National Guard Employment Network
Device Engineer - Thousand Oaks, CA
National Guard Employment Network, Newbury Park, California, United States, 91320
Device Engineer - Thousand Oaks, CA
Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps. This role is "On-Site" at the location detailed in the job post. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Device Engineer
What you will do: 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 individual 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, using a range of program tools, design characterization and verification methods, and design reviews. The candidate ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program. Responsibilities include but are not limited to: Planning and implementing of drug delivery technical assessment tasks in support of different therapeutic areas. Develop and exploit structured, efficient approaches to analysis and design to tackle 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, implement, and report technical analyses. Develop, implement, and report verification methods and testing. Communicate effectively 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. Use 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. What we expect of you: We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications: Basic Qualifications: High school diploma / GED and 8 years of Engineering and/or Medical Device experience OR Associate's degree and 6 years of Engineering and/or Medical Device experience OR Bachelor's degree and 2 years of Engineering and/or Medical Device experience OR Master's degree 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 Ability to collaborate and converse technically with diverse partners such as hardware, software, systems, human factors, materials science, quality, reliability engineering, domain experts from commercial, clinical, molecular research, medical sciences, regulatory, drug substance and drug product development organizations Demonstrate ability to navigate ambiguity and provide a structured problem-solving approach Organizational savvy and presence to form effective relationships across functions Track record of building or participating as a member of successful teams Working knowledge of MS Office tools What you can expect of us: As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Salary Range $93,344.00 USD - $107,268.00 USD
Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps. This role is "On-Site" at the location detailed in the job post. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Device Engineer
What you will do: 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 individual 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, using a range of program tools, design characterization and verification methods, and design reviews. The candidate ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program. Responsibilities include but are not limited to: Planning and implementing of drug delivery technical assessment tasks in support of different therapeutic areas. Develop and exploit structured, efficient approaches to analysis and design to tackle 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, implement, and report technical analyses. Develop, implement, and report verification methods and testing. Communicate effectively 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. Use 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. What we expect of you: We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications: Basic Qualifications: High school diploma / GED and 8 years of Engineering and/or Medical Device experience OR Associate's degree and 6 years of Engineering and/or Medical Device experience OR Bachelor's degree and 2 years of Engineering and/or Medical Device experience OR Master's degree 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 Ability to collaborate and converse technically with diverse partners such as hardware, software, systems, human factors, materials science, quality, reliability engineering, domain experts from commercial, clinical, molecular research, medical sciences, regulatory, drug substance and drug product development organizations Demonstrate ability to navigate ambiguity and provide a structured problem-solving approach Organizational savvy and presence to form effective relationships across functions Track record of building or participating as a member of successful teams Working knowledge of MS Office tools What you can expect of us: As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Salary Range $93,344.00 USD - $107,268.00 USD