Careers

We're Growing!

If you have interest in opportunities at BioTrace Medical, please submit your resume to info@biotracemedical.com 

OPERATIONS

Medical Device Lead Assembler - Full-Time, 2nd shift

​Medical Device Production Assembler - 1st and 2nd shifts available

Quality System Specialist

COMMERCIAL

Sales Representative (Northern & Southern California)

"1099"  Independent Sales Representative - Florida

COVID-19 Considerations: BioTrace Medical adheres to all recommended COVID-19 practices: masks required, social distancing, staying home when sick, quarantining after OUS travel, etc.

 

Medical Device Lead Assembler - Full-Time, 2nd shift

 

Responsible for supervision of the production staff and for achieving BioTrace’s production build plan in compliance with company quality systems, and also contribute as part of the manufacturing team building devices.  Has the authority to identify and record problems relating to product component design, device manufacture, and recommend solutions.  Fabricate BioTrace pacing lead sub-assemblies and final lead assembly per established Manufacturing Process Instructions.

 

GENERAL DUTIES AND RESPONSIBILITIES:

  • Supervise production staff while also performing production operations.

  • Train new production hires to released procedures and existing staff to newly revised procedures.

  • Assure all required records to support builds are properly documented.

  • Control materials coming into production areas to assure traceability.

  • Segregate all non-conforming parts/products.

  • Manage Controlled Room daily cleaning.

  • Insure line clearance at the beginning and end of each new lot.

  • Monitor and report on production status on daily basis.

  • Monitor production and test equipment to assure timely calibration.

  • Monitor and ensure that adequate equipment is in place to perform the process efficiently and with highest quality.

  • Perform DHR review.

  • Adhere to BioTrace Medical’s Quality Policy and Good Manufacturing Practices.

 

SPECIFIC COMPETANCIES

  • Demonstrated manual proficiency working under a microscope (10x-40x) to prepare and assemble complex and precision catheter components and sub-assemblies, and final catheter assembly.  Relevant experience:

    • Assembly of interventional medical devices.

    • Assembly of guide wires, interventional catheters, or pacemaker products.

  • Demonstrated examples of working with the following tools and processes:

    • Assembly devices under 10-40X stereo microscope

    • Micro-crimpers and trimming operations

    • UV-bonding adhesives and UV light source

    • Hypotube hole cutters

    • Preparation of micro-hypotube components for assembly into the final catheter (holding & cutting to length using pin vices and Dremel tool)

  • Experience using

    • Analog and digital calipers

    • UV cure systems

    • Electronic flow dispensing system

 

EXPERIENCE/EDUCATION REQUIREMENTS:

  • High school diploma required.

  • Minimum of 7 years of industry experience in the fabrication of interventional medical devices.

 

8OTHER QUALIFICATIONS:

  • Assemblers at this level will be expected to have extensive understanding of medical device manufacturing, quality systems for process and material traceability, and provide leadership and support to all assemblers.

  • Train and cross-trains new employees.

  • Working knowledge of GMP (Good Manufacturing Practices) and cleanroom protocol.

  • Excellent manual dexterity.

  • Flexibility with respect to work hours.

  • Proficient spoken and written English.

 

 

Medical Device Production Assembler - 1st and 2nd shifts available


Performs fabrication of BioTrace pacing lead sub-assemblies and final lead assembly per established Manufacturing Process Instructions. Adheres to established company timelines for all product builds

GENERAL DUTIES AND RESPONSIBILITIES:

  • Perform strict adherence to established Manufacturing Process Instructions. Recording of accurate information into the Lot History Record for all product builds.

  • Provide open communications and feedback to both Operations Director and V.P. of R&D related to progress of all product builds, and any issues that may affect the quality and/or progress of each product build, consistent with the company timeline.

  • Identify manufacturing and/or process challenges to improve fabrication techniques, quality or efficiency of product builds.

  • Adhere to BioTrace Medical’s Quality Policy and Good Manufacturing Practices.

  • Support company goals and objectives, policies and procedures, the QSR, and other FDA/MDD regulations.

SPECIFIC COMPETENCIES:

  • Demonstrated manual proficiency working under a microscope (10x-30x) to prepare and assemble complex and precision catheter components and sub-assemblies, and final catheter assembly at the scale of a 6F catheter (0.080” catheter diameter) or smaller. Relevant experience :

  • Assembly of intravascular guide wires (0.014” and/or 0.035”)

  • Assembly of PTCA or PTA catheters

  • Assembly of atherectomy catheters

  • Demonstrated examples of working with the following tools and processes:

  • Micro-crimpers and crimping operations

  • UV-bonding adhesives and UV light source

  • Hypotube hole cutters

  • Assembly of micro-subassemblies into the scale of a 6F catheter system

  • Preparation of micro-hypotubes for assembly into the final catheter (holding & cutting to length using pin vices and Dremel tool)

  • Expansion of catheter lumen using heat gun and mandrels

  • Experience using

  • Dremel tools

  • Analog and digital calipers

  • UV cure systems

  • Electronic flow dispensing system

EXPERIENCE/EDUCTAION REQUIREMENTS:

  • Minimum 5 years medical device industry experience in the fabrication of micro-catheters preferable.

  • Some experience in Research and Development desirable.

  • High school diploma required.

OTHER QUALIFICATIONS:

  • Working knowledge of GMP (Good Manufacturing Practices) and cleanroom protocol.

  • Excellent manual dexterity

  • Flexibility with respect to work hours as some evening/weekend work may be required.

  • Proficient spoken and written English

  • Must sign BioTrace confidentiality agreement.

 

 

Quality System Specialist

DUTIES AND RESPONSIBILITIES:

  • Maintains master document control system via the Document Change Order (DCO) process. Ensures timely DCO review, approval, incorporation, checking, and release.

  • Administers the project document control system to support new product development activities.

  • Maintains external document control system to ensure that all external documents referenced in controlled documents are available.

  • Prepares and revises controlled documents in accordance with the standard formats. Document types include specifications, procedures, forms, plans, protocols, and reports using word processing and spreadsheet software.

  • Maintains various lists, logs and tracking systems related to documents and records utilizing spreadsheet software.

  • Releases approved documents including copying, stamping, and distribution. Retrieves superseded and obsolete document revisions to prevent inadvertent use.

  • Archives, organizes, and secures various quality records including Design History Files, Device History Records, and Quality System Records to provide for reliable and efficient retrieval.

  • Inspects products in accordance with written procedures, statistical sampling plans, engineering drawings and specifications as assigned. Documents nonconforming products as appropriate.

  • Maintains various quality system logs and records.

  • Maintains and operates inspection and test equipment (e.g., optical measurement system, micrometer, caliper, pin gages, microscope, tensile tester, analytical chemistry equipment).

  • Provides input regarding inspection methods and quality procedures.

  • Ensures traceability of components and products.

  • Maintains quality assurance filing systems.

  • Receives incoming materials and supplies, performing inspections as required.

  • Establishes and maintains Standard Operating Procedures and Forms related to areas of responsibility.

  • Works in accordance with quality system procedures
     

PREFERRED SKILLS:

  • Good verbal and written communication skills including ability to prepare written procedures and reports.

  • Good organizational and planning skills.

  • Good math skills.

  • Good hand/eye coordination, manual dexterity, color vision, and visual acuity (corrected if necessary).

  • Working knowledge of electronic file management tasks using MS Windows, MS Explorer software.

  • Working knowledge of word processing (MS Word), spreadsheet (MS Excel), and document management (Adobe Acrobat) software. 

                                            
PREFERRED QUALIFICATIONS (Education, Experience, Specialized Training):

  • High School diploma or equivalent certification is required.

  • Minimum three years experience in Quality Assurance/Control or Document Control in a medical device manufacturing environment.

  • Proficient in using software such as MS Word/Excel/PowerPoint and Adobe Acrobat.

  • Experience in reading and interpreting engineering drawing and specifications.

  • Experience with using dimensional/visual inspection equipment including microscopes required.
     

 

Sales Representative (Northern & Southern California)

 

POSITION SUMMARY:

Reporting to the VP Sales, the Sales Representative will be responsible for the execution of all sales strategies and activities as assigned for an early stage medical device company.

 

RESPONSIBILITIES:

  • Achievement of sales quotas as assigned

  • Education of customers on the merits and proper clinical usage of company products by giving presentations and demonstrations in a wide variety of forums and formats, including case coverage.

  • Establishment of business working relationships with key physicians, clinical support staff, and supply chain personnel to effect initial evaluations and continued utilization

  • Proactive assessment, clarification, and validation of customer needs on an ongoing basis.

  • Reporting of field activity as defined by Company management using CRM tools

  • Maintenance of territory sales forecast 

  • Support of KOL development and clinical marketing initiatives

  • Attendance at meetings, courses, and tradeshows as assigned

  • Maintenance of assigned sales samples, stock, and Company property

  • Adherence to Company policies and procedures and compliance with applicable quality/regulatory requirements

 

REQUIRED QUALIFICATIONS:

  • BA or BS degree required; MA or MS degree a plus

  • 5+ years of medical device sales/field clinical support experience in a cardiovascular early stage start-up company calling on the cath lab/ EP Lab

  • Experience in structural heart and/or interventional cardiology  and/or Electrophysiology

  • Demonstrated selling skills, technical aptitude, work ethic and the ability to build positive working relationships are essential

  • Proven track record of sales success, consistent career growth and assignment of additional responsibilities within current position

 

COMPENSATION

  • Base salary and commission tied to sales and quantitative strategic account metrics

  • Stock options

  • Health, dental, 401(k)

"1099"  Independent Sales Representative - Florida

 

Responsible for the achievement of sales objectives of a specified territory under the direction of the VP of Sales. Promote the company’s products to physicians, staff and educate customers on the safe and effective use of these devices. 

  

  • Identify sales opportunities based on patient and physician needs and tailor product recommendations to facilitate excellent patient and procedural outcomes

  • Develop new business opportunities and increase adoption and utilization with established customers – cultivate new business 

  • Develop and execute strategic plans for territory

  • Provide expert and comprehensive guidance on the use of devices and/or products to enable physicians and staff to reach expert proficiency and achieve excellent patient outcomes

  • Sell company’s Tempo Lead by interacting with established customers, i.e. physicians, other healthcare providers, hospital administration, and materials management, with physicians as the primary focus and develop prospects

  • Establish and strengthen customer relationships including those with key opinion leaders

  • Ensure that clinicians are provided with adequate technical, product and in-service support and that staff are trained properly on the safe and effective use of products

  • Educate physicians on medical literature, concepts and procedures related to company’s products

  • Prepare and negotiate price offers/contracts in collaboration with senior management 

  • Communicate sales activities and any relevant information to VP of Sales routinely

 
 
 
 
 

BioTrace Medical, Inc. is a growing commercial stage venture-backed company dedicated to reinventing temporary pacing to improve patient outcomes and reduce hospital costs.. BioTrace Medical’s Tempo Temporary Pacing Lead is designed for safer, more secure and stable pacing to reduce intra procedural complications, including perforation and valve embolization. In addition, the Tempo Lead allows patients to ambulate sooner after procedures such as TAVR and TMVR, accelerating recovery times, and enabling patient transfer directly to a step-down or telemetry unit instead of an ICU or CCU. With US FDA clearance and CE certification, the Tempo Lead is the only active fixation temporary pacing lead available in the world. The Tempo Lead’s unique design – featuring novel retractable stabilizer loops and a soft tip – mitigates the risks of dislodgment and perforation and ensures stability during rapid pacing.

BioTrace Medical Inc.

3925 Bohannon Drive Suite 200

Menlo Park, CA  94025

(650) 779-4999

info@biotracemedical.com

  • LinkedIn Social Icon
  • Twitter

© 2020  by BioTrace Medical  Inc.

APM003-01 Rev N