Amgen Senior Manager Device Engineering in Cambridge, Massachusetts

Amgen is seeking a Senior Manager in our Device Engineering group. This position will report to our Director of Systems Engineering. In support of Amgen's mission to serve patients, the Device Engineering group at Amgen is a diverse team working to identify, develop, commercialize and continuously improve drug delivery devices in order to optimize the patient experience.

The Senior Manager will lead complex, multi-disciplinary and cross-functional product development efforts, managing the interactions, dependencies and interfaces across a set of subsystems. The successful candidate will lead technical teams towards the successful design, development, transfer, and lifecycle management of drug delivery devices. This role will interface with customers and vendors to facilitate the proper design analyses and ensure customer satisfaction.

Responsibilities:

Lead technical project teams including direct supervision of employees and contingent workers

Managing risk, resources, cost, and schedule for the technical deliverables

Discover and understand end-user requirements (patient, caregiver, etc.) and translate user needs into system requirements

Develop system requirements for compliance to standards

Evaluate alternative system design concepts and perform trade-off analyses

Establish system performance & reliability targets and allocations to components

Develop and execute system verification and validation plans & procedures

Provide technical leadership for regulatory filings

Provide direction and support for the optimal design of complex, large scale systems through consideration of the system as a whole, rather than individual components of the system.

Provide technical coaching and mentoring to more junior engineers

Up to 25% domestic/international travel

Basic Qualifications:

Doctorate degree and 2 years of Engineering experience

OR

Master's degree and 6 years of Engineering experience

OR

Bachelor's degree and 8 years of Engineering experience

OR

Associate's degree and 10 years of Engineering experience

OR

High School diploma / GED and 12 years of Engineering experience

Preferred Qualifications:

Master's Degree or PhD in Engineering, preferred Mechanical, Electrical, or BioMed

10+ years of progressive experience as an engineer or scientist within the appropriate field of study

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

Experience in leading projects from development approval process. - Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions

Experience in drug/device combination product design and development

Strong problem solving, risk assessment, and risk management skills

Capable of working on multiple projects in a deadline driven environment

Strong background in developing, commercialization, and lifecycle management of medical devices

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

Demonstrated applied Six Sigma competency, including DFSS

Creative problem-solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues

Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program

INCOSE certification or formal Systems Engineering training/certification

Demonstrated experience driving CTQ hierarchical decomposition (flow-down) to subsystems and components

Demonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product

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

Experience in system design and architecture that ensure product development success and ensuring Accurate Development Cycles between teams

Leadership ability for System Level Design and Testing (Verification and Validation testing of System Level Performance)

Experience in resolving system engineering issues such as device hardware/firmware or device/programmer system architecture design tradeoffs, tolerance/performance analysis, etc.

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: (1) US Good Manufacturing Practices (21 CFR Part 4, 21 CFR 210/211, 21 CFR 820); (2) Needle-based Injection Systems (ISO 11608-1); (3) Quality Management (ISO 13485); (4) Risk Management (ISO 14971); (5) EU Medical Device requirements (Council Directive 93/42/EEC); (6) 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

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

Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives

Strong interpersonal skills

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

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.