R&D Engineer in the acute disposables product family, responsible for lifecycle management, design control, technical specifications, product changes, supplier changes, and global product audits.
Responsibilities
Develop and manufacture innovative dialyzers and dialysis catheters
Act as technical expert for lifecycle management of acute R&D disposables
Create, review, and approve design control documents
Prepare design control documentation
Develop, maintain, and update technical specifications
Requirements
Hochschulabschluss in Chemie, Verfahrenstechnik, Maschinenbau, Medizintechnik or comparable
To lead, co-ordinate, supervise and undertake Design and Development projects in the Product Development department of AliveDx (Alba). Record, analyse and reach valid conclusions for complex investigations.
Responsibilities
Assist in planning, organising and undertaking work to Product Development studies and projects with support from the Principal Scientist, Department Leader and the project managers.
Record and analyse the results of experimental work from specific Development projects as assigned by the Principal Scientist and/or Department Leader to meet Design Control requirements in project files and the departmental objectives.
Assist with the supervision and training of other staff within or out with the team to ensure continuous development of staff capabilities.
Monitor the safe operation, control and maintenance of equipment in accordance with established procedures to minimize delays to work programmes and ensure a safe working environment.
Conduct all duties in compliance with local procedures, Good Documentation Practice (GDP) and appropriate regulatory requirements and report any observed breaches to the Department Leader and Technical Compliance Group if applicable.
Support Quality Engineering senior staff in new product development for hardware/software medical device products.
Responsibilities
Support new product development and implementation of new hardware/software products via risk management file development
Support new product development by participating on cross-functional core team and providing quality input to product user needs, design inputs, software requirements, detailed design specifications and design outputs
Support design verification testing, design validation and usability testing, including protocol and use case development, test execution and report writing
Develop and release engineering design documentation, support core team during design reviews and support design history file compilation/audit activities
Support manufacturing quality activities including measurement systems analysis, incoming inspection, control plans, process summaries and process FMEA
Requirements
B.S. in engineering or a technically related field
Quality Engineer responsible for building and shipping units, ensuring quality across hardware and software, automating processes, and managing supplier and equipment quality.
Responsibilities
Support the build day to day ensuring parts, equipment, and records are ready
Own supplier and incoming quality, including qualifying suppliers and inspections
Own equipment and calibration program end to end
Write and run verification protocols and support design control
The minimum annual base salary for this position is 38.400Euro. Your starting salary may be higher, depending on factors such as your skills, experience, qualifications, and the unique perspective you would bring to the role.
Responsibilities
Be member of Project Core teams for New Product Development Projects and design Change Controls as Product Quality representative.
Executes Product Quality activities within New Product Development (NPD), Sustaining Engineering (SPO) and Regulatory Compliance projects for dialysis electromechanical devices, based on the project assignments received by the Product Quality Manager.
Review the documents for Device History File issuing and maintenance.
Assure compliance to all applicable corporate procedures as well as all local work instructions and applicable laws and standards.
Ensures that complaint data and CAPA corrective actions from current products are considered in sustaining engineering activities.
Requirements
Degree in Engineering (Biomedical field preferred) or scientific disciplines
The Supplier Quality Engineer is responsible to support the selection, qualification, and management of suppliers, ensuring product/service quality meets Insulet requirements, while also managing Design Control initiatives.
Responsibilities
Maintain approved supplier list and supplier history records in accordance with quality system requirements.
Assist with the qualification of new suppliers, new components, and changes.
Maintain accuracy of Supplier Audit Reports and Supplier Profile.
Develop and maintain the Supplier Audit Schedule.
Plan and conduct scheduled audits of suppliers to assess compliance with Insulet Requirements.
End-to-end technical oversight of manufacturing technologies spanning suppliers, contract manufactures, automation houses, and internal manufacturing, including technical support for on-market production.
Compensation
$111,100.00 - $185,100.00
Responsibilities
Lead and support new product process development, design of experiments and measurement system analyses to collect and analyze applicable data relative to program process development targets.
Execute design control activities with emphasis on design transfer and understanding of system design and the linkage between technical and business requirements, design and process failure modes and process controls.
Review design changes and optimize manufacturing processes for new and existing medical devices, focusing on scalability, efficiency, and quality improvements.
Utilize statistical tools and methods to analyze process data, conduct capability studies, and implement process controls.
Develop and execute test methods with necessary protocols and reports to validate process performance and product quality.
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