Kristian Ullum

Experience

• 

  Novo Nordisk

  Jan 2016 - Jan 2017

  Student Assistant - Device R&D - Design, User Experience & Prototype

  Student Assistant in Device R&D department focusing on user experiences and prototypes.My main responsibilities in this position has been:• Maintaining 3D printers (SLA, SLS and FDM printers) • CAD work (PTC CREO)• Preparing daily print jobs • Cleaning SLA and SLS prints • Coordinating prototyping with inhouse designers and engineers

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  Grotesk ApS

  Sept 2018 - Dec 2020

  Co-founder and Product Designer

  Grotesk was a research and design lab where I was responsible for developing innovative and circular acoustic solutions for the building industry. My primary responsibilities in this position have been:• Execution of Life Cycle Assessments for bio-based construction materials• R&D testing and verification, including laboratory work• Prototyping, designing, and modelling of acoustic mycelium panels• Conducting quantitative and qualitative user research• Validating acoustical panel designs with architects • Facilitate co-creation workshops with craftsmen• Testing material properties in collaboration with the Danish Technological Institute• Writing funding applications for various projects, with a track record of securing funding from public and private entities.• Managing grant-funded projects from start to finish, ensuring that all deliverables are completed on time and within budget, and communicating regularly with funders to provide updates on project progress.Achievements: • Nominated for Design Award "Green Product of the Year" by Bolig Magasinet and Costume Living.• The receiver of "Energiforum Danmarks Innovationspris" for the project" From Waste to Biomaterials" in collaboration with Søren Jensen A/S• Part of winner team in the 'Circular Construction Challenge' by Realdania and the Danish Design Center.• Designer and exhibitor at C40 World Mayors Summit at BLOX in Copenhagen. • Designer and exhibitor at the Carpenters Autumn exhibition 'Re-think, Re-use, Re-duce' at DAC in Copenhagen. Vis mindre

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  Natus Medical Incorporated

  Aug 2021 - Jan 2023

  Process Development Consultant, R&D

  At Natus Medical, I have been a part of medical devices post-market changes, NPI, and remediation projects. I have filled the role of a technical project manager, taking responsibility for mechanical and manufacturing process design and validation activities. My primary responsibilities in this position have been:• Leading design and process validation activities for medical device class II, in accordance with ISO13485 and Design Control principles • Updating and maintaining mechanical design documentation (PTC CREO) to ensure up-to-date record and seamless communication between the design and manufacturing teams• Collaborating with cross-functional teams to define and execute process validation plans, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing processes and test methods • Designing and developing protocols and reports for process validation activities, including PFMEA, work instructions, and packaging and handling test plans • Working closely with contract manufacturers globally to ensure that process validation activities are carried out per requirements and proposing corrective actions as needed • Creating and maintaining Design History Files (DHF) and Device Master Records (DMR) • Contributing to the development and updating of manufacturing procedures, process flows, and quality standards to ensure compliance with regulatory requirements • Managing Engineering, Document, and Manufacturer Change Orders (ECO, DCO, MCO) related to process development activities • Creating packaging designs and leading the development of Packaging and Handling Tests• Ensuring that all biocompatibility, REACH, and RoHS documentation is up to date • Working closely with Quality and Operations teams to investigate and resolve any line-down situations and proposing and executing corrective actions in a timely manner• Supporting update of labelling and IFUs Vis mindre

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  Novo Nordisk

  Jan 2023 - Jan 2023

  Process Validation Consultant, Packaging Department

  At Novo Nordisk, I have been an integral member of the process validation team in the packaging department. As part of the expansion program, our focus was on standardizing process validation activities and associated documentation. In this role, my primary responsibilities have included:• Assisting in the preparation and review of process validation documentation such as URS, PFMEA, FAT/SAT, IV (Installation Verification), OV (Operational Verification), and PQ (Performance Qualification).• Engaging closely with cross-functional teams to ensure alignment between validation and operational processes.• Upholding the highest standards in accordance with industry regulations and Novo Nordisk's rigorous quality standards Vis mindre

• 

  UNEEG medical A/S

  Jan 2023 - Jan 2023

  Compliance Engineering Consultant, R&D

  As a Compliance Engineer, I have played a crucial role in ensuring compliance with European directives and industry standards for three low-voltage medical testing Jigs developed for UNEEG by ProInvent. My primary responsibilities included:• Conducting research to identify relevant EU directives for medical device test equipment, enabling CE marking and compliance with industry standards.• Performing thorough risk assessments for low voltage equipment and implementing design measures to minimise potential safety risks.• Coordinating safety- and EMC tests at third-party testing facilities to ensure compliance with the 2014/53/EU Radio Equipment Directive, 2014/30/EU EMC Directive, and 2014/35/EU Low Voltage Directive. Vis mindre

• 

  Natus Medical Incorporated

  Jan 2023 - now

  At Natus Medical, I have played a key role as the Process Development Lead in both NPI and Sustaining project teams. My primary responsibilities have included:• Collaborating with design teams to develop manufacturing strategies for medical devices, including electronic assemblies and high-end optical designs.• Acting as the primary technical liaison between Natus and contract manufacturers.• Ensuring appropriate traceability between system, subsystem, process verification and validation, and cross-functional deliverables.• Developing and sourcing building prototypes.• Establishing and completing pFMEA. • Creating the Design Transfer Plan and the Product Quality Manufacturing Plan.• Creating and reviewing Equipment Specifications.• Working with contract manufacturers to develop and improve manufacturing processes.• Execute and/or oversee Process Validation activities • Identify, implement, and advocate engineering best-practices within product development teams, including contributing to improving quality system proceduresIn this role, I have contributed to the successful transfer of designs to production, ensuring high quality and compliance with industry standards. Vis mindre

  • Senior Process Development Engineer, R&D

    Jun 2024 - now

  • Process Development Engineer, R&D

    Jan 2023 - Jun 2024