Sr Device Engineer I

Overview

Remote
On Site
USD 136,340.00 - 176,440.00 per year
Full Time

Skills

Value Engineering
People Management
Management
Documentation
NDA
Technology Transfer
Manufacturing
Process Engineering
Problem Solving
Conflict Resolution
Root Cause Analysis
Continuous Improvement
ISO 13485
ISO 9000
Good Manufacturing Practice
Mechanical Engineering
Biomedical Engineering
Chemical Engineering
Product Development
Design Controls
Risk Management
Communication
Collaboration
MEAN Stack
Life Insurance

Job Details

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

We are seeking a highly skilled and proactive Senior Device Development Engineer to lead technical development efforts for parenteral drug-device combination products, including autoinjectors, prefilled syringes, and needle safety systems. This individual contributor role is ideal for an engineer with deep technical expertise, strong cross-functional collaboration skills, and a passion for delivering innovative, patient-centric solutions. The role may include oversight of contractors or matrixed resources but does not include direct people management.

Key Responsibilities:
  • Lead technical development activities for combination products from concept through commercialization, ensuring robust design and performance.
  • Develop and execute design control documentation, including design inputs/outputs, verification, validation, and risk management.
  • Author and review technical reports and contribute to regulatory submissions (IND, NDA, etc.).
  • Collaborate cross-functionally with Regulatory, Quality, Clinical, and Manufacturing teams to align on development strategy and execution.
  • Support technology transfer to clinical and commercial manufacturing sites, including process development and troubleshooting.
  • Drive technical problem-solving, root cause analysis, and continuous improvement initiatives.
  • Represent the device development function in internal and external technical discussions, including with suppliers and partners.
  • Stay current with industry standards and regulatory expectations, including FDA, EMA, ISO 13485, ISO 14971, and cGMP.

Basic Qualifications:

  • Doctorate OR
  • Master's and 4+ years of relevant experience OR
  • Bachelor's and 6+ years of relevant experience OR

Preferred Qualifications:

  • Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field.
  • Minimum of 6+ years (BS) or 4+ years (MS) of relevant experience in combination product development.
  • Strong understanding of design control, risk management, and regulatory standards for combination products.
  • Demonstrated ability to solve complex technical problems and contribute to strategic project decisions.
  • Excellent communication and collaboration skills; able to work effectively across functions and with external partners.

The salary range for this position is: $136,340.00 - $176,440.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

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* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.
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