29 days old

Sr Engineer

Amgen
Thousand Oaks, CA 91360
  • Job Code
    116464101
  • Jobs Rated
    8th
Amgen

Job ID: R-89647
Location: Thousand Oaks, CA, US 91360

In support of Amgen's mission to serve patients, the Development Product Engineering Organization at Amgen is a diverse team responsible to identify, develop, commercialize, and continuously improve drug-device combination products to optimize the patient experience.

The Sr. Development Engineer works as part of a multi-disciplinary cross-functional program team to create the technical content and meet performance and quality deliverables for Drug-Device Combination Products from concept through commercial entry. The Development Engineer authors design requirements, test methods, test reports, and technical analyses. The successful candidate establishes well-supported insights for the feasibility of concept stage and development stage solutions to serve user needs and the needs of the pipeline portfolio. The successful candidate will be responsible for technical program advancement leveraging a range of program tools, design characterization studies, design reviews, and verification methods. The successful candidate helps translate user needs into system requirements and solutions. S/he ensures that the quality targets are satisfied and helps identify and reduce technical risks on the program.

Responsibilities
  • Support the optimal design of complex, large scale systems through consideration of the system and its contributing components.
  • Develop requirements and use cases for compliance to standards
  • Support analysis of investment in new drug delivery technologies through demonstration that proposed solutions can feasibly achieve user needs in service of Amgen's product pipeline.
  • Develop and execute system verification and validation plans & procedures.
  • Review completed design work.
  • Develop and exploit structured, efficient approaches to analysis and design to solve complex engineering problems.
  • Communicate effectively at multiple levels regarding project status, risks, issues, and accomplishments.
  • Utilize project planning and monitoring methods to ensure timely completion.
  • Ensure compliance to Regulatory and Quality requirements when authoring design inputs, generating design outputs, and conducting technical reviews.
  • Create and review advanced computer simulations to support design & development efforts.
  • Interface with the commercial device engineering organization to ensure adequate sustainment and enhancement of products throughout their lifecycle.
  • As part of the team working on device platforms, create architecture to support variations of the platform and system deliverables packages
  • Successfully influences outcomes, communicates with all levels of the organization, facilitates development of solutions to critical business issues, and effectively define objectives to enable effective metrics generation and reporting

Basic Qualifications

Doctorate Degree

OR

Master's Degree & 3 years of Engineering and/or Medical Device experience

OR

Bachelor's Degree & 5 years of Engineering and/or Medical Device experience

OR

Associate's degree & 10 years of Engineering and/or Medical Device experience

OR

High school diploma/GED & 12 years of Engineering and/or Medical Device experience

Preferred Qualifications
  • 6+ years industry experience for development of drug-device combination products through commercial entry
  • Strong working knowledge of
    • US Good Manufacturing Practices - 21CFR820
    • Quality Management - ISO 13485
    • EU Medical Device requirements - Council Directive 93/42/EEC
    • Medical Electrical Equipment - EN 60601
    • ISO 14971 and ISO 62304
  • Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
  • Strong problem solving, risk assessment, and risk management skills
  • Ability to converse technically with mechanical, electronic, software, and quality engineers
  • Capable of working on multiple projects in a deadline driven environment
  • Strong oral and written communication skills, decision making and presentation and organization skills, to collaborate with Hardware, Software, Systems Engineers, and domain experts in the area of design and safety risk analysis.
  • Proven ability to collaborate with various design/cross-functional teams such as clinical, patient safety and influence product development teams to drive system safety into product design.
  • Demonstrated ability to navigate through ambiguity and provide a structured problem solving approach
  • Organizational savvy and presence to build effective relationships across functions
  • Track record of building or participating as a member of high performing teams
  • Working knowledge of MS Office tools


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

PI116464101

<b>Amgen</b><br/><br/><b>Job ID: </b>R-89647<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>In support of Amgen's mission to serve patients, the Development Product Engineering Organization at Amgen is a diverse team responsible to identify, develop, commercialize, and continuously improve drug-device combination products to optimize the patient experience.<br><br>The Sr. Development Engineer works as part of a multi-disciplinary cross-functional program team to create the technical content and meet performance and quality deliverables for Drug-Device Combination Products from concept through commercial entry. The Development Engineer authors design requirements, test methods, test reports, and technical analyses. The successful candidate establishes well-supported insights for the feasibility of concept stage and development stage solutions to serve user needs and the needs of the pipeline portfolio. The successful candidate will be responsible for technical program advancement leveraging a range of program tools, design characterization studies, design reviews, and verification methods. The successful candidate helps translate user needs into system requirements and solutions. S/he ensures that the quality targets are satisfied and helps identify and reduce technical risks on the program.<br><br><b>Responsibilities</b><br><ul><li>Support the optimal design of complex, large scale systems through consideration of the system and its contributing components.</li><li>Develop requirements and use cases for compliance to standards</li><li>Support analysis of investment in new drug delivery technologies through demonstration that proposed solutions can feasibly achieve user needs in service of Amgen's product pipeline.</li><li>Develop and execute system verification and validation plans & procedures.</li><li>Review completed design work.</li><li>Develop and exploit structured, efficient approaches to analysis and design to solve complex engineering problems.</li><li>Communicate effectively at multiple levels regarding project status, risks, issues, and accomplishments.</li><li>Utilize project planning and monitoring methods to ensure timely completion.</li><li>Ensure compliance to Regulatory and Quality requirements when authoring design inputs, generating design outputs, and conducting technical reviews.</li><li>Create and review advanced computer simulations to support design & development efforts.</li><li>Interface with the commercial device engineering organization to ensure adequate sustainment and enhancement of products throughout their lifecycle.</li><li>As part of the team working on device platforms, create architecture to support variations of the platform and system deliverables packages</li><li>Successfully influences outcomes, communicates with all levels of the organization, facilitates development of solutions to critical business issues, and effectively define objectives to enable effective metrics generation and reporting<br></li></ul><br><b>Basic Qualifications</b><br><br>Doctorate Degree<br><br>OR<br><br>Master's Degree & 3 years of Engineering and/or Medical Device experience<br><br>OR<br><br>Bachelor's Degree & 5 years of Engineering and/or Medical Device experience<br><br>OR<br><br>Associate's degree & 10 years of Engineering and/or Medical Device experience<br><br>OR<br><br>High school diploma/GED & 12 years of Engineering and/or Medical Device experience<br><br><b>Preferred Qualifications</b><br><ul><li>6+ years industry experience for development of drug-device combination products through commercial entry</li><li>Strong working knowledge of<ul><li>US Good Manufacturing Practices - 21CFR820</li><li>Quality Management - ISO 13485</li><li>EU Medical Device requirements - Council Directive 93/42/EEC</li><li>Medical Electrical Equipment - EN 60601</li><li>ISO 14971 and ISO 62304</li></ul></li><li>Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations</li><li>Strong problem solving, risk assessment, and risk management skills</li><li>Ability to converse technically with mechanical, electronic, software, and quality engineers</li><li>Capable of working on multiple projects in a deadline driven environment</li><li>Strong oral and written communication skills, decision making and presentation and organization skills, to collaborate with Hardware, Software, Systems Engineers, and domain experts in the area of design and safety risk analysis.</li><li>Proven ability to collaborate with various design/cross-functional teams such as clinical, patient safety and influence product development teams to drive system safety into product design.</li><li>Demonstrated ability to navigate through ambiguity and provide a structured problem solving approach</li><li>Organizational savvy and presence to build effective relationships across functions</li><li>Track record of building or participating as a member of high performing teams</li><li>Working knowledge of MS Office tools</li></ul><br> <br> Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/7eR6roInLmL1sZ1NF7Y5y"> <p>PI116464101</p>

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Posted: 2019-12-19 Expires: 2020-01-19

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Sr Engineer

Amgen
Thousand Oaks, CA 91360

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