(Senior) R&D Process Engineer

Reposted 5 Days Ago
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Munich, Bayern, DEU
In-Office
Senior level
Healthtech
The Role
As a (Senior) R&D Process Engineer, you will design, implement, and optimize software development processes in compliance with medical device standards, collaborating cross-functionally to enhance process excellence and support R&D efficacy.
Summary Generated by Built In
Company Description

At the forefront of health technology for over 35 years, Munich-based Brainlab digitizes medical workflows, from diagnosis to therapy, to offer clinicians and patients better treatment possibilities. Our innovative digital ecosystem forms the basis for modern healthcare technology in 4000 hospitals in 120 countries.  

Our key to success is our creative, talented and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25 locations worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values curious, authentic and useful. 

Job Description

We are seeking a dedicated (Senior) Process Engineer within our R&D Office at Brainlab.

You’ll be joining a cross-functional team composed of experienced Process Engineers and Agile Coaches who play a pivotal role in shaping and evolving Brainlab’s product development landscape. This team is responsible for the governance, optimization, and continuous improvement of development processes across the R&D organization. They are aligning with the R&D tool ecosystem, and ensure that our working model and tools are harmonized to support efficient, high-quality product delivery and collaborate with stakeholders across R&D, Quality Management, and Product Management to drive process excellence and foster a culture of agility and innovation.

In the role of (Senior) Process Engineer, you will be responsible for designing, implementing, and continuously improving development processes to ensure compliance with international standards and regulations, while also enabling efficient and innovative development practices across our R&D teams.

Your tasks include:

  • Design, implement, and optimize software development processes within R&D in accordance with relevant medical device standards (e.g. ISO 13485, MDR/FDA).
  • Analyze effectiveness and efficiency of existing processes and manage process improvement and associated tool projects
  • Work cross-functionally with R&D, Quality Management, Quality Assurance and other interfacing departments to maintain a compliant yet efficient development environment
  • Ensure audit readiness and support internal and external audits related to R&D processes.
  • Align development processes within the Brainlab agile methodology
  • Provide process training and coaching to R&D colleagues and facilitate knowledge sharing across the organization.

Qualifications

  • University degree in engineering or life sciences preferred, but other degrees may be considered
  • Professional experience in the design and development of medical devices or in leading process optimization initiatives
  • Knowledge of medical device related standards and regulations such as FDA 21 CFR Part 820 and ISO 13485
  • Flexibility to adjust processes to align with an evolving working model
  • Solution orientation and a structured nature
  • Strong communication and documentation skills and ability to work cross-functionally
  • Fluent in written and spoken English, German is a plus

Additional Information

  • A mutually-supportive, international team
  • Meaningful work with a lasting impact on medical technology
  • 30 vacation days, plus December 24th and December 31st
  • Flexible working hours as well as hybrid work model within Germany
  • Bike leasing via cooperation partner "BikeLeasing"
  • Parking garage and safe underground bike storage
  • Award-winning subsidized company restaurant and in-house cafes
  • Variety-rich fitness program in our ultra-modern 360m2 company gym
  • Regular after work, team, and company events
  • Comprehensive training and continuing education opportunities

Ready to apply? We look forward to receiving your online application including your first available start date and desired salary. 

Contact person: Elisabeth Karro

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The Company
HQ: Munich
1,473 Employees
Year Founded: 1989

What We Do

Brainlab is a digital medical technology pioneer founded in 1989 and headquartered in Munich. The company employs more than 2000 people in 25 locations around the globe. Brainlab serves physicians, medical professionals and their patients in over 6000 hospitals in 121 countries. Brainlab creates software-driven medical solutions that digitize, automate and optimize clinical workflows for neurosurgery, spine, trauma, craniomaxillofacial (CMF), general and vascular surgery as well as radiotherapy and radiosurgery. Core products center around surgical navigation, radiotherapy, digital operating room integration, and information and knowledge exchange. The Brainlab open framework operating system will allow third parties to develop medical applications to further advance the field of spatial computing and mixed reality. Brainlab is dedicated to creating an impact in healthcare. The company connects opportunities from emerging digital technologies to transform healthcare at scale and help improve the lives of patients worldwide.

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