Lead Expert App Development (Ref.Nr. RE2578)

Basel  ‐ Vor Ort
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Beschreibung

BRINE SA has been placing top IT specialists at well-known customers for over 30 years. In doing so, we focus on performance, competence, experience and partnerships.

We are looking for a Lead Expert in App Development, for one of our customers in Basel.

  • In order to support our expanding development of "Software as a Medical Device" (SaMD), we are looking for a Lead Expert App Development. The successful candidate is a recognized expert for development and maintenance of safety critical mobile and/or web applications and will take over the technical leadership for the software development part for projects classified as SaMD within the Packaging & Device Development Team.

  • The role includes early phase development activities, the management and monitoring of software development at our external partners, and the commercialization and maintenance of overall life cycle management as legal manufacturer. In addition to outstanding project management and interpersonal skills, a strong background in software development and life cycle management, as well as the use and implementation of platform technologies, is crucial for this role. The successful candidate will play a critical role in the support and sustainable expansion of the SaMD area.

Tasks and responsibilities

  • Technical leadership for the software development of mobile and/or web applications classified as SaMD

  • Providing software/systems life cycle expertise within a broader cross-functional drug product development team

  • Supporting the standardization of the entire SaMD life cycle management process in order to utilize cross-product synergies

Leading the collaboration with external development partners:

  • Support supplier selection, auditing and approval

  • Elaboration of development plans and contracts for upcoming projects

  • Monitor work progress according to plan

  • Monitor, support and challenge technical development and deliverables as well as change, test and release strategies

  • Support the deployment and implementation of a sustainable Product Life Cycle process in close collaboration with external and internal partners and stakeholders

  • Leading and/or supporting cross functional project teams during development, review and submission of regulatory dossiers

  • Leading risk management activities

  • Planning and monitoring of design verification activities

  • Leading and authoring technical documentation

  • Ensuring a high quality Design History File

  • Supporting the improvement of the SaMD QMS

REQUIREMENTS

  • MSc/MA in computer science or relevant field and excellent understanding of the current Agile development methods and technologies

  • Experience in project/program management of complex projects

  • Autonomous and independent working style with at least 7 years of experience as technical project management of projects with safety critical applications in a regulated environment

  • Team player who works efficiently in interdisciplinary teams

  • Experience in designing innovative software and systems architectures

  • Analytical thinking and problem-solving capability

  • Excellent understanding of software design and programming principles as well as in overall verification strategies, including test set-up and test automation.

  • Good communication and conflict management skills

  • Fluency in English language incl. technical writing Experience desired

  • Considerable experience of managing external suppliers

  • General understanding of Human Factors Engineering, risk management and clinical studies processes and requirements.

  • Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical

    Device Directive, EU Medical Device Regulation), including those related to medical software (IEC 62304)

  • Development and writing of technical documentation of drug/device combination products and medical devices, including the design control process and other applicable regulatory, QA and GMP aspects

  • Understanding of pharmaceutical development in general

To learn more about this opportunity please send your CV ASAP in Word format to Brine SA

Work location: Basel

Start: ASAP

Duration: 31.12.2019 possibility of extension (long-term Need)

Workload: 100%

Salary: Market Rate

Language: Proficiency in German

Ref: RE2578

BRINE SA has been providing its IT- and SAP specialists for short-, mid- and long-term projects in Switzerland since 1985, with customers primarily active in the following market sectors:

Financial services sector, especially banks and insurance companies

Pharmaceutical industry

Government and services sectors

BRINE SA is a stable, financially independent, Swiss enterprise with its head office in Zurich. Our services cover the entire IT spectrum, as well as interfaces to the various business sectors, and range from management- and IT-consulting through to software development and project implementation.

IT - Resources

We offer our top consultants, computer Profi's and SAP experts to our customers as external specialists for limited assignments and as well for permanent positions. BRINE SA is especially distinguished by its renowned characteristic strengths:

Short reaction time - rapid selection and supply of consultant's CVs, with skills matched to customer requirements.

Quality - we take quality very seriously, both for internal and external-facing processes, thereby convincing many customers to maintain a long-standing business relationship with BRINE SA

Coaching - BRINE SA coaches and supports its consultants throughout the entire duration of the customer assignment.

BRINE SA is ISO 9001:2008 certified since 2014

Start
ab sofort
Dauer
31.12.2019 +
(Verlängerung möglich)
Von
BRINE SA
Eingestellt
14.02.2019
Projekt-ID:
1719577
Vertragsart
Freiberuflich
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