Development Engineer (m/f/d)
Department:
Research & Development / Engineering
Reports to:
Head of Development
Location
: Deggendorf, Germany
The Development Engineer is responsible for the development, optimization, and industrialization of medical device components and assemblies, with a focus on check valves, tubing sets, and injection molded plastic parts. The role covers the full product lifecycle, from customer requirements and concept development to series production, ensuring technical feasibility, regulatory compliance, and economic efficiency.
Responsibilities and Duties
Product & Component Development
* Development of medical device components and assemblies, with a focus on:
*Check valves
*Tubing sets and fluid path systems
*Injection molded plastic components and assemblies
* Design, dimensioning, and optimization of plastic and multi-component parts
* Selection of suitable materials (e.g. thermoplastics, elastomers) considering biocompatibility, sterilization methods, and media compatibility
* Creation of CAD models, technical drawings, and bills of materials
Project Work & Industrialization
* Technical responsibility for development projects from concept to series release
* Planning and execution of development activities in line with timeline, cost, and quality targets
* Close collaboration with production, quality, purchasing, and suppliers
* Support of tool design, injection molding trials, sampling, and production ramp-up
* Participation in design reviews, risk analyses (e.g. Design FMEA), and validation activities
Customer Support & Technical Interface
* Technical support of customer projects in cooperation with sales and project management
* Analysis and implementation of customer-specific requirements
* Technical coordination with customers regarding design, functionality, and feasibility
* Support in technical clarifications, complaints, and product changes
Quality & Documentation
* Creation and maintenance of development-related documentation (e.g. specifications,
* reports, test plans)
* Support of design control processes according to ISO 13485 and MDR
* Participation in verification and validation activities
* Support during internal and external audits from an engineering perspective
Responsibilities & Authority
* Technical ownership of assigned products, components, or development projects
* Contribution to decisions on design concepts, materials, and manufacturing processes
* Responsibility for achieving development targets related to time, cost, and quality
* Technical point of contact for internal departments and customers
Qualification Profile
Professional Requirements:
* Degree in Mechanical Engineering, Plastics Engineering, Medical Engineering, or comparable
* qualification
* Several years of experience in the development of medical devices or components
* Solid knowledge in:
*Plastics engineering and injection molding
*Development of valves or fluidic systems
*Tubing and connection systems
* Experience with CAD systems (e.g. SolidWorks, Creo, Inventor)
* Knowledge of regulatory requirements (ISO 13485, MDR) is an advantage
* Fluent in English; German language skills are an advantage
Personal Competencies:
* Structured, independent, and solution-oriented working style
* Strong technical understanding combined with a pragmatic mindset
* Confident communication with customers and internal stakeholders
* Team-oriented with a high sense of responsibility
* Motivation to continuously improve products and processes
Quality & Regulatory Requirements
* Compliance with design control requirements according to ISO 13485
* Participation in risk management activities (e.g. Design FMEA)
* Ensuring traceability of requirements, design decisions, and changes
* Support of CAPA and change control processes
* Contribution to maintaining a compliant and audit-ready development environment
Key Performance Indicators (KPIs)
KPI Target / Measurement
Project milestone adherence ≥ 90 % on time
Design changes after release ≤ 2 per project
Fulfilment of customer requirements 100%
Complaints with development root cause < 3 per year
Time-to-market Reduction by 5% p.a.
Documentation completeness 100 % compliant
Development Opportunities
* Progression to Head of Development
* Career path towards Product Line ownership
* Participation in innovation and new product development initiatives