Technical product designer állások, munkák egészségügy, gyógyszeripar területen

Write, review and approve design and development documents, including design inputs, outputs, verification, validation, and design transfer activities...

• Provide guidance on regulatory and quality requirements, including MDR and FDA requirements, for our in-house and our customer software projects
• Create technical documentation for our industry projects together with our software development teams

• Working with high throughput lab – analyzer
• Routine lab work with infectious samples and leading of own experiments including the analysis of them
• Plan and execute different work packages for the development of molecular diagnostics test

• Become an expert in Brainlab's orthopedic planning and endovascular navigation portfolio
• Demonstrate solutions both in person and online, showcasing clinical value through interactive demos, workshops, and webinars

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

• Lead strategic relationships with CMOs to improve cost, quality, delivery performance and innovation (annual spend $60-70M)
• Conduct regular business reviews (SRM) and monitor KPIs, performance metrics, and contractual compliance

• Maintain and further develop our QMS in line with EN ISO 13485 and MDSAP
• Create, update, and improve procedures, forms, and training materials
• Plan and deliver training on procedures and regulatory requirements
• Lead and oversee CAPA initiation, processing, tracking, and review

Govern and steer the innovation pipeline, ensuring effective project management of all innovation initiatives in line with stage gate principles...

• Create, edit, manage and modify all product and process documentation using PLM and ERP software packages.
• Be a part of the Manufacturing team with extensive interactions with the R&D and Quality departments.

• Support of our subsidiaries, distributors, clinics and patients worldwide
• Technical support for and comprehensive knowledge of the middle ear implant (VIBRANT SOUNDBRIDGE and PMEIs) and the bone conduction solutions (BONEBRIDGE and ADHEAR)

Select and qualify packaging suppliers to ensure high-quality materials. Collaborate with suppliers to choose optimal packaging for Fresenius Kabi´s products....

You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements...

• PhD in biochemistry, protein chemistry, or a related biological science
• Strong hands-on experience in peptide and protein chemistry, including solid-phase peptide synthesis and chemoselective ligation techniques

You will be a focal point for our customers, on how to best align their transformational business & IT initiatives with our SAP portfolio, partner solutions and the latest product developments, for achieving the best outcomes and value for their day-to-day operations....

Unterstützung innerhalb der F&E-Abteilung/Einführung neuer Produkte (Neuproduktentwicklung und Innovation) und anderer geschäftskritischer und/oder umsatzfördernder Maßnahmen von der Planung bis zur Kommerzialisierung...

• New business acquisition
• Renewals of expiring contracts or new tender issued by existing customers as well price negotiations ensuring customers having the right prices
• Establish value propositions and build business cases
• Post‐sale involvement with customers

Development of product strategies for existing and new portfolios, including market research to identify innovation opportunities in lens technology and design, as well as defining product specifications and managing the product lifecycle...

Deliver technical expertise in the development of container closure systems, including vials, prefilled syringes, and prefilled cartridges, by employing cutting-edge methodologies to conduct comprehensive analyses and evaluations of their protection, safety, compatibility, and performance attributes...

• Perform optical simulations of devices for eye care using optical simulations in Ansys/Zemax (Optic Studio)
• Interact with a modern (object oriented) python framework to automate simulations as well as investigations and visualizations

Cross-Disciplinary Roadmap Definition: Define and drive a comprehensive robotics roadmap that serves various clinical disciplines, ensuring long-term strategic alignment....