Head of Engineering

Contour Medical EP

San Francisco (CA)

Híbrido

USD 180.000 - 300.000

Jornada completa

Hace 5 días
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Descripción de la vacante

Contour Medical seeks a Head of Engineering to lead the design, development, and early manufacturing of catheter systems for cardiac ablation. The role requires hands-on leadership, direct engineering work, and ownership of the engineering plan from development to clinical use.

Reports to the CEO and is based in the San Francisco Bay Area with some remote work flexibility. The ideal candidate has 7+ years in medical device development, experience with DFMs, and proven leadership guiding a small

Formación

  • Bachelor’s or Master’s degree in Engineering or related field.
  • 7+ years of medical device product development, with 2+ years in a leadership role.
  • Hands-on product development with minimally invasive or implantable devices.

Responsabilidades

  • Lead the design, development, and verification of catheter products.
  • Own requirements, design inputs, and design verification planning for regulatory deliverables.
  • Author and review engineering protocols and reports for regulatory submission.
  • Establish and run R&D lab and early manufacturing capabilities.
  • Coordinate engineering and early manufacturing activities with CDMOs and suppliers.
  • Oversee prototypes, process development, and builds with contract manufacturers.
  • Support risk management, technical deliverables, and regulatory submissions.
  • Support preclinical and clinical studies as needed.
  • Develop, maintain and oversee engineering budget and schedule.
  • Build and mentor engineering team resources as the company grows.

Conocimientos

Leadership
Design controls
Regulatory support
Project management
Cross-functional collaboration

Educación

Bachelor’s or Master’s degree in Engineering or related field

Herramientas

CAD/SolidWorks

Descripción del empleo

About Contour Medical

Contour Medical is an early-stage medical device company developing next-generation catheter systems for cardiac ablation in electrophysiology. Our technology integrates flexible electronics, advanced catheter structures, and high-voltage pulsed field systems to enable new approaches to cardiac mapping and ablation.

The Role

We are seeking a Head of Engineering to lead the design, development, and early manufacturing of our catheter systems. The ideal candidate has built devices of this type under design controls and has led a small engineering team through a clinical milestone. This person will own the engineering plan from development builds through verification and clinical use, establish and run our in-house R&D and manufacturing capability, and manage the contract manufacturers and suppliers that support it. This is a hands-on, early-phase role that pairs technical leadership with direct engineering work. This position reports to the CEO and is based in the San Francisco Bay Area.

Key Responsibilities
  • Lead the design, development, and verification of the company’s catheter products
  • Own technical requirements, design inputs, and design verification planning, and maintenance of medical device file deliverables
  • Author and review engineering protocols and reports, including feasibility, design analysis, and verification reports suitable for regulatory submission and audit
  • Establish and run the company’s R&D lab and early manufacturing capability, including assembly, fixtures, and test equipment
  • Coordinate engineering and early manufacturing activities across the organization and with contract development suppliers and consultants
  • Work with contract manufacturers and component suppliers on prototypes, process development, and builds, managing scope, schedule, and cost
  • Support risk management activities, produce technical deliverables, and provide support for regulatory submissions
  • Support preclinical and clinical studies as needed
  • Develop, maintain and oversee engineering budget and schedule
  • Build, mentor, and manage engineering team resources as the organization evolves
Required Qualifications
  • Bachelor’s or Master’s degree in Engineering or related field
  • Minimum of 7 years of medical device product development experience, with at least 2 years in a leadership role
  • Hands-on product development experience with minimally invasive or implantable devices built from polymer and metal components (such as catheters, delivery systems, leads, or electrode-bearing disposables)
  • Experience with several of the following: extruded and braided tubing, bonded and sealed assemblies, flexible circuits, and electrode integration
  • Experience applying design for manufacturability principles (DFM) and developing manufacturing and assembly processes for new devices
  • Experience developing benchtop test methods and fixturing, and planning or conducting design verification
  • Experience managing an R&D lab and/or in-house manufacturing
  • Experience managing contract manufacturers or CDMOs
  • Proficiency with CAD/SolidWorks
  • Prior experience in a startup or early-stage environment
Preferred Qualifications
  • Direct experience developing catheter systems, particularly for cardiac electrophysiology mapping and/or pulsed field ablation
  • Demonstrated leadership in successful product development milestones
  • Technical writing supporting regulatory submissions or associated deliverables
  • Based on San Francisco Bay Area, CA, with some flexibility for remote work. Travel may be required up to 20%. Relocation assistance negotiable.
Compensation Range
  • Stock Options
Please note:

Applicants must be authorized to work in the United States. We are unable to sponsor or transfer employment visas for this role.

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