Senior Engineer, Design Transfer Specialist

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Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Engineer, Design Transfer Specialist

What You Will Do

Lets do this. Lets change the world. In this vital role you will participate in a technical team towards the successful design, development, and transfer of drug delivery devices. The successful candidate will be responsible for ensuring the seamless transfer of product designs from our development site to various global manufacturing sites. This role requires a deep understanding of medical device design, manufacturing processes, and regulatory requirements.

Key Responsibilities:

• Design Transfer Execution:
  Develop and execute comprehensive design transfer plans to ensure smooth transition from design to manufacturing. Designs range from single components through full assemblies. Most of the designs will be in polymers.
• Engineering Testing:
  Responsible for engineering test protocol, execution & report writing, process & test development, prototyping, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
• Documentation:
  Create and maintain detailed documentation, including design transfer plans, risk management files, and design history files.
• Collaboration:
  
  Work closely with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to ensure alignment and successful design transfer.
• Vendor Management: manage vendor relationships and ensure compliance with design specifications and regulatory requirements.
• Process Validation:
  Oversee process validation activities, including equipment and tooling qualification, to ensure manufacturing processes meet design requirements.
• Continuous Improvement:
  Identify opportunities for process improvements and implement best practices to enhance design transfer efficiency and effectiveness.

• High school diploma / GED and 10 years of Engineering experience; OR
• Associates degree and 8 years of Engineering experience;
  Or
• Bachelors degree and 4 years of Engineering experience;
  Or
• Masters degree and 2 years of Engineering experience;
  Or
• Doctorate degree

• 6-8 years of progressive experience as an engineer or scientist in relevant fields (medical device development, manufacturing, etc.)
• Proven track record of executing multiple design or tech transfers.
• 5+ years of project leadership experience in a development, research, or manufacturing environment, ideally with medical devices (Class II and Class III)
• Solid experience in medical device manufacturing and development processes, including experience working under Design Controls
• Demonstrated experience driving CTQ hierarchical decomposition (flow-down) to subsystems and components
• Proficiency in Design for Manufacturing (DfM) and Design for Assembly (DfA)
• Extensive experience in documentation authoring, especially for regulatory compliance and quality management systems
• Strong analytical skills and experience with structured problem-solving approaches
• Excellent communication and presentation skills
• Ability to work within cross-functional and cross-cultural teams
• Extensive device development competences within:
• Design of components for injection molding
• Dimensioning and tolerancing of injection molded components
• Materials science (especially polymers)
• DFM/DFA
• Strong physics/mathematics background
• CAD proficient preferably Solidworks
• Strong interpersonal skills
• 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 (21 CFR Part 4, 21 CFR 210/211, 21 CFR 820);
• Needle-based Injection Systems (ISO 11608-1);
• Quality Management (ISO 13485);
• Risk Management (ISO 14971);
• EU Medical…