Sr. Engineer Combination Product Inhalation Device Lead

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity and obesity-related conditions. 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.

Sr. Engineer - Combination Product Inhalation Device Lead

Lets do this. Lets change the this vital role you will join the Combination Product Development and Transformation (CPD&T) team to lead systems engineering and device development activities for dry powder inhaler (DPI) combination support of Amgens mission to serve patients the CPD&T team develops drug-device combination products to support Amgens portfolio of drugs and biologics for patient-centric drug delivery. The Sr. Engineer will provide technical leadership across combination-product design controls translating user and patient needs and product objectives into robust system and device requirements interface definitions design outputs verification strategies and integrated drug-device-capsule solutions.

The Sr. Engineer will own and drive key Design History File (DHF) and Design and Development Plan (DDP) activities for the DPI device constituent including needs and requirements engineering system and subsystem interface definition design reviews design verification strategy configuration management and change control. The role will apply EDDO / delivery-output thinking to identify and control the device outputs most important to dose delivery aerosolization usability and overall combination-product performance and will maintain clear traceability from needs and requirements through risk controls design outputs verification and supporting evidence.

The Sr. Engineer will also lead technical integration of supplier-provided DPI platforms and evidence. This includes assessing the applicability of supplier design verification manufacturing and master-file (MAF) evidence; identifying gaps and appropriate bridging needs; and providing technical oversight of device suppliers. The role will partner closely with other combination product SMEs as well as drug product analytical and methods regulatory quality manufacturing clinical human factors and other development teams to integrate DPI device design and airflow characteristics aerosolization fundamentals capsule-device interactions and drug-device-capsule performance into the product development strategy.

The Sr. Engineer will also:

Lead combination-product systems engineering and device development for DPI programs including system architecture needs and requirements engineering interface definition technical trade-offs integration planning and design reviews.

Own or lead DHF/DDP deliverables for the DPI device constituent and ensure design-control documentation is complete coherent configuration-controlled and aligned with the evolving combination-product design.

Establish and maintain end-to-end traceability among user and product needs system and device requirements EDDO / delivery outputs risk controls design outputs verification activities and objective evidence.

Develop the design verification strategy for the DPI device and integrated combination product including rationale for use of supplier evidence platform knowledge bridging analysis and product-specific testing.

Apply DPI platform knowledge and inhalation fundamentals including device resistance airflow aerosolization and powder-dispersion behavior in partnership with analytical and methods teams to support device selection development and performance understanding.

Lead drug-device-capsule integration defining and managing critical interfaces among the dry-powder drug product capsule inhaler and user to achieve reliable dose delivery and aerosol performance.

Assess supplier technical evidence and MAF applicability identify evidence gaps and bridging needs and provide technical oversight of device suppliers including design changes investigations verification evidence and lifecycle support.

Coordinate with regulatory quality drug product analytical manufacturing clinical human factors suppliers and other cross-functional stakeholders to support technical decisions submissions issue resolution and lifecycle changes.

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:

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

Preferred Qualifications:

Direct experience developing capsule-based or other dry powder inhaler platforms and combination products from early development through design verification and regulatory submission.

Experience with aerosol performance characterization and methods such as delivered dose uniformity aerodynamic particle size distribution device resistance/pressure-flow characterization or related inhalation testing.

Experience assessing supplier design-history verification manufacturing and master-file evidence including applicability/bridging decisions and letters of authorization where applicable.

Experience supporting FDA or global regulatory submissions for drug-device combination products including technical responses design-control evidence and device constituent documentation.

Experience providing technical oversight of external device suppliers and leading cross-functional resolution of device performance integration manufacturing or lifecycle issues.

Knowledge of fluid dynamics aerosol science particle dispersion/deagglomeration or modeling approaches relevant to DPI device performance.

Experience with platform-device strategies configuration/change control and risk-based bridging of device evidence across products or presentations.

• Experience providing technical mentoring or serving as a subject matter expert in combination-product systems engineering device development or inhalation delivery systems

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.

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.

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 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.

Salary Range