Senior Engineer I, Product Development

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As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.
The Senior Engineer, Product Development, reports to the Head of Department R&D, and is responsible for contributing to R&D projects across the full development lifecycle. This includes the translation of market requirements into technical specifications, design development, introduction of new technologies, design verification and coordination of design transfers encompassing process optimizations, product validation and product approval.
The Senior Engineer, Product Development, works closely with the respective Project Managers and participates in R&D projects spanning multiple BIOTRONIK sites, requiring international cross-site collaboration. He/she executes policies, processes, and methods, and generates documentation in accordance with established standards to maintain consistency across sites.
The Senior Engineer, Product Development, establishes and maintains effective communication with global project team members and stakeholders across operations, quality, manufacturing, management and other departments.
The Senior Engineer, Product Development, will also lead sub-projects, act as stream owner, drive research initiatives, and support the Product Maintenance role with product and design expertise.
Your Responsibilities
Oversees daily operations and tasks of the R&D Product Development Group and supports the Head of Department R&D
Leads internal sub-product development projects in support of System Projects
Takes responsibility as Sub-Project Manager Hardware Development within Product Development Projects
Develops products and qualifies and integrates new technologies and materials, leveraging extensive technical knowledge and product specifications, in compliance with external standards, internal rules, design rules, and internal requirements (e.g. marketing, production, economic, and quality requirements), in accordance with the project plan
Ensures quality in product design with respect to usability, reliability, functionality, marketability, and manufacturability
Supports product development through product design criteria, product function and customer needs, complaint assessments, animal studies, and supplier interactions
Assesses the feasibility of new product specifications and defines specific product requirements in the product specification
Supports product design verification and validation, taking design and production processes into consideration
Develops new test methods to address new product requirements; analyzes data using statistical techniques and communicates results to cross-functional teams
Analyzes and evaluates product complaints
Conducts risk assessments of the product and its components; participates in risk assessments of related production processes
Provides technical expertise and support to operations, manufacturing, and product maintenance
Trains production personnel on new and existing methods
Prepares structured reports by collecting, analyzing, and summarizing information and trends
Analyzes statistical data and product specifications to determine standards and establish quality and reliability objectives for finished products, in collaboration with manufacturing and quality departments
Ensures adherence to standard operating procedures, company policies, and applicable regulations
Maintains safe work practices and a safe work environment
Your Profile
Bachelor’s Degree in Electrical, Mechanical or Industrial Engineering or equivalent.
Minimum 5 years of experience in R&D, product development, or process/production engineering, preferably in the Medical Device Industry
Proven expertise in medical product development and regulatory approval processes in an international environment
Experience with manufacturing processes, automation, and related methods
Experience working in a quality- and design-controlled environment, with familiarity with ISO13485 and GMP requirements
Knowledge of verification and validation principles for medical devices
Proficiency in project management, with the ability to lead and coordinate cross-functional activities
Strong aptitude for hands-on

Employment type
Unlimited