Career Category

Job Description

An exciting organizational and technical leadership opportunity to be a contributor in a high-functioning worldwide Combination Product Operation (CPO) organization. As the Amgen commercial landscape continues to exponentially grow, the Electromechanical Platforms group, as part of CPO, expands to continuously develop, enable, and manage the current and future opportunities in the field of platform delivery systems and technologies.

The Senior Device Platform Engineer will be part of the Electromechanical platforms team and support cross-functional projects. This role participates in requirements definition, design, development, and lifecycle management activities which include technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, developing test procedures, scale-up, global launch, supplier development, and continuous improvement. The qualified candidate ensures the design history files and change control of these systems are maintained.

The position is located in Thousand Oaks, CA

Job Responsibilities:

• Accountable for maintaining technical records within design history files associated with assigned products
• Responsible for Change Control Management for design improvements.
• Support system-level design, development, and V&V work for commercial lifecycle management changes or in support of new project development
• Develop test methods, generate, and maintain design specifications, 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, tactical planning, and execution of design changes and improvements
• Supports Product Delivery Teams (PDT), including creating and or reviewing quality documents, participating in Corrective And Preventive Action (CAPA) implementation, and generating or supporting ECR (Engineering Change Request) & ECO (Engineering Change Order) activities
• Works with external and internal Scientists and Engineers to assess and develop appropriate design and manufacturing specifications
• Performs as an individual contributor with leadership attributes to optimally represent device engineering within a large network/matrix organization
• Conduct work utilizing Engineering judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devise new approaches to problems encountered
• Experienced in working with external suppliers and contract manufacturing
• Ability to work independently and across functional teams.
• 10% Domestic and International travel.

Basic Qualifications

• Doctorate degree OR
• Master’s degree and 3 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment OR
• Bachelor’s degree and 5 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment OR
• Associate’s degree and 10 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment OR 
• High school diploma / GED and 12 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment experience 

Preferred Qualifications

• Electro-Mechanical, Electronics, System Engineering or equivalent engineering degree
• 5+ years of class I/Class II medical device industry experience and regulated work environment experience
• Experience with Combination Products and drug delivery devices
• Strong understanding and experience in bringing complex projects to on-time conclusion and the ability to work independently with dynamic cross-functional teams
• Knowledge of Medical Device firmware development & lifecycle management
• Strong background in the development life cycle of medical devices through definition, development, verification, commercialization, and sustaining
• Excellent written and verbal communication skills
• Superior ability to work in highly cross-functional teams, skilled at motivating people with different priorities and backgrounds to achieve a common goal
• Analytical skills to interpret data and use independent judgment and discretion in developing solutions and making decisions for a variety of moderate and complex issues
• Utilizes the following standards and regulations:
  • Quality System Regulation – 21CFR820
  • Risk Management – ISO 14971
  • EU Medical Device requirements – Council Directive 93/42/EEC
  • ISO 11608-1/ISO 11608-4/ISO 11608-5/ISO_23908
  • ISO 62304

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

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.