Senior Systems Engineer

Amgen; Cambridge (MA); On-site; USD 115,000 - 156,000; Full time

Benefits offered by this job

Total Rewards Plan

Retirement Plan

Medical coverage

Dental & Vision

Disability Insurance

Flexible Spending Accounts

Stock-based incentives

Bonus program

Paid time off

Flexible work model

Job summary

Amgen is seeking a Senior Systems Engineer to lead cross-functional development for a combination product program. You will translate user needs into system requirements, maintain traceability, and drive risk assessment and verification activities across engineering, quality, regulatory, supply chain, packaging, labeling, and product teams.

You will ensure lifecycle changes are documented and implemented, while mentoring junior engineers.

Qualifications

• Doctorate or Master’s degree with 2+ years of experience, or Bachelor’s with 4+ years.
• Preferred: formal Systems Engineering training/certification.
• Experience in medical devices or combination products.

Responsibilities

• Lead cross-functional systems engineering activities for a combination product program.
• Create system requirements, architecture, and verification plans.
• Manage lifecycle changes and design controls across functions.
• Coordinate risk management and verification evidence.
• Mentor junior engineers and support design transfer.
• Communicate assessments and recommendations to leadership.

Skills

Cross-functional leadership

Systems engineering

Requirements management

Traceability

Risk assessment

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

None

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

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

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 understanding of design controls, requirements management, traceability, risk management, and design verification.
• Experience conducting technically rigorous system-level impact assessments and defining verification needs for product changes.
• Ability to lead assessment of new and revised standards and regulatory requirements and translate them into actionable engineering plans.
• Proven cross-functional coordination and influence skills across technical, quality, regulatory, and operational functions.
• Excellent written and verbal communication skills, including the ability to clearly document technical rationale and present complex information to diverse stakeholders.
• Experience translating stakeholder and user needs into clear, testable system requirements and maintaining end-to-end traceability.
• Working knowledge of system integration, interface management, design reviews, and verification and validation planning.
• Ability to lead technical discussions, evaluate tradeoffs, and resolve cross-functional system-level issues.

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Equal Opportunity Employer

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Salary Range

115,494.60USD -156,257.40 USD

About Amgen

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 biologics manufacturing 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. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen