17 days old

Development Engineer

Amgen
Cambridge, MA 02138
  • Job Code
    119119316
Amgen

Job ID: R-96048
Location: Cambridge, MA, US 02139

In support of Amgen's mission to serve patients, the Development Product Engineering Organization at Amgen is a diverse team responsible for identification, development, commercialization, and continuous improvement of drug delivery technologies to optimize the patient experience for Amgen's portfolio of therapeutic products.

The Development Engineer works as part of a multi-disciplinary program team to build drug delivery solutions which meet user requirements for Amgen's portfolio of therapeutic products from concept through commercial entry. The Development Engineer advances technical programs, contributing to definition of design requirements, identification and realization of technical solutions, authoring of test methods and reports, and authoring of technical analyses to advance programs. The successful candidate establishes well-supported insights for concept and development stage solutions to serve user needs and the needs of the pipeline portfolio, demonstrating a range of program tools, design characterization and verification methods, and design reviews. S/he ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program.

Responsibilities:

Planning and execution of drug delivery technical assessment tasks in support of different therapeutic areas, including nephrology, bone health, oncology, inflammation, and cardiovascular.

Develop and exploit structured, efficient approaches to analysis and design to solve complex engineering problems.

Support investment analysis for drug delivery technologies through demonstration that proposed solutions meet user needs in service of Amgen's product pipeline.

Develop, execute, and report technical analyses.

Develop, execute, and report verification methods and testing.

Communicate optimally at multiple organizational levels on project status, risks, issues, and accomplishments.

Successfully influence program outcomes.

Review completed design work with both internal and external design partners.

Utilize project planning and monitoring methods to ensure accurate completion.

Ensure compliance to Regulatory and Quality requirements when generating design outputs and conducting technical reviews.

Contribute to and use advanced computer simulations to support design & development efforts.

Collaborate with the commercial engineering organization to ensure adequate sustainment and improvement of products throughout their lifecycle.

Facilitate development of solutions to critical business issues.

Effectively define objectives to enable effective metrics generation and reporting.

As part of the team working on device platforms, ensure alignment to architecture to support variations of the platform and system deliverable packages.

Basic Qualifications

Master's degree

Or

Bachelor's degree and 2 years of Engineering and/or Medical Device experience

Or

Associate degree and 6 years of Engineering and/or Medical Device experience

Or

High school diploma / GED and 8 years of Engineering and/or Medical Device experience

Preferred Qualifications
  • 2+ years industry experience in development of drug delivery technologies for therapeutic products through commercial entry
  • Working knowledge and familiarity with the following:
  • US Quality System Regulations for Medical Devices (21CFR820) and International Quality Management Systems for Medical Devices (ISO 13485).
  • Drug-Device and Biologic-Device Combination Product Requirements for cGMP.
  • Physical test method development, qualification, and validation, ISO 14971 and ISO 11608.
  • Laboratory equipment and techniques for drug delivery device development and testing. Managing laboratory assets and test samples.
  • CAD and 3D printing of test fixtures and prototypes.
  • Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
  • Strong problem-solving skills
  • Capability to advance multiple projects in a fast paced environment
  • Strong oral and written communication skills, decision making, presentation, and organization skills
  • Proven ability to collaborate and converse technically with diverse partners such as hardware, software, systems, human factors, materials science, quality, reliability engineering, domain specialists from commercial, clinical, molecular research, medical sciences, regulatory, drug substance and drug product development organizations
  • Proven ability to navigate 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 an efficient team
  • Working knowledge of MS Office tools


We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

PI119119316

<b>Amgen</b><br/><br/><b>Job ID: </b>R-96048<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/>In support of Amgen's mission to serve patients, the Development Product Engineering Organization at Amgen is a diverse team responsible for identification, development, commercialization, and continuous improvement of drug delivery technologies to optimize the patient experience for Amgen's portfolio of therapeutic products.<br><br>The Development Engineer works as part of a multi-disciplinary program team to build drug delivery solutions which meet user requirements for Amgen's portfolio of therapeutic products from concept through commercial entry. The Development Engineer advances technical programs, contributing to definition of design requirements, identification and realization of technical solutions, authoring of test methods and reports, and authoring of technical analyses to advance programs. The successful candidate establishes well-supported insights for concept and development stage solutions to serve user needs and the needs of the pipeline portfolio, demonstrating a range of program tools, design characterization and verification methods, and design reviews. S/he ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program.<br><br><b>Responsibilities:</b><br><br>Planning and execution of drug delivery technical assessment tasks in support of different therapeutic areas, including nephrology, bone health, oncology, inflammation, and cardiovascular.<br><br>Develop and exploit structured, efficient approaches to analysis and design to solve complex engineering problems.<br><br>Support investment analysis for drug delivery technologies through demonstration that proposed solutions meet user needs in service of Amgen's product pipeline.<br><br>Develop, execute, and report technical analyses.<br><br>Develop, execute, and report verification methods and testing.<br><br>Communicate optimally at multiple organizational levels on project status, risks, issues, and accomplishments.<br><br>Successfully influence program outcomes.<br><br>Review completed design work with both internal and external design partners.<br><br>Utilize project planning and monitoring methods to ensure accurate completion.<br><br>Ensure compliance to Regulatory and Quality requirements when generating design outputs and conducting technical reviews.<br><br>Contribute to and use advanced computer simulations to support design & development efforts.<br><br>Collaborate with the commercial engineering organization to ensure adequate sustainment and improvement of products throughout their lifecycle.<br><br>Facilitate development of solutions to critical business issues.<br><br>Effectively define objectives to enable effective metrics generation and reporting.<br><br>As part of the team working on device platforms, ensure alignment to architecture to support variations of the platform and system deliverable packages.<br><br><b>Basic Qualifications</b><br><br>Master's degree<br><br><b>Or</b><br><br>Bachelor's degree and 2 years of Engineering and/or Medical Device experience<br><br><b>Or</b><br><br>Associate degree and 6 years of Engineering and/or Medical Device experience<br><br><b>Or</b><br><br>High school diploma / GED and 8 years of Engineering and/or Medical Device experience<br><br><b>Preferred Qualifications</b><br><ul><li>2+ years industry experience in development of drug delivery technologies for therapeutic products through commercial entry</li><li>Working knowledge and familiarity with the following:</li><li>US Quality System Regulations for Medical Devices (21CFR820) and International Quality Management Systems for Medical Devices (ISO 13485).</li><li>Drug-Device and Biologic-Device Combination Product Requirements for cGMP.</li><li>Physical test method development, qualification, and validation, ISO 14971 and ISO 11608.</li><li>Laboratory equipment and techniques for drug delivery device development and testing. Managing laboratory assets and test samples.</li><li>CAD and 3D printing of test fixtures and prototypes.</li><li>Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations</li><li>Strong problem-solving skills</li><li>Capability to advance multiple projects in a fast paced environment</li><li>Strong oral and written communication skills, decision making, presentation, and organization skills</li><li>Proven ability to collaborate and converse technically with diverse partners such as hardware, software, systems, human factors, materials science, quality, reliability engineering, domain specialists from commercial, clinical, molecular research, medical sciences, regulatory, drug substance and drug product development organizations</li><li>Proven ability to navigate 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 an efficient team</li><li>Working knowledge of MS Office tools</li></ul><br><br>We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.<br><br>Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.<br><br>Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.<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/X7lgpDu2o8WqIlR4ueYQ8"> <p>PI119119316</p>

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Posted: 2020-03-18 Expires: 2020-04-18

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Development Engineer

Amgen
Cambridge, MA 02138

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