Hybrid Product Center Manager, Active Medical Devices – Digital Products

at Fresenius Medical Care

• Job title: Product Center Manager, Active Medical Devices – Digital Products
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: TypeScript
• Location requirements: Hybrid, Bad Homburg, Germany

About the role

• Product Center Manager for medical devices optimizing product lifecycle across global markets in Germany. Ensuring project compliance and fostering continuous improvement in regulatory processes.

Responsibilities

• Ensure proper project execution and manage the product lifecycle across all global markets
• Establish efficient and effective interfaces with Business Units and other internal stakeholders (e.g., Manufacturing, Supply Chain, Systems/Quality/Regulatory) to enable rapid global market access and meet business requirements
• Oversee capacity management and prioritize Product Center activities in alignment with the strategic priorities of the respective Business Unit
• Identify, quantify, and communicate quality-related project risks in product development and lifecycle management
• Ensure external regulatory information from the medical device market and authorities is understood and incorporated into Fresenius processes and products
• Foster a culture of continuous improvement and process optimization and share best practices across global departments and Care Enablement
• Develop, implement, and monitor performance using relevant Key Performance Indicators (KPIs)
• Monitor, analyze, report, and derive appropriate actions regarding product quality for the entire in-center Business Unit product portfolio, including active medical devices, medical device systems (ecosystems), and relevant trade goods
• Collaborate with relevant stakeholders to support creation and maintenance of a harmonized document management structure for regulatory documents across all product groups based on a global system
• Act as representative in cross-functional teams as well as in governance and project review meetings
• Support risk assessments for serious product risks identified during post-market surveillance

Requirements

• Bachelor's or Master's degree in Engineering or a comparable technical discipline, e.g., Biomedical Engineering, Medical Informatics, or a natural science
• Solid knowledge of medical device regulations (NMPA, MDD 93/42/EEC, MDR 745/2017, MDSAP, FDA, etc.)
• Good knowledge of relevant quality and risk management standards (e.g., ISO 13485, ISO 14971, ICH Q10, EU-GMP, FDA 21 CFR §800, etc.)
• Strong project management skills
• Excellent interpersonal skills with a focus on working proactively and solution-oriented in interdisciplinary teams
• Knowledge of medical device development processes, supplier quality management, trade goods, and production transfers is advantageous
• Basic knowledge of statistical methods
• Knowledge of medical devices and their clinical application
• Good knowledge of the application area of medical products, preferably dialysis, including dialysis water treatment
• Fluent German and business-fluent English

Benefits

• Individual opportunities for self-directed career planning and professional development
• A corporate culture that allows room for innovative thinking – to collaboratively find the best, not the fastest, solution
• Many committed people with diverse skills, talents, and experiences
• The advantages of a successful global company with the collegial culture of a medium-sized business