We make it GmbH is a company operating nationally in Switzerland which, thanks to many years of successful experience, has a high level of expertise in the personnel services sector. Its recruitment activities are focussed on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest demands on quality, ethics and discretion. For our client, CSL Behring based in Bern, we are looking for an   Senior Device Engineer Primary Packaging and Medical Devices (m/w/d)   Description The Primary Packaging & Medical Device (PPMD) Development organisation is focused on the design, development, commercialization and maintenance of a diverse portfolio of drug delivery technology solutions to enable delivery of CSL’s innovative therapies that improve patients' quality of life, solve unmet medical needs and save lives. The Senior Device Engineer of the Primary Packaging and Medical Devices (PPMD) Team, Bern, is responsible for the selection, evaluation, improvement, verification, implementation and maintenance of new / existing primary packaging materials & medical devices for CSL Behring products   Job Purpose This Position is aligned with the strategic growth and restructuring of PPMD (Primary Packaging and Medical Devices) Team. This position will help execute on the strategic focus area’s for PPMD, The Position is responsible for the selection, evaluation, improvement, qualification, implementation of new existing primary packaging materials, medical devices, and Combination Product for CSL Behring products, The Position will provide scientific support to maintain the design of our existing commercially released Combination Products. Coordinate cross-functionally with Regulatory, Quality Assurance, Production, Manufacturing, and Supply Chain to provide post launch support, including design and supplier-related changes, product complaints, root cause analysis and other compliance projects. The Position executes projects within the agreed time, quality and cost constraints, resulting in state-of–the-art drug delivery devices. Develop high-level plans, schedules, resource estimates, and budgets for projects under his/her responsibility. The Position will apply their knowledge of the regulatory landscape to ensure standard compliant designs, working to Quality Management Systems such as ISO 13485, and 21CFR820 Design Control, risk management to ISO14971, EU MDR requirements. The Position will establish and manage key company relationships with suppliers, CRO’s, CMO’s and standardizing Committees   Aufgaben Maintain knowledge of relevant legislation, regulation, and industry trends in the field of Medical Devices and Combination Products. Maintain own specialist expertise through exposure, education, training, and application. Assure that design verification is performed according to current scientific rational, regulatory /internal guidelines, legal requirements and quality standards. Ensuring data integrity and scientific consistency in all verification testing. Promote data analyses using advanced statistical techniques and communicate results to a cross-functional team. Application of knowledge pertaining to regulatory landscape to ensure standard compliant designs, working to Quality Management Systems such as ISO 13485, and 21CFR820 Design Control, risk management to ISO14971, EU MDR requirements, compilation (and maintenance) of Design History Files, verification and validation and clinical trial/commercial manufacture support. Present at internal and external scientific conferences to build awareness of the Groups skills and experience in the drug delivery. Contribute to the Company culture of being collaborative, respectful, transparent, ethical, efficient, high achieving, and fun! Develop and execute Human Factors Engineering plans as per current standards and guidelines (e.g. FDA HFE Guidelines, IEC 62366, EN ISO 14971, AAMI HE75, 21 CFR part 820, etc. ) Write and review HF study protocols (formative and summative studies) Supports strategic thinking for the group in the context of developing/selecting best-in-class drug delivery devices Ensure R&D efforts related to the development of new products and design modifications to existing products follow the appropriate Design Control procedures as mandated by Health Authorities Ensure robust device selection, assessment of container-device compatibility and container-drug compatibility, development of testing methods to assess container and deliver system quality and functionality for existing and new technologies. Interface with experts from outside sources, companies, and forums to maintain an understanding of new developments in drug delivery Ensuring the team assesses and utilizes the most innovative technical approaches, where feasible, for the device selection, verification and validation Executes on the business plan. Area of responsibilities include: Support of reports review of final reports, data, questions for regulatory submissions/filings Support with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions. Supporting the creation, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes. Compilation and maintenance of Design History File content and Conformity Assessments Ensuring agreed targets for quality, timelines, costs, and user requirements are met Maintains awareness of technology trends, competitive intelligence, changes in regulatory landscape Provides effective and transparent communications to team members, colleagues, and other internal and external collaborators   Qualifikation Who you are: In this role, you will collaborate with relevant stakeholders to ensure laboratory are complient with Data Integrity guidelines by implementing a Data Audit Trail Review process. With your proactive and selfresponsible approach, you take decisions and drive progress forward.The below competencies will help you to be successful in this role:   Essential Skills, Knowledge and Experience Proven ability to work closely and efficiently with employees and colleagues of all levels as well as proven ability to be independent and self-motivated, demonstrating strong organizational and communication skills. Strong scientific background in all aspects of primary packaging and drug delivery. Must have the education and experience to understand and comply with Worldwide Combination Product & Medical Device Regulations. Experience with regulatory and quality standards and generation of documentation to support quality assessments and for submission to regulatory agencies. Experience with test method development, Combination Product Verification Testing, and specification generation.   Competencies Track Record:- Highly experienced in working to Quality Management Systems such as ISO 13485, and 21CFR820 Design Control, risk management to ISO14971, EU MDR requirements, compilation (and maintenance) of Design History Files, verification and validation and clinical trial/commercial manufacture support. Knowledge of Stability Studies, Compatibility studies and long-term functionality testing Think Beyond - Maintains an external and strategic focus for self and peers. Incorporates ideas from outside CSL, and/or the industry, to improve work processes. Ignite Agility - Instills personal flexibility in self and teams. Shows openness to learning and the flexibility to adjust to new situations. Expands and builds capabilities to meet evolving business needs and helps others do the same.   Working hours Flexible work hours and options are available; however, the position is expected to have Bern on-site visibility at a minimum of 60%.     Are you interested? Then Mr. Andre Amstad looks forward to receiving your complete application documents (CV, references and training certificates) per Mail Bitte bewerben Sie sich per E-Mail an amstad@we-make-it.ch We look forward to hearing from you.