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Sr. Engineer Digital Product Lead (Design Controls) in Cambridge, Massachusetts


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.


What you will do

Let’s do this! Let’s change the world!

The Sr. Engineer Digital Product Lead will be a Business Analyst, Digital Product Lead and Change Agent for the digitalization of the design controls and manufacturing business processes for combination products at Amgen. You will be part of the Digital & Data Strategy department within Amgen’s Combination Product Operations (CPO) and own the deployment of Product Lifecycle Management (PLM) tools that will help digitize combination product design control and manufacturing workflows. The CPO Digital team is one of a network of Amgen digital teams focused on implementing innovative digital capabilities transforming the business by improving efficiency and speed, while reducing the cost, of developing, manufacturing, and distributing combination products to our stakeholders and patients.

The Digital Product Lead will work within a cross-functional organization to shape the product vision, lead the build effort, and deliver change successfully for CPO by ensuring full adoption of all PLM capabilities that support product development, design controls, and manufacturing for device platforms and secondary packaging. The successful candidate will work with user groups within CPO to refine relevant business processes for digitalization and work with the PLM Platform and Product teams in a Scaled Agile Framework (SAFe) to build, enhance and update key capabilities supporting the digital workflows. Additionally, the candidate will provide user support and feedback for system updates and enhancements and support the business in onboarding and training users in digitalized workflows and new capabilities.


  • Will be the CPO Functional Area Lead & Change Agent for Design Controls within PLM

  • Drives strategy and helps define priorities for the digitalization of combination product design controls (build digital thread).

  • Interfaces regularly with CPO customers for stakeholder analysis and business process mapping

  • Defines business process requirements for PLM platform

  • Define and implement adoption plan for impacted teams within CPO (change agent)

  • Translate business needs and work with IS during product implementation

  • Lead project Agile team scrums, govern the platform, and present status to management

  • Translate business needs and implementation strategies between IS development team and business partners

  • Leads triage of requested user experience and workflow/data model enhancements

  • Verify proper implementation of business needs throughout the implementation and qualification of the product.

  • Lead testing workshops with target user groups to assess new features during implementation and qualification of the product.

  • Responsible for customer delight: usability and utility of the final digital thread

  • Raises issues/requests to management, participates in creative solutions to project issues

  • Interface with business process owners for the update of business processes.

  • Ensures appropriate training is available and delivered to customers and team members


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 employee with these qualifications.

Basic Qualifications:

Doctorate degree


Master’s degree and 3 years of engineering experience


Bachelor’s degree and 5 years of engineering experience


Associate’s degree and 10 years of engineering experience


High school diploma / GED and 12 years of engineering experience

Preferred Qualifications:

  • M.S. Degree in Mechanical/ Chemical/ Biomedical Engineering with business analysis and design controls experience

  • Experience in a product development function: Systems engineering/ Risk engineering/ Design Engineering, within a design control environment

  • Excellent understanding of device development business processes & design control workflows

  • Strong communication and cross-functional collaboration skills: ability to distill, craft and present key messages relative to diverse audience requirements

  • Demonstrated ability to work in a highly matrixed team environment.

  • Strong hands-on experience with Dassault Systemes’ 3DEXPERIENCE PLM platform or similar PLM software

  • Demonstrated capability to lead cross-functional teams with 2-3 years in a project lead role

  • Understanding of Enterprise digital strategy and awareness of connectivity across relevant platforms such as PLM, Electronic Lab Notebook (ELN), Laboratory information management system (LIMS), etc.

  • Solid understanding of Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate manner

  • Demonstrated capability to influence and motivate change with impacted stakeholders

  • Strong problem solving, trouble shooting, and communication skills

  • Experience with Agile Software development processes is a plus


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

Amgen focuses on areas of high unmet medical need and uses 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.

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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.