Job TitleR&D ManagerThe RoleResponsible for management of people and departmental activities within the R&D/Product Development functions encompassing all activities leading to clinical and commercial approval. May lead product development projects.Reporting LinesReports to Head of R&D or designate.Key Responsibilities and DutiesThe individual will work under minimal supervision while performing the following duties: People LeadershipRecruit, manage and develop Senior and R&D engineers, providing them with clear goals and objectives and development feedback and opportunities.Seek opportunities for the building of continuous clinical and technical knowledge and expertise within the staff.Support staff in achieving project objectives.Support the development of departmental and program objectives, attached to a strategic plan, to ensure the technology reaches its potential, and the departmental resources develop to facilitate this.Manage health and safety with the test laboratory.Support the development and maintenance of departmental budgets and resourcing plans.Ensure interactions with colleagues/stakeholders fully reflects the company values:One Team: working together to ensure the whole is greater than the sum of the partsPersonal Ownership: deliver on commitmentsOpen Communication: Honest open-minded communicationFun: celebrate the successesContinuous Learning: at an individual and company levelSolution Orientated: Identify problems but focus your energy on solutionsQuality Focused: patient safety comes first TechnicalEnsure the implementation of robust engineering practices and process in the design and development of the product to ensure the final product is reliable and of the utmost quality.Ensure that test plans and testing executed aligns with regulatory requirements.Prepare regulatory submission-ready documentation for the FDA and other regulatory bodies.Support clinical activities including limited clinical case support. Perform root cause investigations of identified product failure modes. Support the ongoing development of the Companies IP portfolio.Keep abreast of technological changes within the Tricuspid Heart Valve domain, ensuring that the company and staff are up to date with the state of the art in the areas of polymer material, nitinol, tissue engineering, test methods, imaging technologies among others.Keep abreast of changing regulatory standards, and how these can impact the planned technical work within the R&D and Product Development Activities. Project ManagementMay manage the development of new products that meet patient, customer and business needs.May serve as the Project Lead on one or more project, developing plans and goals for the project which meet the overall company goals.Individually or in support role, develop project plans, timelines, budget and resource requirements and communicate these to stakeholders.Translate project plans and goals into work package ownership areas for team members and align with other management team members on individual goals and work package ownership for staff to ensure project goals are met.Strong project management skills to lead cross functional projects, ensuring on time and on budget delivery. Creative approaches to reducing project risks and shortening timelines while delivering business objectives.Provide support to team members in the execution of the work and delivery of project deliverables as the product advances through the design development cycle.Communicate with stakeholders across the company and externally to develop project/product inputs, set and manage expectations and provide updates on project progress, risks and issues.Demonstrate collaborative leadership, being able to collaborate across multiple functions, beyond R&D.Develop a positive team culture to ensure a high-performance engineering team, where the sum of the team output is greater than their individual parts.Manage external vendors/partners as necessary to support product development activities. Essential RequirementsTechnical: Strong technical capability with detailed understanding of technical principles, materials and processes used in the design and manufacture of medical devices and components. Applies extensive technical expertise to product development for areas under their responsibility. Ensures the application of strong engineering principles to ensure that the team design and develops best in class, reliable medical devices. Ensures that test plans and testing executed aligns with regulatory requirements. Prepares regulatory submission-ready documentation for the FDA and other regulatory bodies. May support clinical activities including limited clinical case support.Problem Solving: Facilitates a culture of collaborative, data-driven problem solving within the team to ensure timely resolution of technical issues with appropriate risk mitigation to ensure projects can progress as planned. Promotes best practice in relation to capture, analysis and communication of data to feed into technical decision-making across the company. Risk based problem solving to ensure highest risk items in the project are addressed.Project Management: While this is predominantly a People Leader role, the individual may take on Project Leadership roles as the need arises. Thus strong project management skills are required. The individual is capable of developing project plans, timelines, budget and resource requirements and communicating these to stakeholders. Translates project plans and goals into work package ownership areas for team members and align with other management team members on individual goals and work package ownership for staff to ensure project goals are met. Uses best-in-class tools to effectively identify, track and communicate progress and project risks across all internal and external stakeholders and ensures such risks are effectively controlled with support of other management team members. Develops creative approaches to reducing project risks and shortening timelines while delivering business objectives. Provide support to team members in the execution of the work and delivery of project deliverables as the product advances through the design development cycle. Ideally is a certified project manager, although this is not a requirement.Initiative: Manages the work of others and self under limited supervision and take initiative in communicating and alignment of project activities with stakeholders. Identify knowledge / experience gaps that exist within team and takes actions to address to ensure optimal performance. Is seen as a leader within the R&D organisation.People Skills: Has emotional intelligence and ability to build strong relationships and to positively influence collaborators / stakeholders throughout the organisation, as well as external partners. Manage and develop Senior and R&D engineers.Communication: Communicates with stakeholders across the company and externally to develop project/product inputs, set and manage expectations and provide updates on project progress, risks and issues. Proactive communication to ensure any potential significant issues are communicated upfront. Demonstrates collaborative leadership, being able to collaborate across multiple functions, beyond R&D. Develops a positive team culture to ensure a high-performance engineering team, where the sum of the team output is greater than their individual parts. Manages external vendors/partners as necessary to support product development activities.IP: Actively supports team innovation through regular contribution of disclosures to company'spatent portfolio, and maintenance of the IP portfolio. Education and ExperienceMinimum of Bachelor's degree in Mechanical or Biomedical Engineering, or related fieldMinimum of seven (7) years in a similar role in medical device product development, with a minimum of 3 years in project management/leadership role of technical projects across R&D and Manufacturing as a Senior or Principal R&D Engineer. The projects should incorporate new product development (preferably in Class III cardiovascular devices).Good leadership and project management skills with the ability and willingness to effectively build and manage a small team. Demonstrated experience in people mentoring and development.Project management skills - capable of operating and liaison at all levels including managerial, project and technical. Proven track-record in planning and resource management to meet defined project goals. Experience with processes to identify and control risks within the project. Ideally PMP or Prince 2 certified or holds similar qualification. Deep and current understanding of FDA and ISO 13485 requirements, with the ability to interpret these requirements and implement them into new product development.In depth knowledge of the EU Medical Device Regulation and MEDDEV guidance documents.Experience in design, verification, and process validation processes.Prior experience and knowledge in GMP, process validation, change control, CAPA and electronic document control systems.Broad knowledge of materials and manufacturing processes applicable to medical device industry is desirable.Experience working with sub-contract manufacturers/suppliers/test facilities, including integration of their activities into the product development activities.Previous experience of the planning and preparation of regulatory submission to agencies, competent authorities and/or Notified bodies.Experience of preparing technical documentation for design development/design control and to support submissions.Excellent communication, organisational and time management skills.Good problem-solving mindset.Strong verbal and written communication skills.At ease in start-up environment and effectiveness to deliver in low-structured environments.Demonstrated ability to communicate within a team/company structure and to achieve project and company objectives. Availability to travel is required. The above role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned from time to time.

Role Title/Job Specification: Research & Development Engineer Reporting to: Research & Development Principal Engineer or EquivalentOverview: This position requires a qualified, highly motivated, individual who will work as part of the product development start-up team through design development, verification, validation, clinical trials, regulatory approval & commercialization. The R&D Engineer will work as part of the team to design and develop a device in line with user needs, generating creative solutions to problems. Critically taking ownership on SolidWorks modelling, 3D printing & driving FEA solutions. Role and responsibilities:Perform Duties of Research & Development Engineer: Design development, 3D modelling, prototyping, test method design, design evaluation, design reviews, design specification generation, design verification and validation, design protocols and reports, transfer to production activities in a timely effective manner. Product testing and evaluation, completion of test reports to support design selection. Preparation and presentation of design reviews. Product risk analysis and risk management. Support generation of technical documentation, component specifications, assembly specifications, inspection methods, bills of materials etc.Introduction of new equipment, materials and technologies. Management of materials and vendors to support design development, concept prototype manufacture and testing methods development. Identify product and project risks and mitigations as they arise through execution of R&D work.Contribute towards process development during introduction /development of new equipment and production processes as required for any new manufacturing techniques. As required work closely with Key Opinion Leaders, physicians, product managers and team to develop innovative medical devices & provide clinically relevant feedback on product designs.To perform project tasks as delegated to him/her by the relevant manager, adhering to the company's procedures which have been developed in compliance with ISO13485, the Medical Device Directives and FDA 21 CFR 820.Communications: Regular & clear communication across team, including project status communications and reporting. Remain on the forefront of emerging industry practices. Educating oneself in the medical area for which the new devices are being developed to have an appreciation for what needs to be achieved with these products. Qualifications / Requirements: Bachelor's degree is required, preferably in mechanical engineering, biomedical engineering, or related disciplines engineering or a related field. Good working knowledge & experience of SolidWorks/FEA/3D printing required.Minimum of 2-3 years' relevant experience is desired. Good mechanical design and understanding of engineering fundamentals with medical device materials knowledge. Project planning/execution skills, execution of project in a timely effective manner. Knowledge of anatomy and physiology. Statistical understanding and experience. Manufacturing design and process understanding. Is creative, continually learning and exploring new ideas, a self-starter applies his/her own initiative in most situations.Strong technical writer. Knowledge of relevant ISO, EU, FDA medical device standards regulations is required. Willingness and availability to travel on company business.

Junior Regulatory Affairs Manager (m/w/d) || MedizinprodukteIhre Chance, die Zukunft der Medizintechnologie zu gestalten!Sind Sie ein erfahrener Regulatory Affairs Profi mit einer Leidenschaft für die Weiterentwicklung von Medizinprodukten? Möchten Sie aktiv an der Umsetzung der MDR und globaler Produktzulassungen in einem innovativen Unternehmen mitwirken? Ihre Aufgaben:MDSAP und ISO 13485-Zertifizierungen aufrechterhalten: Sie stellen sicher, dass unsere internationalen Zertifizierungen stets aktuell sind und alle regulatorischen Anforderungen erfüllt werden.Implementierung der MDR 2017/745: Sie koordinieren Projekte zur erfolgreichen Umsetzung der MDR und unterstützen die Abteilungen bei der Einhaltung der regulatorischen Vorgaben.Entwicklung von RA-Prozessen: Sie entwickeln, integrieren und überwachen RA-Prozesse und sorgen für kontinuierliche Verbesserungen.Unterstützung von Entwicklungsprojekten: Sie begleiten Entwicklungsprojekte und übernehmen die Verantwortung für die Erstellung und Pflege der technischen Dokumentation, die für die Zulassung von Medizinprodukten erforderlich ist.Audits und Inspektionen managen: Sie unterstützen nationale und internationale Audits und vertreten das Unternehmen während der Qualitätsinspektionen durch benannte Stellen.Internationale Produktzulassungen überwachen: Sie managen die Produktregistrierungen in internationalen Märkten (Europa, USA, Japan, Kanada), von der Initiierung bis zum erfolgreichen Abschluss. Ihr Profil:Abgeschlossenes Studium der MedizintechnikMind. 5 Jahre Berufserfahrung im Bereich Regulatory Affairs in der Medizintechnik.Kenntnisse der FDA und 510(k)-Prozesse sind von Vorteil, um die regulatorischen Anforderungen für den US-amerikanischen Markt sicherzustellen.Sehr gute Deutschkenntnisse in Wort und Schrift sind erforderlich, um erfolgreich mit dem internen Team und deutschen Behörden zu kommunizieren. Warum Sie sich für das Unternehmen entscheiden sollten:Karriereentwicklungsmöglichkeiten: Wir bieten Ihnen ein dynamisches Arbeitsumfeld, in dem Sie Ihre Karriere aktiv mitgestalten können, mit Möglichkeiten zur Weiterbildung und spannenden Projekten.Flexible Arbeitsmodelle: Flexible Arbeitszeiten und die Möglichkeit, remote zu arbeiten.Attraktive Vergütung und Zusatzleistungen: Ein wettbewerbsfähiges Gehalt und ein breites Spektrum an Zusatzleistungen. Bereit für den nächsten Schritt? Wenn Sie sich für die Möglichkeit begeistern, die Entwicklung von Medizinprodukten auf globaler Ebene voranzutreiben, freuen wir uns auf Ihre Bewerbung!Kontakt: Tel: 089 26 20 09 25 E-Mail: M.Inderhees@sciproglobal.de

Quality Supplier (m/w/d) im Bereich Medizintechnik Über den Kunden: Ein führendes Unternehmen im Bereich der Auftragsentwicklung- und Herstellung. Neben der GMP-Herstellung bietet das Unternehmen auch zusätzliche Dienstleistungen wie Unterstützung bei der Formulierung und Entwicklung, Optimierung der Gefriertrocknung, globale regulatorische Beratung und Sekundärverpackung. Ihre Aufgaben:Durchführung und Dokumentation von Audits hinsichtlich der Qualitätsanforderungen der Lieferanten sowie die regelmäßige Neubewertung der Lieferanten in enger Zusammenarbeit mit der QualitätsabteilungEntwicklung und Planung von Strategien und Prozessen für die Auditbewertung, Identifikation von Schwachstellen und IneffizienzenAnalyse und Bewertung der Lieferantenantworten auf Korrektur- und Präventionsmaßnahmen, die im Zusammenhang mit den Ergebnissen von Audits erforderlich sindUnterstützung bei der Überprüfung von Lieferantenanforderungen, einschließlich der Erhebung relevanter Qualitätsanforderungen und der Entwicklung von Lösungsansätzen für identifizierte Compliance-ProblemeEnge Zusammenarbeit mit den Bereichen Einkauf und Qualitätskontrolle, um die Erfüllung aller Lieferantenanforderungen zu gewährleistenFachliche Expertise bei externen Audits, internen Audits sowie behördlichen InspektionenGelegentliche Schulung und Unterstützung anderer Teammitglieder nach Bedarf Ihr Profil:Abgeschlossenes Studium im naturwissenschaftlichen Bereich sowie mehrere Jahre Berufserfahrung in den Bereichen Qualitätssicherung, Produktion oder TechnikErfahrung in den Bereichen Pharma, Medizinprodukte oder BiotechnologieErfahrung in der Durchführung von Audits in Produktionsstätten und LaborenEine Zertifizierung als Auditor (z. B. ASQ, ISO oder RAB)Sehr gute Deutsch und Englischkenntnisse in Wort und SchriftBereitschaft zu regelmäßigen Reisen, da Audits auch international durchgeführt werden Unser Angebot:Eine verantwortungsvolle und abwechslungsreiche Tätigkeit in einem qualitätsorientierten UnternehmenAttraktive Vergütung sowie flexible ArbeitszeitmodelleUmfassende Einarbeitung und kontinuierliche WeiterbildungsmöglichkeitenEin engagiertes und kollegiales Team, das sich auf Ihre Unterstützung freutZusätzliche Benefits, wie beispielsweise ein modernes Arbeitsumfeld und Mitarbeiterrabatte Interessiert? Wenn Sie sich in dieser Beschreibung wiedererkennen und eine neue Herausforderung in einem wachsenden Unternehmen suchen, freue ich mich auf Ihre Bewerbung! Bitte senden Sie Ihre vollständigen Unterlagen, an meine direkte E-Mail: M.Inderhees@sciproglobal.de