Product Center Manager, Active Medical Devices – Digital Products
Fresenius Medical Care
full-time
Posted on:
Location Type: Hybrid
Location: Bad Homburg • Germany
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Tech Stack
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
project managementmedical device regulationsquality management standardsrisk managementstatistical methodsmedical device development processessupplier quality managementdialysisdialysis water treatment
Soft Skills
interpersonal skillssolution-orientedproactivecollaborationcommunication
Certifications
Bachelor's degreeMaster's degreeISO 13485ISO 14971ICH Q10EU-GMPFDA 21 CFR §800