Job Description

R&D Context

The R&D activities range from platform R&D (technology and competence development) to product / formulation development R&D (customization of product technology for a specific client/market application; and transformation of platform technology from its fundamental state to commercial realization in (eventual) collaboration with client partners). The key objective for product / formulation development R&D encompasses customization of existing product technology for a specific client/market application and/or the transformation of platform technology from its fundamental state to commercial realization in (eventual) collaboration with client partners. The product / formulation R&D team operates between research (internal and external), business development and external business partners and is required to effectively integrate these different interactions in order to operate successfully. The key objective for platform R&D is proof-of-feasibility / proof-of-concept technology development driven by business needs and technology pipeline strategies. Under platform R&D also the development of new or unmet technology competences (skills and expertise development) is safeguarded.

The R&D portfolio has a strong multi-disciplinary character, i.e., comprising breadth of science & technology, application fields, and involvement of other disciplines such as Safety & Toxicology, Quality Assurance and Regulatory Affairs, Manufacturing / Operations, Sourcing, and others. Customer and market-driven R&D means providing solutions for unmet clinical needs at large, and customers' technology needs in particular. Important factors of success in Biomedical R&D comprise (i) consistently delivering the greatest level of quality with our products and services, and pursuing continuous improvement of our enabling management systems; (ii) the necessity to complement internal R&D efforts with strategically sourced external R&D and innovation; the latter particularly encompasses effective relationship building and interfacing with academic and clinical institutes, contract research organizations as well as small and large companies; and (iii) ceaselessly striving for enhancement of capabilities and competencies.

Job Content

• This role involves designing and executing experiments, analyzing results, and staying abreast of emerging trends in biomaterial research. Additionally, this role will be responsible for developing novel biomaterials, collaborating with cross-functional teams, and ensuring the successful translation of research findings into scalable, market-ready solutions. The individual should demonstrate strong problem-solving skills, a deep understanding of biomaterials, and a passion for advancing biomedical technologies.

Key Areas of Accountability / Responsibility

• Generate and process Device Master Record documentation, including process routers, drawings, preventative maintenance procedures, and other written documentation in accordance with GMP requirements to support product development, process development, validations, and manufacturing. Prepare relevant technical sections for product or regulatory submissions.
• Identify, evaluate, and implement improvements (productivity, efficiency, reliability) to existing processes or products. Assist production and quality personnel in the training, initial launch, and validation of new products and processes. Provide technical interface for internal and external stakeholders and customers.
• Plan, construct, and implement Design of Experiments (DOEs) and Risk Management Documentation as required to develop or validate new or existing products. Develop testing methods and complete Test Method Validation (TMV). Prepare protocols and reports, and provide recommendations based on completed experiments and/or tests. Develop and maintain design control systems and procedures that comply with all US/OUS medical device regulations.
• Perform analytical, mechanical, and biochemical assay testing, as well as polymer synthesis, polymer processing, natural materials manufacturing and characterization, according to Quality Systems protocols for raw materials, intermediates, and finished products while maintaining a laboratory notebook and other associated documents. Independently plans, prioritizes, and conducts research.
• Complete other tasks as assigned.

Knowledge and educational level

• Ph.D., Master's, or Bachelor's degree in analytical chemistry, chemistry or polymer science (Analytical Group).
• Skilled in polymer physical and chemical processing techniques, encompassing polymer synthesis, melt processing (extrusion, injection molding, compression molding), solution processing (film casting), foaming, machining, and sterilization. Experienced in employing analytical techniques such as DSC, TGA, TMA, Rheology, FTIR, GPC, HPLC, as well as mechanical tests including tensile, flexural, torque, torsion, and more for comprehensive polymer characterization (TPU & Polymer Processing Group); Experienced with and/or skilled in materials processing, including physical and chemical processing such as milling, mixing, lyophilization, acid/base reactions, crosslinking, thermal treatment, and sterilization. Experienced with characterization and analysis of materials using techniques such as mechanical testing, DSC, FTIR, SEM, SDS-PAGE, particle size, surface area, porosity, and more for comprehensive material characterization (Natural Material Group); Highly skilled in two or more analytical techniques. Broadly experienced in other analytical techniques. Experienced with analytical method development, validation and implementation. Demonstrated skill in analytical instrumentation trouble shooting and repair. Understanding of polymer and natural materials science (Analytical Group).
• Knowledge and experience working with Engineering & Quality tools (Statistics, Six Sigma, DFM, DOE, etc.)
• Computer literacy (i.e. Word, Excel, Project, PowerPoint, Outlook, Pro/E or similar CAD system).
• Understanding of Engineering concepts.
• Understanding of anatomy and surgical procedures.
• Good written and oral communications skills.
• Ability to function or lead as a part of a team.

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