R&D Process Engineer - Software Development

Brainlab; München; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A medical technology company is seeking a (Senior) Process Engineer to join their R&D team. The role involves designing and optimizing software development processes in alignment with medical device standards, ensuring compliance, and fostering process excellence. Candidates should have a degree in Computer Science and relevant experience in regulated industries. The position offers flexible working hours and a hybrid work model within Germany.

Leistungen

30 vacation days

Flexible working hours

Bike leasing

Subsidized company restaurant

Fitness program

Comprehensive training opportunities

Qualifikationen

• 3+ years of experience in software development in a regulated industry (medical devices preferred).
• Basic to intermediate proficiency in programming languages.
• Flexibility to adjust processes to evolving working models.

Aufgaben

• Design, implement, and optimize software development processes.
• Ensure audit readiness and compliance with international standards.
• Provide process training and coaching to R&D colleagues.

Kenntnisse

Experience in software development

Fluent in English

Knowledge of IEC 62304

Strong communication skills

Programming languages (e.g. Python, Java)

Ausbildung

University degree in Computer Science or equivalent

Tools

Scripting and automation tools

Jobbeschreibung

Company Description

Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2400 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 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
• 3+ years of experience in software development in a regulated industry (medical devices preferred)
• Experience in software architecture of large systems — Basic to intermediate proficiency in programming languages (e.g. Python, Java, …) and/or experience with scripting and automation tools to enhance process efficiency
• 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
• 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: Géraldine Ferrer