Combination Product Device Development Engineerjob

vor 3 Monaten

Bern, Schweiz Consultys Vollzeit

Missions 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) 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 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

Profil At least 5 years’ experience in Pharma Device Development University degree, in a relevant field of science e.g. engineering, in biotechnology / biochemistry / biology or corresponding qualification based on work experience in a relevant field. 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. 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. 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 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.
- Flexible work hours and options are available; however, the position is expected to have Bern on-site visibility at a minimum of 60%.

  • Principal Scientist in Plasma Product Development

    vor 6 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    Within Plasma Product Development, we develop novel, high quality plasma-derived therapies that improve the health and well-being of our patients around the world. Our ability to innovate and deliver life-saving medicines for these individuals living with rare diseases and other unmet medical needs has earned us a reputation for always putting patients...

  • Head of Human Factors

    vor 2 Monaten

    Bern, Schweiz Hays Vollzeit

    Job Responsibilities:Lead and manage a department of Medical Affairs specialists and a Human Factors team, designing and implementing a business-driven "Science & Evidence" roadmap to support current and future drug delivery devices.Drive user-centered, evidence-based initiatives to ensure the safe and effective use of our products.Lead cross-functional...

  • Technical Software Specialist for Medical Device Development

    vor 1 Monat

    Bern, Bern, Schweiz CASCINATION AG Vollzeit

    Job DescriptionWe are seeking a highly skilled Technical Software Specialist to join our team at CASCINATION AG. As a key member of our software development team, you will be responsible for designing, implementing, and testing desktop software applications using C++ and QML.Key Responsibilities:Software Development: Design, implement, and test software...

  • Product Manager Business Development

    vor 6 Monaten

    Bern, Schweiz Kambly SA Vollzeit

    Die Marke Kambly ist die bekannteste und beliebteste Biscuitmarke der Schweiz und gilt im Premium-Segment des Feingebäcks als weltweiter Qualitäts - und Innovationsführer. Um dem positiven Geschäftsverlauf und den künftigen internationalen Wachstumsambitionen gerecht zu werden, suchen wir zur Verstärkung unserer Abteilung Business Development eine...

  • Scientist - Process Development and Optimization

    vor 6 Monaten

    Bern, Schweiz CTC Resourcing Solutions Vollzeit

    **_The Life Science Career Network_** **Scientist - Process Development and Optimization** Our client, a large pharmaceutical organization, is looking for a Scientist Process Development and Optimization to join the BioProcess Development team for a **12-month contract (with possibility for extension) in Bern**. **Main responsibilities**: - Play an...

  • Software Architecture Expert for Medical Device Development

    vor 4 Wochen

    Bern, Bern, Schweiz CASCINATION AG Vollzeit

    Company OverviewCASCINATION AG is a Swiss medical device company committed to enhancing medical treatment outcomes. Our robotic and image-guided solutions empower clinicians to deliver reproducible and efficient interventions across various disciplines.

  • Scientist - Process Development and Optimization

    vor 6 Monaten

    Bern, Schweiz We make it Vollzeit

    Beschreibung: We make it GmbH is a company operating nationally in Switzerland which, thanks to many years of successful experience, has a high level of competence in the personnel services sector. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH...

  • Scientist / Process Development and Optimization

    vor 6 Monaten

    Bern, Schweiz We make it GmbH Vollzeit

    We make it GmbH is a company operating nationally in Switzerland which, thanks to many years of successful experience, has a high level of competence in the personnel services sector. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest...

  • Technical Product Owner SAP ABAP Development

    vor 1 Monat

    Bern, Schweiz Post CH AG Vollzeit

    Als Product Owner SAP ABAP Developmentvertritts du die Produkte Vision im betreuten DevOps Team imBereich der klassischen ABAP Entwicklung (RICEFW) OnPremis(R3/S4).Basierend auf dem priorisierten ARTBacklog und den für das DevOps Team benötigten Enablern pflegst undpriorisierst du das Product Backlog auf Team-Ebene und schreibstdie User Stories...

  • Product Owner

    vor 7 Monaten

    Bern, Schweiz ITech Consult Vollzeit

    **Project/Role**: For our customer from the finance industry in Bern we are looking for Product Owner Marketing Automation Platform to be responsible for the effective ICT product development of the Marketing Automation Platform as well as maximizing value creation for stakeholders in an agile environment. **Main tasks**: - Responsible for IT product...

  • Technical Product Owner SAP ABAP Development

    vor 2 Wochen

    Bern, Schweiz Aequor Consulting GmbH Vollzeit

    Für unseren national und international bekannten Kunden aus der Logistik Branche, der sich laufend über Unternehmenskäufe und -verkäufe sowie Beteiligungen entwickelt, suchen wir einen Technical Product Owner SAP ABAP Development (m/w/d) 80-100%. Arbeitsort : Bern und Home Office - Je nach Vereinbarung. In dieser spannenden Rolle verantworten Sie unter...

  • Technical Product Owner SAP ABAP Development

    vor 2 Wochen

    Bern, Schweiz Aequor Consulting GmbH Vollzeit

    Für unseren national und international bekannten Kunden aus der Logistik Branche, der sich laufend über Unternehmenskäufe und -verkäufe sowie Beteiligungen entwickelt, suchen wir einen Technical Product Owner SAP ABAP Development (m/w/d) 80-100%. Arbeitsort : Bern und Home Office - Je nach Vereinbarung. In dieser spannenden Rolle verantworten Sie unter...

  • Scientist - Bioprocess Development (M/F/x)

    vor 6 Monaten

    Bern, Schweiz ALTOGEN AG Vollzeit

    **ALTOGEN** is a swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to expert...

  • Scientist - Bioprocess Development (M/F/x)

    vor 7 Monaten

    Bern, Schweiz ALTOGEN AG Vollzeit

    **ALTOGEN** is a swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to expert...

  • Head of IT Platform

    vor 1 Monat

    Bern, Schweiz HELVETICA PARTNERS Vollzeit

    Head of IT Platform (Medical Device Sector) - SEMWe are currently looking on behalf of one of our important clients for a Head of IT Platform (Medical Device Sector). The role is a permanent position based in Bern Canton with good home office allowance.Your Role:Oversee the personnel & financial management of an IT Platform Services division.Hold operational...

  • Software Development Specialist for Android Applications

    vor 3 Wochen

    Bern, Bern, Schweiz Universität Bern Vollzeit

    Job OverviewWe are seeking a skilled Software Development Specialist to join our team at the Universität Bern. The successful candidate will work primarily on integrating the university's Android application with third-party medical devices, contributing to research efforts and clinical trials.

  • Senior Director Regulatory Group Lead

    vor 1 Woche

    Bern, Schweiz CSL Plasma Vollzeit

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Product Enablement Manager

    vor 1 Monat

    Bern, Schweiz Comfone Vollzeit

    We live in a connected world. Whether you are chatting to loved ones overseas, or depending upon connected healthcare devices, reliable connectivity is essential and therefore we provide easy and borderless communication to all people and things. Comfone is a pioneer in global international roaming services, a market in constant technological evolution. We...

  • Looking for Tech Co-Founder

    vor 2 Wochen

    Bern, Schweiz Startupticker Vollzeit

    Looking for Tech Co-Founder - ideation stageLooking for a Technical Co-Founder for an Android Launcher App - I am building an Android Launcher that transforms your smartphone into a distraction-free “dumb phone” during scheduled hours (details in the attached document). The ideal candidate has expertise—or a strong interest—in Android development, is...

  • Analytical Technologies Expert

    vor 2 Wochen

    Bern, Bern, Schweiz CSL Behring AG Vollzeit

    Job SummaryWe are seeking an experienced Analytical Technologies Expert to join our team at CSL Behring AG. As a key member of our Quality Control group, you will be responsible for developing and implementing new analytical methods and technologies to support the quality and safety of our biologics products.About the RoleIn this role, you will work closely...