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System Manager Entwicklung Medizingeräte (m/w/d) - Job Opportunity at Löwenstein Medical SE & Co. KG

Hamburg, Germany
Full-time
Senior
Posted: January 26, 2025
Hybrid
EUR 75,000 - 95,000 annually based on Hamburg market rates for senior medical device development roles

Benefits

Comprehensive pension plan with company contribution indicating strong long-term investment in employees
Subsidized Deutschland ticket showing commitment to sustainable commuting
Flexible working hours with hybrid options demonstrating modern work culture
30 days vacation exceeding German market standard
Corporate benefits package including JobRad program
Cafeteria subsidy and fresh fruit provision showing focus on employee wellbeing
Continuous professional development opportunities

Key Responsibilities

Lead system testing and verification processes for medical devices, ensuring regulatory compliance and product quality
Spearhead implementation and optimization of device systems and subsystems
Drive feasibility studies and troubleshooting initiatives
Develop and enhance commissioning and verification concepts
Define and document subsystem requirements
Collaborate on subsystem development projects
Manage technical communication with external stakeholders for certification projects

Requirements

Education

Master's or Diploma degree in Medical Technology, Mechatronics, or Electrical Engineering

Experience

Previous experience in medical device development and verification required

Required Skills

High self-motivation and self-organization Analytical and conceptual thinking Problem-solving competence Strong communication skills Goal orientation Resilience Quality and responsibility consciousness Learning motivation Excellent German language skills Good English language skills Experience with regulatory requirements Experience with FDA approvals (preferred)
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Sauge AI Market Intelligence

Industry Trends

The medical device industry is experiencing rapid growth in smart respiratory care solutions, with increasing focus on remote monitoring capabilities and data integration Regulatory requirements are becoming more stringent globally, particularly with the EU MDR implementation creating higher demand for regulatory expertise Growing emphasis on software integration and connectivity in medical devices is driving need for cross-functional expertise

Role Significance

Typically leads or coordinates with 5-8 team members across engineering and quality functions
Senior technical position with significant influence on product development and regulatory compliance

Key Projects

Medical device certification projects including FDA and EU MDR compliance System architecture development and optimization Cross-functional verification and validation programs Technical documentation and regulatory submission preparation

Success Factors

Deep understanding of medical device regulatory landscape Ability to bridge technical and quality management requirements Strong project management capabilities with focus on regulatory timelines Excellence in stakeholder communication across technical and business functions

Market Demand

High demand due to expanding medical device sector and increasing regulatory complexity

Important Skills

Critical Skills

Regulatory expertise in medical devices due to complex compliance requirements System engineering capabilities for medical device architecture Quality management system knowledge for maintaining compliance Technical communication skills for stakeholder management

Beneficial Skills

Experience with connected health technologies Knowledge of respiratory medicine Understanding of international markets Project management methodologies

Unique Aspects

Combination of established German engineering tradition with modern medical technology
Focus on respiratory medicine providing specialized expertise development
Strong emphasis on 'Made in Germany' quality standards while maintaining global market presence

Career Growth

2-4 years in role typically required before advancement to director-level positions

Potential Next Roles

Technical Director Head of Regulatory Affairs R&D Director Senior Program Manager

Company Overview

Löwenstein Medical SE & Co. KG

Mid-sized medical technology company specializing in respiratory diagnostics and therapy, operating under the larger Löwenstein Group umbrella

Strong position in German medical device market with growing international presence
Significant presence in Hamburg's medical technology sector with global market reach
Traditional German engineering culture with modern flexible work practices and strong focus on quality and innovation
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