Sr. Device Engineering I, Device Engineering

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

Company Overview

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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 Engineer I to support testing method development design verification and method transfer activities for medical devices and parenteral combination products including autoinjectors prefilled syringes and needlesafety systems. This individual contributor role is ideal for an engineer with strong technical fundamentals handson testing experience and the ability to collaborate effectively across development quality and manufacturing teams. The position sits within the Verification and Testing team supporting internal lab operations design verification external testing activities and method transfer to manufacturing sites.

Job Responsibilities

• Support design control activities including design verification design transfer and riskmanagement deliverables.
• Develop optimize and validate test methods for device and combinationproduct components.
• Execute design verification (DV) testing and prepare protocols data summaries and technical reports.
• Assist with method transfers between internal labs external DV labs and manufacturing sites.
• Coordinate and monitor external testing ensuring methods protocols and data meet quality and compliance standards.
• Contribute to lab operations including equipment readiness sample coordination and maintaining 5S/Kaizen practices.
• Support quality investigations (e.g. deviations CAPAs change controls) related to testing activities.
• Represent the Device Engineering function in internal meetings supplier interactions and project team forums.
• Communicate technical findings clearly with crossfunctional partners.

Basic Qualifications

Doctorate OR

Masters and 4 years of relevant experience OR

Bachelors and 6 years of relevant experience

Preferred Qualifications

• Bachelors or Masters degree in Mechanical Engineering Biomedical Engineering Chemical Engineering or related field.
• Experience in combination product development medical device testing or pharmaceutical/biotech environments.
• Handson experience with:
  • Test method development and validation
  • Design verification testing
  • Characterization and performance testing for combination products.
• Understanding of design control risk management and regulatory standards (FDA ISO 13485 ISO 14971 cGMP).
• Familiarity with relevant ISO standards (e.g. ISO 11040 ISO 11608 ISO 80369).
• Experience with statistical techniques (e.g. ANOVA Gauge R&R sample size calculations) and statistical software (JMP Minitab).
• Strong communication skills with the ability to write clear and concise technical documents.
• Demonstrated ability to troubleshoot conduct rootcause investigations and drive continuous improvement.

Ready to create possible together Hit apply.

For additional benefits information visit:

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

For jobs in the United States:

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 disabilitygenetic 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 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 theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

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.