Engineer I, Medical Device Design Control Documentation Specialist

Job title: Engineer I, Medical Device Design Control Documentation Specialist in Cambridge, MA at Amgen
Company: Amgen
Job description: Career Category OperationsJob DescriptionJoin 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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Engineer I - Medical Device Design Control Documentation SpecialistWhat you will doLet’s do this. Let’s change the world. In this vital role you will support device development and design control documentation. In support of Amgen’s mission to serve patients, the Device Engineering group at Amgen is a diverse team working to identify, develop, commercialize, and continuously improve drug delivery devices to optimize the patient experience.The role will be accountable to complex, multi-disciplinary and cross-functional product development efforts, managing the interactions, dependencies, and interfaces across a full device development program. The successful candidate will be a key member of the technical team that progresses towards the successful design, development, and transfer of drug delivery devices. The role ensures that the quality targets are satisfied, identifies technical risks and coordinates risk retirement activities on the program.The position is based at our Amgen Massachusetts site with the possibility of a flexible working arrangement meeting business and private needs. You will be joining Amgen device development team consisting of 50+ engineers. This position will report to the program lead.

• Provide direction and support for all technical documentation (Device Design/Testing, Design Outputs, Manufacturing equipment/process/control and Change Control records)
• Drive and be accountable for DHF documentation to ensure a clear line between platform, combination product and vendor DHF structuring
• Own risk assessment integration between requirements, risks, and mitigation implementation
• Provide oversight of the feedback loop from Design Input Requirements through Risk Assessments to the Design Outputs
• Manage and maintain the traceability between risk (Use and Functional) and Requirements
• Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control Formal Design Reviews and New Product Introduction program milestones
• Participate in project execution according to the Robust Design paradigm and principles: kinematics, tolerance design, 2D drawings, structural analysis (FEA), materials science (especially polymers) and DfM/DfA
• Utilize project planning and monitoring methods to ensure timely completion
• Review and approve completed design work

What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is an individual with these qualifications.Basic Qualifications:

• High school diploma / GED and 8 years of Engineering experience; OR
• Associate’s degree and 6 years of Engineering experience; Or
• Bachelor’s degree and 2 years of Engineering experience; Or
• Master’s degree

Preferred Qualifications:

• 5+ years of progressive experience as an engineer or scientist within the appropriate field of study
• 3+ years of experience as a Subject Manner Expert within a development or research, manufacturing environment, working with Medical Devices, ideally Class II and Class III
• Fluent in English language
• Understands documentation flow for GMP deliverables
• Solid experience in documentation authoring from project start to end, and under Design Controls
• Technical understanding of drawings
• Technical understanding of manufacturing processes (injection molding, assembly processes)
• Experience in drug/device combination product design and development
• Demonstrated experience with ISO and regulatory compliance process, Design History File
• Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues
• Experience in model-based design and UML and small-scale device assembly experience
• Experience in leading system hazard analysis, risk evaluation, and FMECA (failure mode and effect criticality analysis)
• Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position
• Familiar with : US Good Manufacturing Practices – 21CFR820; Quality Management – ISO 13485; Risk Management – ISO 14971; EU Medical Device requirements – Council Directive 93/42/EECStrong background in documenting requirements and providing traceability documentation for FDA Approval
• Practical experience in configuration management and change control process/requirements, CCB (change control board), CIT (change implementation team) concepts
• Strong interpersonal skills
• Strong communication and presentation skills
• Ability to work within cross-cultural project teams

What you can expect of 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 now and make a lasting impact with the Amgen team.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.Application deadlineAmgen 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.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 93,344.00 USD - 107,268.00 USD
Expected salary: $93344 - 107268 per year
Location: Cambridge, MA
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