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Director of Operations

​Medical Device Production Assembler - 1st, 2nd, 3rd shifts available, full time contract

Principal Engineer


Sales Representatives (Northern California, Texas: Houston)

"1099"  Independent Sales Representatives - Various Locations

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.

Director of Operations

Responsible for managing all aspects of BioTrace’s manufacturing and materials operations organization. 

Essential Duties and Responsibilities

  • Develop overall near and long term strategy for the operations organization that insures availability of high quality product that meets sales forecast and demand.

  • Develop programs, projects, goals, and metrics to lead the manufacturing organization to optimize operational performance.

  • Develop, manage and execute cost reduction and productivity improvement plans.

  • Develop policies, practices, and procedures that allow for efficient identification and resolution of production problems.

  • Develop and implement processes, technologies, and tooling needed to achieve a lean production model.

  • Manage supply chain including price negotiation, ordering, expediting, labeling, inventory and issuing parts.

  • Coordinate inspection, packaging, labelling and sterilization for commercial product.

  • Manage the maintenance of a well-organized stock inventory and product quarantine areas with appropriate segregation of all stages of materials.

  • Maintain and monitor inventory levels in accordance with the JIT philosophy.

  • Support company goals and objectives, policies and procedures

  • Develop, track and publish production performance metrics, i.e. capacity forecast, cycle time, scrap rate, yields, non-conformances, inventory and corrective actions.

  • Deliver products on time meeting quality and cost requirements.  Ensure there is an optimum production process with regards to equipment, manpower, and supply chain.

  • Accountable for compliance of manufacturing operations with specifications, SOPs, FDA regulations, EPA regulations, ISO regulations and NDAs.

  • Improve product quality and prevent customer complaints through proactive interaction with internal and external suppliers including appropriately defined component specifications, manufacturing process instructions and inspection requirements.

  • Utilize collective data from customers to enhance product quality.

  • Assess and implement product/process changes when needed to ensure quality and manufacturability is maintained.

  • Hire, develop, and manage operations team – fulltime and contractors. 

  • Establish and maintain an environment that encourages teamwork and promotes employee safety.


Preferred Skills

  • Bachelor's degree in an engineering discipline is required. Advanced degree preferred.

  • 15+ years’ experience in operations leadership role with multi discipline responsibilities (production, purchasing, etc.) in medical device industry.

  • Strong understanding of FDA and ISO medical device manufacturing requirements required.

  • Ability to manage all activities of department.

  • Ability to create, interpret and analyze statistical data and financial reports, understand and resolve technical difficulties, interface with internal engineering/technical experts and external technical representatives, and manage multiple priorities in a manufacturing environment setting.

  • Software application skills required including Solidworks and Microsoft Project.

  • Strong interpersonal, problem solving, communication and management skills are required.

  • Six Sigma certification considered a plus.

Medical Device Production Assembler - Full-Time (contract), 1st, 2nd, 3rd shifts 

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


  • 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.


  • 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


  • 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.


  • 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.



Principal Engineer



  • Support design, development, and manufacturing of temporary pacing leads from concept design through commercialization.

  • Optimize the product design and improve manufacturing processes to resolve issues in manufacturing, improve product performance, and lower cost of goods.

  • Support expansion of manufacturing operations through installation of expanded cleanroom facility requiring hands on support to establish equipment, tooling, product flow, training, and inspection requirements.

  • Assess and implement opportunities to manufacture subassemblies and finished devices through contract manufacturers and support transition of manufacturing operations as needed.

  • Lead efforts in developing and executing product verification and validation testing as well as process validation activities consistent with design changes, product requirements, risk assessments, and other product descriptive documents.

  • Develop and implement manufacturing processes, technologies, and tooling needed to achieve a lean production model.

  • Support inspection, packaging, labelling and sterilization for commercial product.

  • Collaborate with Operations, Regulatory, Marketing and Quality departments on product complaint investigations.

  • Contribute to the intellectual property position of the company via invention and patent applications.

  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA and ISO regulations.

  • Comfortable working independently in an early-stage development and manufacturing organization managing multiple priorities.


  • Bachelor's degree in engineering from an accredited four-year college or university.

  • 10 or more years in medical catheter or implantable device R&D or manufacturing experience.  AIMD experience a plus.

  • Ability to interpret and analyze statistical data, understand and resolve technical difficulties, and interface with internal and vendor engineering/technical experts.

  • Strong understanding of FDA and ISO medical device manufacturing requirements required.

  • Engineering drawing proficiency with Solidworks and PDM required.

  • Experience writing protocols, test plans, test reports and design control deliverables 

  • Experience with standard laboratory test equipment.

  • General computer skills (Microsoft Office, Project, PowerPoint, Excel, Minitab).

Sales Representatives (Northern California, Texas: Houston)



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.



  • 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



  • 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


"1099"  Independent Sales Representatives - Various Locations


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

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© 2020  by BioTrace Medical  Inc.

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