You’re an important part of our future. Hopefully, we're also a part of yours! At B. Braun, we protect and improve the health of people worldwide. This is also our vision for research and development. You see complexity as an opportunity – and quality and sustainability are important criteria for your work. We would like to work with you on tomorrow’s solutions. That’s how we work to create sustainable healthcare – locally, in regions, countries and worldwide. Together. That's Sharing Expertise.

Manager/ Sr. Manager - R&D Governance
Reference Code R&D00026-57659

Duties and responsibilities

  • Implement the organisation's R&D strategy by managing and overseeing the activities (as stated below) in order to solve problems by sustaining, improving and generating new design development procedures, processes, systems, components and products :
  • a) Standards/tools/methods
  • Scope covering but not limited to Applied standards and monitoring; Review, analyze & reporting of new/amendments in standards; Establish and monitoring of SOPs; System / Tools for project management, research & development activities.
  • b) Requirements Engineering and Process Assurance
  • To evaluate and monitor development procedure/SOP/documentation/specification/records and to ensure they are in compliance with daily practice/operation of the development process. Support the development SOP and procedural documentation creation from the Ideation Phase until the Production Start-up Phase. Scope covering but not limited to REACH requirements, biological substances, regulatory affairs compliance; Support internal & external audit; Initiate and monitoring of periodic reviews for Development Process/Documentation; To propose and to implement Corrective Action needed to align the compliance of development practice and documentation.
  • c) Risk management and usability engineering
  • Scope covering but not limited to Risk Management and Usability Engineering/Human Factors Engineering; Implement risk management and product risk analysis.
  • d) Controlling and Administration
  • Scope covering but not limited to Cost Controlling; Investment & Budget Plan & execution; Administration day to day work.
  • Manage the day to day activities of the team whose activities may include devising research/development/technical methods; review and reporting; preparing technical specifications and recommendations.
  • Lead the most complex, controversial, or significant projects; evaluate findings; and prepare detailed reports with recommendations and conclusions.
  • Estimate the costs, resources, and time required to implement the organisation's annual R&D goals and monitor the performance of research/development/ technical projects to ensure targets are met.
  • Establish and maintain ongoing relationships with the external community.
  • Select, and manage ongoing relationships with suppliers and vendors to ensure the organisation receives satisfactory standards of service.
  • Lead, direct, evaluate, and develop a research/ development/technical team to ensure that research/ development/ technical activities are conducted within established budgets and according to established standards and procedures.
  • Ensuring compliance of the technical documentation for Product-Risk & Usability Methods as local Method Expert for CoE-IV-Access.
  • Moderation and Documentation of Elements of Product Risk and Usability Management acc. to ISO 14971:2019, IEC 62366-1:2020 and FDA Guideline for Human Factors 2016.
  • Support risk management and usability inputs for operations related process eg, Change Control, CAPA, Health Hazard Analysis, etc.
  • Ensure proper risk management and usability documents implementation into project and operations process.

Professional competencies

  • Master of Science in Natural Sciences/Engineering, preferably Safety Engineering or Quality Engineering or Medical Technology or similar qualifications (PhD in Engineering preferred).
  • At least 5 years of experience in leading teams.
  • Must be able to ensure the methodological compliance for Risk & Usability Methods within Medical Device Development & Lifecycle-Management.
  • Must have profound knowledge of ISO 14971:2019, IEC 62366-1:2020 and FDA Guideline for Human Factors 2016, and medical device regulations in an international environment. (MDR 2017, FDA Code 820ff).
  • Experience in usability test moderation acc. to IEC 62366-1 and FDA Human Factors Guideline preferred.
  • First-Hand experience in patient treatment preferred.
  • Quick understanding and the ability to compliantly adapt general standard-requirements to specific circumstances (Decisiveness/ Good Judgement Skills).
  • “Compliance first” mindset.
  • Experience in project management preferred.

Personal competencies

  • Profound intercultural communication skills.
  • Profound knowledge of English in speech and writing preferred.
  • Willingness to travel.
  • Able to contribute to team success.
  • a customer-centric person.
  • Able to lead within the organization.

What we offer

Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.

Closing date

2021-05-14