R&D SENIOR HARDWARE VERIFICATION & VALIDATION ENGINEER (m/f/d)

  • Cytiva
  • Eysins, VD, Switzerland
  • 28/04/2021
Full time Data Science Data Engineering Data Analytics Big Data Data Management Statistics

Job Description

Help us improve access to life-changing therapies that can transform human health
We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.

Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.

What you’ll do

Assess product specifications or change controls for improving the robustness, usability or the manufacturing of new and existing devices.

Write project technical specifications, execute development and perform verification and validation activities with focus on quality, compliance and execution rigor.

Derive test requirements from the specifications, define test plan and methodology, estimate effort and resources plan to cover design verification and validation campaign.

Set-up design of experiments (DOE) and perform verification and validation activities, and/or review plan and results within the hardware team, with focus on quality, compliance and execution rigor.

Establish acceptance criteria, sampling, assess through modelling or qualitative/quantitative testing, evaluate the performance.

Develop good practice guidelines for performing hardware or equipment verification and validation activities and organize standardization and harmonization within the hardware team.

Learn, master and ensure harmonization in the team of usage of tools used for development, verification and validation and project management.

Perform and document technical root cause investigation in close R&D collaboration with hardware, software, application and disposable kit system matter experts.

Work in close collaboration with other R&D team members, suppliers, Production, Supply Chain, Quality and product management.

Mitigate project technical risks, resolve issues, deliver on-time and communicate effectively.

Ensure compliance with ISO13485 or ISO9001 standards and other QMS requirements.

Who you are

University degree or equivalent in related engineering disciplines (physics, mechanics, electronics or similar)

15+ years of a successful experience in new product development, product care, project management and manufacturing science and technology, ideally for the medical or life science industry involving cross-functional teams.

Demonstrated experience in defining and managing verification and validation plan and execution.

Demonstrated experience in improving, developing or manufacturing multidisciplinary equipment platforms involving mechanics, electronics or low-level firmware needs.

Demonstrated ability to clearly communicate (oral, written) across global, cross-cultural, cross-functional teams and stakeholders

Founded knowledge and practical experience of the product lifecycle and relevant know-how about regulations such as ISO 9001, ISO13485, cGMP, specifically for the US and European market

Fluent in English, second language a plus

Result driven, autonomous at work, creative, initiatives welcomed

Who we are
Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.

Want to know more? Experience life at Cytiva on our Careers website , Instagram channel and LinkedIn page !

Cytiva is global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to advance and accelerate therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.

Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world.