Senior Engineer - Device Platform Combination Product Operations

Company: Initial Therapeutics, Inc.
Location: Thousand Oaks
Posted on: May 3, 2025

Job Description:

Join Amgen's Mission of Serving PatientsAt 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. 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, 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 lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Senior Engineer - Device Platform Combination Product OperationsWhat you will doLet's do this. Let's change the world. In this role, the Senior Engineer in Combination Product Development will lead the design, development, and lifecycle management of drug delivery drug/device combination products. This includes technical operations support for design control activities, contract manufacturing, failure investigations, leading and assessing design changes, developing test procedures, leading scale-up and global launch, developing supplier capabilities, and continuous improvement.Key Responsibilities:

• Lead the multi-functional design and development teams in the final product development of prefilled syringe delivery systems, including packaging, labeling, and accessories.
• Own product life-cycle management activities, supporting final product contract manufacturing and sterilization.
• Lead product improvements, conduct analytical failure analysis, and implement design solutions.
• Author technical records and ensure they are appropriately maintained in the design history file.
• Lead system-level root cause investigations.
• Work with scientists and engineers internally and externally to develop design and manufacturing specifications, verification and validation plans, protocols, and reports.
• Author technical content in regulatory submissions.
• Represent device engineering within a large network/matrix organization.
• Evaluate test methods, prototype designs, and optimize products using DOE and statistical techniques.
• Support contract terminal sterilization processes.
• Monitor project progress, identify risks, and implement mitigation strategies to ensure project landmarks and timelines are met.
• Foster a collaborative and innovative team environment to drive continuous improvement and operational excellence.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will possess these qualifications.Basic Qualifications:Doctorate degreeORMasters degree & 2 years of Engineering and/or Operations experienceORBachelors degree & 4 years of Engineering and/or Operations experienceORAssociates degree & 8 years of Engineering and/or Operations experienceORHigh School Diploma/GED & 10 years of Engineering and/or Operations experiencePreferred Qualifications:
  • Bachelor's degree in engineering or other science-related field with 7+ years of relevant work experience with 5+ years of experience in operations/manufacturing environment.
  • Medical device industry experience and regulated work environment experience.
  • A background in developing and commercialization of medical devices and knowledge of manufacturing processes.
  • At a minimum familiar with the following standards and regulations: Quality System Regulation 21CFR820, Risk Management ISO 14971, EU Medical Device requirements Council Directive 93/42/EEC.
  • Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion.
  • Excellent communication and technical writing skills.
  • Ability to work independently and across functional teams.Preferred Skills:
    • Strong inter-personal and communication skills, with the ability to effectively collaborate with diverse teams and partners.
    • Extensive knowledge of design controls and regulatory requirements for medical devices and combination products.
    • Background in developing and commercializing medical devices and knowledge of manufacturing processes.
    • Familiarity with standards and regulations such as Quality System Regulation 21CFR820, Risk Management ISO 14971, and EU Medical Device requirements Council Directive 93/42/EEC.
    • Strong understanding and experience in design controls, failure investigation, and project management.
    • Demonstrated ability to author and review regulatory submissions.
    • Experience leading multi-functional teams and managing complex projects.
    • Demonstrated proficiency in project management.
    • Strong background in statistical analysis.
    • Strong problem-solving skills and the ability to make sound technical decisions.
    • Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities.What you can expect from usAs 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, including remote and hybrid work arrangements, where possible.Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comIn 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.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.
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Keywords: Initial Therapeutics, Inc., Costa Mesa , Senior Engineer - Device Platform Combination Product Operations, Engineering , Thousand Oaks, California