Senior Engineer - Combination Product Operations, Risk Engineering (CPO-RE)

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 awardwinning 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 Engineer Combination Product Operations Risk Engineering (CPORE)

What you will do

Lets do this! Lets change the world!

Amgen is currently seeking a Senior Engineer in our Combination Product Operations Risk Engineering (CPORE) team for Risk Management. In support of Amgens mission to serve patients the CPORE team at Amgen is a diverse team working to develop and continuously improve our drug delivery devices and combination products to ensure supply and to optimize the patient experience.

The Sr Engineer will be responsible for development and lifecycle management of the Risk Management Files (RMFs) for Amgens portfolio of products serve as Risk Management lead on assigned projects and support Design Control processes and activities.

The Sr Engineer will create/maintain risk assessments such as System Risk Assessments and Use Risk Assessments with close coordination with respective multifunctional teams.

The Sr Engineer will bring to bear leadership skills to actively engage with multifunctional groups to support the Risk Management File as well as support multifunctional processes collaborating with Risk Management. This includes working with the Complaints Safety Human Factors and other teams to support life cycle management.

The Sr Engineer will support regulatory medical device reporting requirements for agencies such as FDA and European Competent Authorities including representing CPORE in corresponding audits. The Sr. Engineer will assist with the advancement of design controls activities/processes the continued advancement of risk assessment processes methods and tools and business processes for ongoing continuous improvement.

Responsibilities include but are not limited to:

• Ensures Risk Management Files are in alignment with 21CFR Part 820 design control and risk management requirements of ISO 14971.

• Creates and maintains the Risk Management Files.

• Conducts risk assessments and creates/revises risk management documents as required by Standard Operating Procedures FDA EU and other medical device and combination product regulations.

• Creates and maintains hazard analyses use risk assessments and system risk assessments for combination products with manual mechanical or electromechanical device constituent parts.

• Contribute to process improvement efforts for Risk Management and Design Controls.

• Actively collaborates with design engineers to drive design mitigations and establish effectiveness of the risk control measures.

• Leads periodic and event driven risk reviews of the Risk Management Files for commercialized products.

• Supports the complaints intake teams with assessment of risks related to reported complaints.

• Supports the medical safety teams with assessment and responses to regulatory agencies and competent authorities related to medical device reporting requirements

• Successfully influences outcomes communicates with all levels of the organization facilitate development of solutions to critical business issues and effectively define objectives to enable effective metrics generation and reporting.

• Understands manufacturing processes for Amgens packaged and/or distributed products.

• Supports root cause analysis of complaint investigations.

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:

• Bachelors or Masters Degree in Engineering preferred Mechanical Engineering Electrical Engineering Systems Engineering Materials Engineering or BioMedical Engineering.

• 6 or more years of experience with risk analysis methods such as PrHA and FMEA for medical devices.

• 5 or more years of experience in a Medical Device Development or Device Risk Management role.

• 3 or more years of experience with Medical Device Reporting requirements preferably for the European Union.

• Extensive experience with risk management per ISO 14971 (2019).

• Experience with Design Controls 21 CFR 820 (820.30 Design Controls).

• Experience in leadership role(s) and working with multifunctional groups.

• Experience working with complaints intake and complaints investigation teams.

• Ability to read analyze and interpret general business periodicals professional journals technical procedures or governmental regulations.

• Ability to converse (oral and written) technically with mechanical electronic software and quality engineers.

• Capable of managing multiple projects in a deadline driven environment.

• Strong technical writing and interpersonal skills.

• Working knowledge of MS Office tools including artificial intelligence

• Working knowledge of digital PLM platform tools

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 wellbeing. 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 salesbased incentive plan

• Stockbased longterm incentives

• Awardwinning timeoff plans

• Flexible work models including remote and hybrid work arrangements where possible

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

In any materials you submit you may redact or remove ageidentifying 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.

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.

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