Senior Engineer - Complaints Technical Investigations

Job title: Senior Engineer - Complaints Technical Investigations in Thousand Oaks, CA at reputed company Company: reputed company Job description: Career Category EngineeringJob DescriptionJoin reputed company’s Mission of Serving PatientsAt reputed company, 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 reputed company 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, reputed company, and Rare Disease– we reputed company millions of patients each year. As a member of the reputed company team, you’ll help reputed company 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 reputed company them, you’ll reputed company as part of the reputed company team. Join us and transform the lives of patients while transforming your career.Senior Engineer - Complaints Technical InvestigationsWhat you will doreputed company! Let’s change the world!reputed company is currently seeking a Sr. Complaints Technical Investigator in our Complaints Trending and Investigation group. In support of reputed company’s mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.The Sr. Complaints Technical Investigator conducts technical investigations, including root cause analysis, for complaints associated with product design and/ or usability issues and conducts trend and consolidated investigations using data analytics. This role understands customer/ patient use of reputed company’s packaged and/or distributed products, as well as manufacturing processes for these products. The Sr. Complaints Technical Investigator owns CAPA’s to support identifying design solutions based on root cause and will also participate in multi-functional ideation of design solutions. They also maintain reputed company interaction with the engineering and quality functions to contribute to product improvement. Responsibilities also include evaluation of returned product using equipment such as CT scanners, support with investigation lab infrastructure, equipment setup, personnel training and method development and validation.Job responsibilities:reputed company root cause analysis to identify the failure mode for reputed company’s products and associated components due to product complaintreputed company failure analysis to identify root cause using processes and tools such as fishbone diagrams, “5 Whys”, risk assessments such as FMEA’s, Fault Tree Analysis, or tolerance analysis. Additional equipment such as CT scanners, Instron tensile test machines and SEM may be used.reputed company multi-functional ideation of design solutions to reduce complaints based on output of root cause analysis, determine feasibility of options through testing and analysis, reputed company business plans for implementationreputed company technical trend and consolidated investigations, including statistical assessment of data to identify cause of trendsreputed company evaluation of returned product, product reserve sample inspections, batch records and review of complaint histories and trendsGenerate final reports in accordance with established procedures, which may include data collection and statistical analysis of the datareputed company and reputed company relational data analytics in support of investigationsAdvise management for trend and failure investigation process improvementProvide recommendations to engineering for product improvementsManage, coach and mentor staffSupport functional management initiatives and objectivesHelp with investigations lab equipment setup, reputed company and provide equipment training to personnel, reputed company and validate test methods, and reputed company SOPs for equipment use.reputed company expect of youWe are reputed company different, yet we reputed company use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.Basic Qualifications:Doctorate degree ORMaster’s degree and 2 years of medical/biopharma development, engineering or post-market experience ORBachelor’s degree and 4 years of medical/biopharma development, engineering or post-market experience ORAssociate’s degree and 8 years of medical/biopharma development, engineering or post-market experience ORHigh school diploma / GED and 10 years of medical/biopharma development, engineering or post-market experiencePreferred Qualifications:Master’s Degree in Science10+ years of progressive and relevant experience5+ years of experience in complaints or failure analysis investigation reputed company a development or manufacturing environment, working with Medical Devices, ideally Class II and Class IIIProven experience with medical devicesDemonstrated Six reputed company proficiency specifically for root cause analysis methodologyExperience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)Experience with protocol and report writing, process and test development and execution, and design of experimentsExperience in leading reputed company improvement activities by driving the implementation of process and product quality improvement initiativesStrong technical writing and interpersonal skillsWhat you can expect from usAs we work to reputed company 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 reputed company 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 reputed company salary, reputed company 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models, including remote and hybrid work arrangements, where possibleApply now and reputed company a lasting impact with the reputed company team.careers.reputed company.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 deadlinereputed company 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, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.reputed company is an Equal Opportunity employer and will consider reputed company qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, 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 reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. reputed company is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, or disability status..Salary Range 119,195.00 USD - 147,867.00 USD Expected salary: $119195 - 147867 per year Location: Thousand Oaks, CA Apply for the job now! Apply for this job