and automation activities).
  • Assists in writing equipment qualification protocols and performing equipment qualifications.
  • Understands and maintains basic process documentation.
  • Interfaces with other departments to obtain/deliver materials and information.
  • Generates new ideas for improving processes.
  • Provides floor support for new product builds (e.g., troubleshoots equipment and manufacturing problems).

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To apply contact us at careers@claretmedical.com.

Product Builder, Manufacturing

Responsible for processing and assembling high quality medical devices while minimizing scrap. There are open positions for the 1st and 2nd shift in Santa Rosa, California.

Duties and responsibilities:

  • Process and assemble medical devices in accordance with approved manufacturing procedures in a cleanroom.
  • Perform in-process quality checks on sub-assemblies and finished product.
  • Utilize small hand tools, calibrated instruments, measurement equipment, microscopes, and test fixtures.
  • Maintain accurate records/documentation related to quality, work in progress, test results, labor (e.g. timecards), and special projects.

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To apply contact us at careers@claretmedical.com.

Quality Engineer II

This position will develop, establishes and maintains quality engineering methodologies, systems, and practices which meet Boston Scientific customer, and regulatory requirements in support of product development. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.

Your responsibilities:

  • Leads and/or participates in project teams coordinating the quality efforts of engineers, technicians and other professionals of various disciplines/departments to design, develop, and continuously improve medical device products. Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part of a major project or in a total project of moderate scope.
  • Performs work which involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of standard materials, and complex data analysis.
  • Facilitating and performing internal QA audits.
  • Performing statistical analysis to assess cost of, and determine the responsibility for products or materials that do not meet required standards and specifications;
  • Create, maintain and update PFMEAs, Test method validations, Visual Standards, Quality Control Inspections.
  • Participate in MRB as appropriate and partner and assist manufacturing with the implementation and maintenance of SPC.
  • May specialize in one of the areas of in-process inspection, design of product evaluation, and/or research and development as they apply to quality control.

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To apply contact us at careers@claretmedical.com.

Quality Systems Engineer II

This position will provide quality assurance oversight for the Operations Group to ensure compliance with all applicable regulations including documentation reviews, discrepancy system management, audit support, technical, projects, and documentation.

Your responsibilities:

  • Facilitate development and maintenance of the quality management system according to ISO, MDD and FDA requirements.
  • Maintain the CAPA system to ensure proper notification, impact assessment, root cause analysis, investigations and effectiveness verifications to ensure all requirements are met.
  • Perform complaint handling, including root cause analysis, investigations, corrective action determinations, and as appropriate, adverse event determinations and reporting
  • Provide system administration duties and technical interface with consultants to support and maintain the Manufacturing Pro database, including software changes and re-validation activities.
  • Perform audits/assessments internally and of suppliers for compliance to quality system and regulatory requirements. Support internal and external audits as well as follow through on audit responses.

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To apply contact us at careers@claretmedical.com.

Senior Buyer

The Senior Buyer is responsible for procuring raw materials, OEM components, capital equipment, tooling, supplies and services, to ensure a 100% customer service level, while achieving the targeted inventory turn objective. They are also responsible to strike an optimal balance between cost, quality, delivery and service in a fast-paced environment. The Senior Buyer is responsible to thoroughly understand the commodities and products they support, to give the organization a competitive advantage.

Your Responsibilities Include:

  • Materials Administration: Generates adjusts and expedites purchase orders based on the MRP (material requirements planning) along with pertinent information being used to run the business that maybe more current, i.e. schedule adherence, SIOP, COP; Generates buy action based on authorized spending amount; Coordinates with the Supply Network Planners to maintain optimal service levels and determine the proper priorities for material support; Tracks and monitors purchase orders, keeping informed of any problems/delays and communicates any impacts/constraints to the Supply Network Planner, manufacturing manager/supervisor or other discipline impacted by the change; Supports material needs for the product development process to ensure BSCs competitive first to market strategy; Generates on-going cost savings through the VIP Process; Participates on PDP (Product Development Process) teams for sourcing material; Responsible to mentor buyer and associate buyer levels; Manages the most complex commodities and/or responsibilities; Displays leadership by initiating change ideas and driving implementation.
  • Supplier Management: Monitors and communicates quality and delivery performance to the supplier; Responsible to resolve supplier related problems (works closely with BSC Global Sourcing Team and suppliers to assure a positive and professional relationship, always establishing and maintaining open lines of communication.); Maintains awareness of market trends pertaining to their responsibility.
  • Total Quality: Adheres to CGMP and FDA requirements; Reviews and approves all raw material document change orders; Maintains accurate purchasing master data, AVL, info record, etc.; Interfaces with Engineering, Planning, Supply Network Planning and Quality to ensure timely throughput and proper prioritization of materials received.

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To apply contact us at careers@claretmedical.com.

Senior Document Control Analyst

This position will provide quality systems expertise to ensure adherence to regulations, company policies, and internal procedures in all phases of product life cycle with particular focus on documentation and configuration management, quality record archival and maintenance, employee training, quality system integration, and external standards. Some of the responsibilities of this position are as follows:

  • Administer, improve, and maintain the company’s Document Control and Training Management Systems.
  • Lead integration of documentation and record control systems into quality management software modules
  • Create and maintain all controlled document files, both hard copy and electronic versions, including associated logs. Maintain security controls on all documents
  • Manage and track quality system employee training program
  • Manage documentation revision related to reviewing and writing policies, procedures, assembly instructions, and other controlled documents
  • Review manufacturing documentation of in-process work, incoming materials, and finished goods in the manufacture of medical devices
  • Collect and trend quality metrics in the areas of document change requests, training compliance, etc. in support of Management Review meetings

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To apply contact us at careers@claretmedical.com.

Senior Quality Engineer

The incumbent in this position will provide leadership, develop, establish and maintain quality engineering methodologies, systems, and practices which meet Boston Scientific customer and regulatory requirements. You will serve as a Quality representative to improve awareness, visibility and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. You will also provide focused quality engineering support within new product development, operational, or system/services support.

Your Responsibilities as a Sr. Engineer:

  • Provides leadership role on the development of risk management file deliverables. (FMEA, Hazard Analysis, etc)
  • Provides leadership role on championing departmental or cross-functional engineering initiatives.
  • Provides project direction, coaching, and mentoring for engineering and technical team personnel.
  • Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
  • Mentor for technical guidance for identifying and resolving quality issues.
  • Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.

See full description >

To apply contact us at careers@claretmedical.com.

Senior R&D Engineer

As part of our team you will have the opportunity to work with top technical professionals in bringing cutting-edge technologies to market. Some of the position responsibilities for the Sr. R & D Engineer include the following:

  • Research, design, and develop new products from initial design to market release.
  • Conduct data analysis using statistical tools such as JMP, Minitab, and/or Excel.
  • Utilize advance experimental design methodologies (such as DOE’s) with significant complexity and execute test protocols and reports to facilitate the design of the medical devices.
  • Lead and manage complex projects.

See full description >

To apply contact us at careers@claretmedical.com.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Click here for the Indication, Contraindications, Warnings, and Precautions.