Danaher Corporation Senior Design Quality Engineer - Hardware (m/f/d) in München, Germany
Join a team where you can be heard, be supported, and always be yourself. At Beckman Coulter, a Danaher company, we’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. At first glance, you’ll see we are dedicated to advancing and optimizing the laboratory to move science and health care forward for more than 80 years. Look again and you’ll see we are invested in you and you’ll have the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful. You’ll find the Danaher Business System, which makes everything possible. You’ll also see a company that investors trust—our culture of continuous improvement has helped us outperform the S&P 500 by more than 5,000% over the past 25 years.
And no matter where you look at Beckman Coulter, at the heart of what we do, you’ll witness our shared purpose—helping realize life’s potential—in action. Our work helps improve millions of lives. We hope you’ll see yourself here, too.
What you find at Beckman Coulter — and within yourself — might just change the world!
Do you want to provide guidance to the core team to organize project structure and documentation to meet design control requirements? Working with the Design Quality Manager, as Senior Quality Engineer you support new product development (laboratory automation and related software) from a QA perspective as well as design changes to established products.
200 employees work at our main office in Munich and the Quality Assurance team has a team size of 10 Associates.
Goal of the Position:
Closely engage in R&D projects towards introduction of new products as quality lead
Partner with Risk Manager and Complaint Manager to ensure compliance
Proactively provide guidance to maintain and improve compliance of development projects with global and local processes
Ensure conformity of the design process with applicable regulation
Drive improvement of development processes with the development teams
Represent QA function within the core teams in charge of the design change projects
Review and approve design and development documentation related to the products you are in charge
Develop and complete validation plans and protocols
Take ownership for DHF completeness and maintenance
Generate and maintain the risk management files
Drive risk assessments
Support post-market surveillance activities
Degree in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences
Work experience within the regulated environment preferably within in-vitro diagnostics or medical devices
Hardware development process experience or practical experience with product verification and/or validation
Experience in design verification and/or validation and generation of associated protocols for tests simulating end use or user acceptance tests
Proficient in English - written and verbal
Knowledge of ISO13485, ISO14971
High level of autonomy and critical thinking is required. Teamwork oriented.
Digital literacy (MS Office products)
Modern, virtual working approach in an exciting international environment.
Locations in the beautiful Munich area, close to public transportation.
Flexible working hours and hybrid working where possible.
Regular career and development cycles as well as salary reviews and a bonus system.
Active Diversity & Inclusion Council to ensure an inclusive work environment, equal opportunities and pay.
Company Pension Plan.
Contribution to the costs of the job-ticket of the public transportation of Munich.
Development: Danaher is a company that believes in continuous improvement — it is at the core of how we lead and operate our businesses. Whether refining our processes, our tools, or our products, the theme of evolution and getting better is fundamental to our DNA.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) 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’ve ever wondered what’s within you, there’s no better time to find out.