Job Description
We are seeking a dedicated and experienced (Senior) Process Engineer for software development processes 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 for software development, 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 software 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., IEC 62304, ISO 13485, ISO 14971, MDR/FDA).
* Work cross-functionally with R&D, Quality Management, Quality Assurance to maintain a compliant yet efficient development environment
* Ensure audit readiness and support internal and external audits related to R&D processes.
* Align software development processes within the Brainlab agile methodology
* Provide process training and coaching to R&D colleagues and facilitate knowledge sharing across the organization. — Align and integrate tools that support process automation and collaboration within R&D
Qualifications
* University degree Computer Science or equivalent
* Knowledge of IEC 62304 and its successful implementation in organizations
* Knowledge of other medical device software related standards and regulations such as FDA 21 CFR Part 820 and ISO 13485 desired
* Solution orientation and a structured nature
* Strong communication and documentation skills and ability to work cross-functionally
* Experience in software development in a regulated industry (medical devices preferred)
* Basic to intermediate proficiency in programming languages (e.g. Python, Java) and/or experience with scripting and automation tools to enhance process efficiency
* 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: Géraldine Ferrer