Integrated Signal Management (ISM) Engineer

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