\\n 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.
The associate senior hardware engineer will be responsible for managing equipment product care activities including hardware requirements, hardware development and verification & validation activities, maintaining the technical Dossier up-to-date, performing technological surveillance and will be working with internal and external stakeholders to keep state-of-the-art instrument on the market.
What you\\xe2\\x80\\x99ll do
Participate and represent R&D in the complaint handling investigation team, perform investigations, data analysis and experimental tests to identify root causes. Evaluate findings to formulate corrective action plan.
Collaborate and coordinate with a multidisciplinary R&D team to evaluate and resolve engineering and quality-related problems.
Take the lead to translate between the parties to facilitate customer support and quality-related problems resolution, in close R&D collaboration with the engineering and biological team matter experts.
Build working relationships with the customer support teams, field engineer and field application specialist teams and end-users (biotech or Pharma companies) and increase product knowledge across the customer facing teams.
Master processes and tools and take the lead on process/tools/document optimization to improve the overall change control and CAPA process efficiency in compliance with ISO9001 standards and other QMS requirements.
Regular reporting on customer feedback, CAPA trending and progress enabling product evolution.
Write technical documentation including root cause investigation, test plan and report, and user technical documentation for a wide range of target audience.
Assist with internal and external Quality audits and participate to market support programs.
Deliver on-time, communicate effectively, and resolve conflicts, encourage constructive dialogue within the cross-functional teams.
Acquire DBS knowledge and practice DBS processes
Who you are
University degree or equivalent in related scientific or engineering fields (physics, engineering, or life science). Bachelor\\xe2\\x80\\x99s or Master\\xe2\\x80\\x99s Degree with 6 years of relevant experience. Ph.D. with 2 years of relevant experience
Experience working with complex product in a multidisciplinary environment, ideally involving broad hardware, software, and single-use technologies. Relevant experience in the Life Sciences or medical sector.
Good theoretical know-how in understanding engineering disciplines and good understanding of human cell biology.
Technical knowledge of cell cryopreservation methods, especially in the context of immunology, is a plus
Expertise in statistical methods and tools for performing qualitative and quantitative data analysis
Ability to investigate and troubleshoot, strong critical thinking, analytical and problem-solving skills, and attention to detail.
Demonstrated ability to clearly communicate (oral, written) across global, cross-cultural, cross-functional teams and stakeholders
Knowledge and practical experience of relevant regulations (ISO 9001, cGMP), specifically for the US and European market
Customer-oriented mindset, autonomous at work, good organizational skills, creative, and comfortable with change
Fluent in English, a second language is a plus
When you join us, you\\xe2\\x80\\x99ll also be joining Danaher\\xe2\\x80\\x99s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you\\xe2\\x80\\x99ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
If you\\xe2\\x80\\x99ve ever wondered what\\xe2\\x80\\x99s within you, there\\xe2\\x80\\x99s no better time to find out.\\n \\n \\n \\n \\n \\n