(Senior) R&D Process Engineer

Brainlab; München; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work in Germany

Bike leasing

Parking and bike storage

Company restaurant

Job summary

Brainlab in Munich seeks a dedicated (Senior) Process Engineer for our R&D Office. You will design, implement, and continuously improve development processes to meet ISO 13485, MDR/FDA, and evolving standards while supporting efficient, compliant product delivery.

You’ll work in a cross-functional team with process engineers and agile coaches, ensure audit readiness, align with Brainlab’s agile methodology, and train colleagues across R&D for continuous improvement.

Qualifications

• University degree in engineering or life sciences preferred; other degrees may be considered.
• Professional experience in design and development of medical devices or leading process optimization initiatives.
• Knowledge of medical device standards and regulations such as FDA 21 CFR Part 820 and ISO 13485
• Flexibility to adjust processes to evolving working models
• Strong communication and documentation skills with cross-functional collaboration
• Fluent in English; German language skills are a plus

Responsibilities

• Design, implement, and optimize 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 related tool projects.
• Work cross-functionally with R&D, Quality Management, QA 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 Brainlab’s Agile methodology.
• Provide process training and coaching to R&D colleagues and facilitate knowledge sharing across the organization.

Skills

Fluent English

German language (nice to have)

Education

University degree in engineering or life sciences

Job description

At the forefront of health technology for over 35 years, Munich-based Brainlabdigitizesmedical 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,talentedand 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,authenticand 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 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