Description

**HOW MIGHT YOU DEFY IMAGINATION?**

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

**Sr. Mechanical Engineer**

**Live**

**What you will do**

Let’s do this. Let’s change the world. In this pivotal role, you will interact with global multi-functional members from systems engineering, process engineering, device development, packaging, primary containers, device quality, and other groups.

**Responsibilities:**

+ Provide complex mechanical design support to the mechanical engineering design organization.

+ Oversee teams of junior engineers by scoping and delegating responsibilities, tracking team progress, and providing expertise and guidance

+ Technical documentation (Test Plans/Protocols/Reports, Engineering Assessments, Design outputs, test-lab equipment/process/control)

+ Prepare and provide communications to leadership in support of recommendations and assessments.

+ Verification testing strategy to include the differentiation between Platform and Combination Product testing to ensure minimum duplication and maximum efficiency when completing additional programs

+ Ensure tests methods and test protocols are developed in a sound and robust framework with a high focus on eliminating test errors

+ Implement hands-on testing of auto-injector devices, including the safe operation of test equipment

+ Collaborate with and support manufacturing sites on design/fabrication of assembly and labeling equipment

+ Conceptualize, design, and manufacture robust, accurate, and precise test fixtures to support test activities.

+ Familiarity with solid modeling (SolidWorks) and mechanical drawings using standard methodologies in accordance with ANSI/ASME Y14.5 Geometric Dimensioning and Tolerancing Standard and Y14.100 Engineering Drawing Practices

+ Contribute to and/or lead the implementation of drug delivery design projects in different therapeutic areas, including nephrology, oncology, psoriasis, RA

+ Develop, implement, and review mechanical specifications, development plans, characterization plans, and other related development documents for assigned projects

+ Assess product requirements to resolve coverage of mechanical design

+ Provide technical assistance for mechanical problems to programs as needed

+ Evaluate alternative design concepts and perform trade-off analyses

+ Perform technical analyses and develop design solutions that will meet reliability targets and reliability allocations to components

+ Tolerance and robustness analysis of complex mechanical designs

+ Create and maintain design control documents

+ Develop and implement verification plans and procedures

+ Design with emphasis on DFM/DFA; with close collaboration and guidance from the manufacturing team and other engineering groups

**Win**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients.

**Basic Qualifications:**

+ Doctorate OR

+ Master’s degree and 3 years of experience OR

+ Bachelor’s degree and 5 years of experience OR

+ Associate’s degree and 10 years of experience OR

+ High school diploma / GED and 12 years of experience

**Preferred Qualifications:**

+ Master’s Degree in Engineering, preferred Mechanical, Electrical, or BioMed

+ 6 or more years of dynamic experience as an engineer within the medical device design field

+ 3 or more years of experience in project leadership within a development or research, manufacturing environment, working with Medical Devices, ideally Class II and Class III

+ Broad set of knowledge and expertise in leading complex, multi-disciplinary and multi-functional product development efforts

+ Experience in drug/device combination product design and development

+ Background in development, commercialization, and lifecycle management of medical devices

+ Solid experience in documentation authoring from project start to end

+ Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA

+ Experience implementing lab tests, including safe and proper operation of lab equipment (Instron tensile tester, Keyence inspection equipment, etc.)

+ Experience conceptualizing, designing, and building test fixtures

+ Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering subject areas (Electrical, Mechanical, Software, etc.)

+ Experience in injection molded plastic part design, molding process, 3D solid modeling, and device assembly

+ Proficiency in FEA and SolidWorks 3D solid modeling of parts, large assemblies, and advanced surface design

+ Technical understanding of drawings, including tolerance stacks and robustness analysis

+ Proficiency with SAP PLM with SolidWorks integration for enterprise

+ Experience in leading projects from the development approval process.

+ Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions

+ Leadership ability for Characterization, Verification, and Validation testing of System and Subsystem Level Performance and Reliability characteristics

+ Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position

+ Familiar with the following standards: US Good Manufacturing Practices (21CFR820), Quality Management (ISO 13485), Risk Management (ISO 14971), EU Medical Device requirements (Council Directive 93/42/EEC), and Medical Electrical Equipment (EN 60601)

+ Strong background in documenting requirements and providing traceability documentation for FDA Approval – DOORS, Requisite Pro, or other similar requirements management software

+ Knowledge of dFMEA/pFMEA

+ Practical experience in configuration management and change control process/requirements – CCB (change control board), CIT (change implementation team) concepts

+ Demonstrated Design for Six Sigma competency

+ Strong communication and interpersonal skills

+ Strong problem solving, risk assessment, and risk management skills

+ Capable of working on different projects in a fast-paced environment

**Thrive**

**Some of the vast rewards of working here**

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

+ Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey

+ A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

+ Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

**Apply now**

**for a career that defies imagination**

Objects in your future are closer than they appear. Join us.

**careers.amgen.com**

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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