Engineer II

Let’sdo this.Let’schange the world. In this vital role you will be part of a development and sustaining device engineering team that supports final product development of Electromechanical Device Platforms. You will be responsible forensuringthe product meets all requirementsforsafety,efficacy,andfunctionality through product lifecycle management.You will managethecreationandmaintenanceofdesign documentationin accordance withquality procedures. You will be part of multi-functional teams responsible for the development of drug-device combination products.

Responsibilities:

• Providingguidanceoncombinationproductanddevicedesignrequirementsandspecifications
• Leadingproductteststrategies and executiontodemonstrateproductsafety,performance,andefficacy
• Managecombination product and device Design History Files
• Analyzingdatatosupportdesignacceptance,performancecapability,andfailureanalysis
• Creatinganddrivingtestprotocols,methods, and reports

• Transferringoftechnicalinformationtomanufacturingsitesandsupportmanufacturing scale-up and launches
• Employbasicengineeringskillsandpracticestogatheruserrequirementsandtranslate them into documentation
• Engagingsuppliersanddevelopmentpartnersregardingspecificationsandqualitylevels
• Providesauthorshipandexperttechnicalleadershipforregulatoryfilings
• Managingprojectscope,schedule,andbudget
• Ownsandsupportqualityrecords,changerecords,anddeviations
• Supports device design complaint investigations and tracking to ensuretimelyresolution and continuous improvement
• CollaboratewithProcessDevelopmentandexternalpartnersasatechnicalauthority.

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

Basic Qualifications:

• Mastersdegree
• Or
• Bachelorsdegreeand2yearsofEngineeringand/orOperationsexperience
• Or
• Associatesdegreeand6yearsofEngineeringand/orOperationsexperience
• Or
• Highschooldiploma/GEDand 8ofEngineeringand/orOperationsexperience

Preferred Qualifications:

• Bachelor'sdegreeinengineeringorotherscience-relatedfieldwith5+ yearsofrelevant work experience withdemonstratedability in operations/manufacturing environment
• Experienceinmedicaldevice,pharmaceuticalorasimilarregulatedindustry
• Backgroundindevelopmentandcommercializationofmedicaldevices,andknowledgeof manufacturing processes
• Understandingofthefollowingstandardsandregulations:
• QualitySystemRegulation 621CFR820
• QualityManagementSystemformedicaldevice/componentmanufacturers- ISO13485 Risk Management for Medical Devices 6ISO 14971
• Excellentcommunicationandtechnicalwritingskills

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.

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Salary Range