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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Senior Engineer-Sustaining Engineering

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will perform Sustaining Engineering activities of combination products with electromechanical delivery systems. Such activities support the identification, review, assessment, and resolution of deficiencies throughout the product’s life cycle. Responsible for product life cycle change management and ensures design controls are documented in accordance with internal procedures.

Office-based role supporting virtual teams via Webex and phone.

Flexibility required when working with global colleagues in various time zones.

Must be able to travel up to 20%.

Key Responsibilities

• Complete product and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and product design integrity is maintained
• Implement change projects according to internal procedures, supervise progress, and communicate status to group leadership
• Liaison between Engineering, Production sites, Regulatory, and Quality colleagues
• Establish experimental protocols, conduct experiments, analyze results
• Support technical execution of Design History File (DHF) updates
• Contribute to Annual Product Review activities
• Establish and maintain relationships with production site colleagues
• Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material/processes changes
• Establish and review specifications/requirements for components, products and processes
• Support CAPA investigations
• Ensures product conforms to current relevant international standards
• Support multi-functional assessment of complaint record

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The technical professional we seek is a collaborative partner with these qualifications.

Basic Qualifications

• Doctorate degree OR
• Master’s degree & 3 years of directly related engineering experience OR
• Bachelor’s degree & 5 years of directly related engineering experience OR
• Associate’s degree & 10 years of directly related engineering experience OR
• High school diploma / GED & 12 years of directly related engineering experience

Preferred Qualifications

• Bachelor's degree in Engineering, Science or other technical degree
• 1-3 years of experience with Medical Device or Combination Products Design Controls, Production, Sustaining Engineering, or Quality role
• Proven knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products
• Experience analyzing patient/user impact
• Understanding and practical knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and related standards
• Critical thinking, and problem-solving skills
• An ability to work independently as well as a member of a team in a fast-paced environment
• Working knowledge of statistical methods for data analysis
• Familiar with microcontroller-based firmware, software verification (unit, static, dynamic analysis)
• Familiar with circuit design, analysis, troubleshooting, and testing, PCB/PCA assembly and fabrication
• Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering fields
• The position requires excellent organizational, technical problem solving and communication skills (written and verbal) and the ability to lead external teams

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 maximize 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.

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