[15h Left] Ism Engineer

Career Category Safety Join Amgen s Mission of Serving Patients At 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 Group Purpose Post Market Surveillance Trending group is responsible for conducting science-driven evaluations to assess the safety and quality of Amgen s combination products medical devices companion diagnostics and digital health products The group is responsible for post market surveillance product complaints trending and data analytics Additionally the group analyses the potential impact of quality issues on patient user safety across these products Job Summary The ISM Engineer is responsible for performing product complaints statistical excursion trending deep dives Prepares product complaints and or adverse events data to support ad-hoc analysis and regulatory inquiries as well as generate process metrics to support process surveillance activities Key Activities Performs product complaints statistical excursion trending deep dives Understand customer patient use of Amgen s packaged and or distributed mechanical and or electromechanical products Understand manufacturing processes for Amgen s packaged and or distributed products Maintain close interaction with multiple functions including Quality e g complaints device quality product quality external supplier quality manufacturing quality quality engineering and contribute to product device design improvements Collaborate with other safety functions to support integrated surveillance of Amgen products from both quality and safety s perspectives Prepares and interprets adverse events and product complaints data supporting integrated product surveillance activities Prepares product and process surveillance metrics for internal safety and quality governance forums Pulls complaints and or adverse events data to support ad-hoc analysis and regulatory inquiries Perform data verification of complaints data pulled for inspection requests Applies analytical skills to evaluate complex situations using multiple sources of information Contribute to technology innovation initiatives related to post market surveillance including AI ML and automation opportunities Contribute to improvements in trending methodologies and process improvement opportunities Support audits and inspections as appropriate Knowledge and Skills Required Knowledge and Skills Quality and or manufacturing experience in biotech or pharmaceutical industry Complaints or complaints trending within a development manufacturing or post-market environment Knowledge of product complaints and adverse events intake and processing process Ability to pull and create product complaints and or adverse events data per request Knowledge of medical devices or combination products ideally Class II and Class III Data querying skills and experience with data visualizations tools such as Tableau Power BI or Python Preferred Knowledge and Skills Proven experience with mechanical and or electromechanical medical devices Knowledge of combination products and medical devices including device safety monitoring regulations and standards Ability to perform data analysis and derive insights Education Experience Preferred Degree in Engineering or Life Science 5-9 years of quality and or manufacturing experience as an engineer in the biotech or pharmaceutical industry 2 years of experience in complaints or complaints trending within a development manufacturing or post-market environment working with medical devices or combination products ideally Class II and Class III Experience with statistical trending methodology preferably complaints Strong data analysis experience and a passion for finding correlations across different datasets Experience with data querying and business intelligence tools Strong presentation and teamwork skills 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 well-being From our competitive benefits to our collaborative culture we ll support your journey every step of the way In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards Apply now for a career that defies imagination Objects in your future are closer than they appear Join us careers amgen com 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 with 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