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Technical Director, Device Engineer

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Gilead Sciences

1mo ago

  • Job
    Full-time
    Expert Level
  • Engineering
    Healthcare
  • Foster City
  • Quick Apply

AI generated summary

  • You need a relevant degree and extensive industry experience, plus skills in combination product development, strong communication, judgment, and knowledge of FDA/cGMP standards.
  • You will lead device development, manage technical evaluations, support regulatory filings, oversee technology transfer, and communicate project updates across teams.

Requirements

  • A Bachelor’s Degree in chemical engineering, bioengineering, mechanical engineering, or a related scientific field and a minimum of twelve (12) years of relevant industry experience, OR a Master’s Degree in chemical engineering, bioengineering, mechanical engineering, or a related scientific field and a minimum of ten (10) years of relevant industry experience, OR a PhD Degree in chemical engineering, bioengineering, mechanical engineering, or a related scientific field and a minimum of eight (8) years of relevant industry experience.
  • Experience with the development and commercialization of combination products.
  • Experience leading combination product development projects is desired.
  • Strong verbal, written, and interpersonal communication skills are required.
  • Must be able to write clear, concise, and error-free documents.
  • Must be able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action.
  • Working knowledge of FDA and cGMP standards for combination products.

Responsibilities

  • Lead technical development of drug delivery devices from initial concept generation through commercialization.
  • Oversee development and execution of technical evaluation plans and execution of experiments on-site as well as at contract sites.
  • Contribute to regulatory filing content related to combination products (IND, NDA, etc.).
  • Oversee technology transfer of combination product manufacturing to clinical and commercial manufacturing sites.
  • Support device product quality investigations, CAPAs and change control activities.
  • Effectively communicate ideas, project goals, and results to team members across functions and departments.

FAQs

What is the job title for this position?

The job title is Technical Director, Device Engineer.

What are the primary responsibilities of the Technical Director, Device Engineer?

The primary responsibilities include leading the technical development of drug delivery devices, overseeing the execution of technical evaluation plans, contributing to regulatory filing content for combination products, overseeing technology transfers, supporting product quality investigations, and communicating project goals to cross-functional teams.

What educational background is required for this position?

A Bachelor’s Degree in chemical engineering, bioengineering, mechanical engineering, or a related scientific field is required, along with a minimum of twelve (12) years of relevant industry experience, or a Master’s Degree with ten (10) years, or a PhD with eight (8) years of experience.

Is experience with combination products necessary for this role?

Yes, experience with the development and commercialization of combination products is required, and experience leading combination product development projects is desired.

What interpersonal skills are important for this role?

Strong verbal, written, and interpersonal communication skills are required.

What industry standards should candidates be familiar with?

Candidates should have a working knowledge of FDA and cGMP standards for combination products.

What is the salary range for this position?

The salary range is $210,375.00 - $272,250.00, with actual compensation varying based on experience, qualifications, and geographic location.

Are there additional benefits offered for this position?

Yes, the position may also be eligible for a discretionary annual bonus, stock-based long-term incentives, and a benefits package that includes medical, dental, vision, and life insurance.

How does Gilead promote diversity in the workplace?

Gilead Sciences Inc. is committed to a diverse workforce and makes employment decisions without discrimination based on various characteristics, promoting an inclusive work environment.

How can applicants request accommodations during the application process?

Applicants who require accommodations can contact ApplicantAccommodations@gilead.com for assistance.

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Gilead Sciences

Science & Healthcare
Industry
10,001+
Employees
1987
Founded Year

Mission & Purpose

The way we see it, the impossible is not impossible. It’s simply what hasn’t been achieved yet. For more than 30 years, we’ve pursued it, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases. Creating Possible drives everything we do. It’s evident in our mission and core values. This is how we built a culture of excellence that is fueled by a passion for improving lives of people around the world. For us, nothing is impossible – because of the people we work with, the communities we stand with and the partners we push forward with. Our ~12,000 employees band together through science, grit, compassion and courage to prove the impossible wrong. At Gilead, the tangible results of your contributions are evident. Where every individual matters. Where all employees can enhance their skills through ongoing development. And where we start every day with one question: “What’s next?”