Senior Systems Engineer

Amgen; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Amgen in the United States is seeking a Senior Systems Engineer to lead development activities within a cross-functional program team for a device/biologic combination product, delivering system content, performance, and quality deliverables. You will translate user needs into system requirements, manage risk and verification, and maintain traceability and design documentation.

Regular collaboration with engineering, quality, regulatory, supply chain, and manufacturing ensures lifecycle changes

Qualifications

• Doctorate degree
• Master's degree + 2+ years of experience
• Bachelor's degree + 4+ years of experience
• Associate's degree + 8 years of experience
• High school diploma or GED + 10 years of experience
• 6+ years of progressive experience as an engineer

Responsibilities

• Lead development activities for a cross-functional program team to create technical content, performance, IP and quality deliverables for a combination product.
• Own systems engineering deliverables, ensure quality targets, identify risks and coordinate risk retirement activities.
• Maintain close cross-functional interaction across engineering, quality, regulatory, supply chain, packaging, labeling and product teams to manage lifecycle changes in a controlled manner.
• Lead requirements development and maintenance, including user needs, design inputs/outputs, and verification/validation planning.
• Mentor junior engineers and contribute to design reviews and issue resolution.

Job description

Career Category

Engineering

Job Description

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you'll 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, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Systems Engineer

What you will do

Let's do this! Let's change the world! The Senior Systems Engineer leads development activities within a cross-functional program team to create the technical content, performance, intellectual property and quality deliverables of a combination product (device/biologic combination) development program.

• This role leads the capture of user needs and translation into system requirements and is also responsible for the functional decomposition and allocation to subsystems.
• The Senior Systems Engineer owns respective systems engineering deliverables and ensures that the quality targets are satisfied, identifies and communicates technical risks and coordinates risk retirement activities on the program.
• Also, maintains close cross-functional interaction within Amgen to deliver on customer satisfaction through high product quality.
• This AMA-based role requires regular collaboration during East Coast business hours and partners across engineering, quality, regulatory, supply chain, packaging, labeling, and product teams to ensure lifecycle changes are assessed, documented, and implemented in a controlled manner.
• Lead systems engineering assessment, planning, and cross-functional coordination of lifecycle change controls.
• Perform system-level impact assessments for proposed changes, including impacts to requirements, design documentation, risk management, traceability, verification evidence, and combination product configurations.
• Maintain system requirements, specifications, and traceability as released systems evolve.
• Determine and coordinate re-verification or additional verification when lifecycle changes could affect the verified state.
• Maintain systems engineering-owned design control documentation, including requirements, traceability, verification plans and reports, risk inputs, and change assessments.
• Support supplier-, packaging-, labeling-, manufacturing-, and subsystem-driven changes that affect the combination product system.
• Lead systems engineering evaluation and implementation planning for new or revised standards and regulatory requirements.
• Support design transfer activities and implementation of approved lifecycle changes.
• Drive continuous improvement in lifecycle management processes, requirements practices, verification approaches, and reuse of engineering evidence.
• Communicate technical assessments, recommendations, risks, and implementation status to cross-functional stakeholders and leadership.
• Lead requirements development and maintenance activities, including alignment of user needs, design inputs, design outputs, and verification and validation planning.
• Review and approve completed design documentation.
• Drive systems engineering input to design reviews and facilitate cross-functional resolution of system-level technical issues.
• Mentor Junior engineers.

What we expect of you

Basic Qualifications:

• Doctorate degree
• OR
• Master's degree and 2 years of experience
• OR
• Bachelor's degree and 4 years of experience
• OR
• Associate's degree and 8 years of experience
• OR
• High school diploma / GED and 10 years of experience

Preferred Qualifications:

• 6+ years of progressive experience as an engineer within the appropriate field of study.
• 5+ years of experience in product development working with mechanical medical devices, ideally combination products (device/biologics combination).
• Formal Systems Engineering training/certification.
• Demonstrated applied lean 6 Sigma competency.
• Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.
• Demonstrated experience in systems engineering, product development, medical devices, or combination products.
• Strong lifecycle management and change-control experience in a regulated environment.
• Strong