Trumpf Medical develops and manufactures medical equipment for operating rooms, intensive care units, and related clinical areas that provide high quality support for hospital staff and the efficient and safe care of patients. In hospitals and especially in the operating room, rapid, smooth workflows are of life-saving importance. Digital systems and automated devices are becoming more prevalent in order to help streamline workflows, improve user comfort and promote patient safety. In consideration of these developments, Trumpf Medical is setting new standards with its OR solutions.

Trumpf Medical is a part of Hillrom. Hillrom, with three global business units, has a comprehensive product line that delivers solutions in hospitals, doctors’ offices and long-term care facilities. With sales of approximately $2.7 billion, the Company employs more than 10,000 people around the world. It is pursuing an aggressive organic and acquisition strategy for growth.

We are looking for a Manager Design Assurance (m/w/d) for our location in Saalfeld (Thuringia) or Puchheim near Munich.

Manager Design Assurance (m/w/d)

Trumpf Medical develops and manufactures medical equipment for operating rooms, intensive care units, and related clinical areas that provide high quality support for hospital staff and the efficient and safe care of patients. In hospitals and especially in the operating room, rapid, smooth workflows are of life-saving importance. Digital systems and automated devices are becoming more prevalent in order to help streamline workflows, improve user comfort and promote patient safety. In consideration of these developments, Trumpf Medical is setting new standards with its OR solutions.

Trumpf Medical is a part of Hillrom. Hillrom, with three global business units, has a comprehensive product line that delivers solutions in hospitals, doctors’ offices and long-term care facilities. With sales of approximately $2.7 billion, the Company employs more than 10,000 people around the world. It is pursuing an aggressive organic and acquisition strategy for growth.

We are looking for a Manager Design Assurance (m/w/d) for our location in Saalfeld (Thuringia) or Puchheim near Munich.

Beschreibung

Development of strategies for oversight of new product development activities to ensure new product launches are successful

  • Provide Design Assurance leadership and expertise to strategically ensure policies and procedures are implemented and compliant
  • Ensure robust follow up on Design Mitigation Review and Design Review Committee action plans and commitments
  • Provide leadership and collaboration across functions to ensure the procedures are both efficient to use and compliant to Design Control, Risk Management or Statistical Technique regulations / standards

Responsibility to ensure the Product development process is compliant to regulations and is being followed within the GSS global business unit

  • Development, modification, or review for approval any procedure or tool related to product development
    Fullfillment of goals of the GSS R&D Entity Corrective Action Board (CAB) by ownership or participation in the completion of CAPAs
  • Responsibility for Design Assurance in the Sustaining Engineering team within GSS and ensure adherence to Design Control procedures as defined by Hillrom’s Quality System
  • Planning the needs of projects or other initiatives to meet company goals by working with the GSS project leaders, engineering management and operations management
  • Driving best practices from across Design Assurance, as well as any other source, into the QA/RA team

Leadership including staffing, budgeting, efficiency and effectiveness

  • Provide leadership and collaborate across functions to ensure the procedures are both efficient to use and compliant to Design Control, Risk Management or Statistical Technique regulations / standards
  • Management of cross-functional team dynamics and performance and prediction what people are likely to do in multiple situations
  • Directs activities related to design assurance including strategies, staffing, scheduling, coordinating, quality assurance standards, and planning
  • Objectively assess the strengths and development needs of each team member
  • Has the self-confidence to hire and assemble a strong team, as well as the ability to put them in situations in which they can excel
  • Holds employees, including peers, accountable to performance expectations, through timely and constructive feedback
  • Enforces compliance of personnel with administrative policies, procedures, governmental; ensures compliance with all applicable regulatory requirements
  • Support and ensure team preparedness for project milestone reviews including Phase Exits, Design Reviews, and Product Safety Committee

Ihre Qualifikation

Qualifications:

  • Undergraduate Bachelor’s Degree in a Science or Engineering discipline
  • 7+ years progressive and successful quality and regulatory leadership experience, preferably in the medical device industry
  • Proficient with Quality System Regulations, EU MDR, and ISO Quality System Standards including Risk Management (ISO 14971)
  • Proven in depth knowledge and successful application of Design Assurance, Reliability, and Product Development procedures, specifications, regulations and standards
  • Proven strong and effective interpersonal/communication/collaboration/negotiation skills
  • Proficient interpersonal and communication skills to interact cross functionally
  • Proven track record of strong analytical and problem solving skills
  • Ability to improve processes (Design Controls) and maintain compliance
  • Functional/technical knowledge and skills to perform a role at a consistently high level
  • Ability to communicate effectively with senior management, Hillrom Legal, external resources, and suppliers
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