Senior Device Engineer

Ventura Solutions LLC; San Diego (CA); Presencial; USD 120.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical and dental insurance

Paid vacation time

401(k) after 90 days

Descripción de la vacante

Ventura Solutions LLC is seeking an experienced Senior Systems Engineer to support client device development programs focused on autoinjector and combination products. The successful candidate will lead day‑to‑day development activities, manage design control deliverables, coordinate external partners, and ensure program objectives are met.

Ideal candidates bring deep hands‑on medical device experience and can independently manage design controls, risk management, technical documentation, and

Formación

• Bachelor's degree in Mechanical or Biomedical Engineering.
• 7–10 years of device or combination product development experience.
• Hands-on autoinjector development and commercialization experience.
• Experience with design controls and risk management.
• Willingness to perform detailed execution work in addition to strategic input.
• Strong project management and cross-functional coordination.
• Excellent written and verbal communication.

Responsabilidades

• Support autoinjector and combination product development activities.
• Develop and maintain integrated project schedules and Gantt charts.
• Coordinate activities across device vendors, fill‑finish partners, assembly sites, and other suppliers.
• Prepare and manage design control and risk management deliverables.
• Draft development plans, verification plans, and supporting technical documentation.
• Manage day‑to‑day execution of assigned programs while receiving strategic direction from client leadership.
• Work independently on design control processes and deliverables.
• Communicate effectively across technical and cross‑functional teams.

Conocimientos

Project management

Communication skills

Cross-functional coordination

Hands-on execution

Design controls

Risk management

Educación

Bachelor's in Mechanical/Biomedical Engineering

Herramientas

Gantt charts

Descripción del empleo

We are seeking an experienced Senior Systems Engineer to support client device development programs focused on autoinjector and combination products. The successful candidate will serve as an extension of the client team, leading day-to-day development activities, managing design control deliverables, coordinating external partners, and ensuring program objectives are achieved.

The ideal candidate brings deep hands‑on experience in medical device and combination product development, with the ability to independently manage design control activities, risk management deliverables, technical documentation, and cross‑functional project execution while contributing to overall program strategy.

Responsibilities

• Support autoinjector and combination product development activities across multiple programs.
• Develop and maintain integrated project schedules and Gantt charts.
• Coordinate activities across device vendors, fill‑finish partners, assembly sites, and other suppliers.
• Prepare and manage design control and risk management deliverables.
• Draft development plans, verification plans, and supporting technical documentation.
• Manage day‑to‑day execution of assigned programs while receiving strategic direction from client leadership.
• Work independently on design control processes and deliverables.
• Communicate effectively across technical and cross‑functional teams.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Approximately 7–10 years of relevant experience in device or combination product development.
• Direct, hands‑on autoinjector development and commercialization experience.
• Experience with combination product design controls and risk management.
• Willingness and ability to perform detailed, hands‑on execution work in addition to any strategic input.
• Strong project management skills, including schedule development and cross‑functional coordination.
• Strong written and verbal communication skills.

Location

• On‑site in San Diego, CA

Employment Type

• W2 Contract

Benefits for W2

• Medical and dental insurance
• Paid vacation time
• 401(k) after 90 days

About Ventura Solutions

Ventura Solutions is a reputable end‑to‑end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on‑board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

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