Senior Device Engineer

Career Category

Job Description

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 illnessesdrives 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 Device Engineer

What you will do

Lets do this! Lets change the world!

The Senior Device Engineer serves as a technical leader in the design development and lifecycle management of drug delivery devices (e.g. prefilled syringes vial kits) used in Amgens combination products. This role provides advanced engineering expertise leads complex investigations drives crossfunctional alignment and influences decisions impacting Amgens strategic product portfolio. This role is accountable for ensuring that associated design history files for devices are robust compliant and strategically positioned for long-term sustainability. This role also seeks to enhance capabilities of the prefilled syringe and kit platform evaluates and implements design changes as necessary develops and strengthens technical standards contributes to global product strategy and launches and will act as a technical mentor to peers and junior engineers while representing the device engineering function across the broader Amgen network.

Essential Skills and Responsibilities

• Functions as a fully competent and highly independent subject-matter expert applying advanced engineering judgment to evaluate adapt and create methodologies that solve complex technical challenges.

• Leads design and development efforts influencing technical direction and ensuring alignment with prefilled syringe and vial kit platform strategy as well as regulatory expectations.

• Hosts and facilitates design reviews and assessments both during development as well as post-launch for commercialized devices.

• Serves as a technical reviewer and approver for design documentation analyses and verification/validation packages.

• Directs system-level root cause investigations with cross-functional stakeholders ensuring robust technical justification and durable corrective actions.

• Uses statistical tools modeling and risk-based frameworks to diagnose issues and develop data-driven solutions.

• Oversees creation and maintenance of design specifications technical standards protocols test methods and comprehensive engineering reports.

• Leads design verification and validation workstreams FMEA leadership and statistical process control efforts where applicable.

• Ensures technical records meet global regulatory expectations and withstand inspection scrutiny.

• Acts as a key technical representative within networked project teams exercising influence across functions such as Product Quality Regulatory Process Development Supply Chain and external partners.

• Drives design improvements with development partners contract manufacturers and suppliers by integrating feedback capability assessments and manufacturability strategies.

• Contributes to long-term technology roadmaps and platform expansion efforts.

• Leads design changes post-launch investigations product optimizations and scale-up activities.

• Supports and defends regulatory submissions inspections and commitments at a senior level.

• Serves as a technical mentor and coach to other core and extended team members.

• Demonstrates advanced working proficiency in 21 CFR 820 Quality System Regulation ISO 14971 Risk Management and design control processes.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Engineering and/or Operations experience OR

• Associates degree and 8 years of Engineering and/or Operations experience OR

• Bachelors degree and 4 years of Engineering and/or Operations experience OR

• Masters degree and 2 years of Engineering and/or Operations experience OR

• Doctorate degree

Preferred Qualifications:

• Degree in Mechanical Biomedical or related Engineering discipline.

• Extensive experience in medical device/combination product development commercialization and regulated manufacturing environments.

• Experience with products with ophthalmic indications.

• Experience with lifecycle management of commercialized medical devices or combination products.

• Proven ability to lead complex cross-functional engineering programs from concept through launch.

• Deep expertise in design controls applied statistics reliability engineering and advanced problem-solving methodologies.

• Strong verbal and written communication skills with the ability to tailor messaging at multiple organizational levels.

• Excellent communication and technical writing skill.

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 well 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. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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 diverse 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.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.

Salary Range