25 days old

Senior Device Engineer, Final Product Technologies, Commercial Product Engineering

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115545105
Amgen

Job ID: R-87631
Location: Thousand Oaks, CA, US 91360

Job Details:

The senior device engineer will participate in the design development and lifecycle management related activities for commercialized drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, develop test procedures, scale-up and global launch, supplier development, and continuous improvement.

Scope includes mechanical and electro-mechanical delivery devices, such as; fluid transfer devices, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical and electro-mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as developing product enhancements, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.

Responsibilities:

- The senior device engineer is responsible to apply all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.

- Accountability of maintaining technical records within design history file associated with assigned products

- Develop Test Method, generate and maintain design specification, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.

- Lead system level root cause investigation, coordinate design improvements with development partners, strategic planning and execution of design changes and improvements.

- Works with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications

- Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization

The position is located in Thousand Oaks, CA and requires up to 10% domestic and international travel.

Basic Qualifications:

Doctorate Degree

OR

Master's Degree and 3 years of Engineering and/or Operations experience

OR

Bachelor's Degree and 5 years of Engineering and/or Operations experience

OR

Associate's degree and 10 years of Engineering and/or Operations experience

OR

High school diploma/GED and 12 years of Engineering and/or Operations experience

Preferred Qualifications:

Master's degree in Mechanical/Electro-mechanical or Engineering and 5+ years of related engineering experience

Medical device industry experience and regulated work environment experience

A background in developing and commercialization of medical devices and knowledge of manufacturing processes

Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion

Familiar with the following standards and regulations: Quality System Regulation - 21CFR820

Risk Management - ISO 14971, EU Medical Device requirements - Council Directive 93/42/EEC

Ability to work independently and across functional teams

Excellent (technical) written and verbal communication

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.

PI115545105

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87631<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/><b><b>Job Details:</b></b><br><br>The senior device engineer will participate in the design development and lifecycle management related activities for commercialized drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, develop test procedures, scale-up and global launch, supplier development, and continuous improvement.<br><br>Scope includes mechanical and electro-mechanical delivery devices, such as; fluid transfer devices, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical and electro-mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as developing product enhancements, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.<br><br><b><b>Responsibilities:</b></b><br><br>- The senior device engineer is responsible to apply all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.<br><br>- Accountability of maintaining technical records within design history file associated with assigned products<br><br>- Develop Test Method, generate and maintain design specification, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.<br><br>- Lead system level root cause investigation, coordinate design improvements with development partners, strategic planning and execution of design changes and improvements.<br><br>- Works with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications<br><br>- Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization<br><br>The position is located in Thousand Oaks, CA and requires up to 10% domestic and international travel.<br><br><b><b>Basic Qualifications:</b></b><br><br>Doctorate Degree<br><br>OR<br><br>Master's Degree and 3 years of Engineering and/or Operations experience<br><br>OR<br><br>Bachelor's Degree and 5 years of Engineering and/or Operations experience<br><br>OR<br><br>Associate's degree and 10 years of Engineering and/or Operations experience<br><br>OR<br><br>High school diploma/GED and 12 years of Engineering and/or Operations experience<br><br><b><b>Preferred Qualifications:</b></b><br><br>Master's degree in Mechanical/Electro-mechanical or Engineering and 5+ years of related engineering experience<br><br>Medical device industry experience and regulated work environment experience<br><br>A background in developing and commercialization of medical devices and knowledge of manufacturing processes<br><br>Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion<br><br><b><b>Familiar with the following standards and regulations: Quality System Regulation - 21CFR820</b></b><br><br><b><b>Risk Management - ISO 14971, EU Medical Device requirements - Council Directive 93/42/EEC</b></b><br><br>Ability to work independently and across functional teams<br><br>Excellent (technical) written and verbal communication<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/k5Qq8rfP8LBGH7A8i4BJg"> <p>PI115545105</p>

Categories

Posted: 2019-11-16 Expires: 2019-12-17

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Senior Device Engineer, Final Product Technologies, Commercial Product Engineering

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast