Projekt-/Programm-/Portfoliomanager

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Mission

Interim manager Managing Director (3 Years) • Projectmanagement (10 Years) • Riskmanagement (2 Years) • Changemanagement (3 Years) • Processmanagement (2Years) • Supplymanagement (3 Years)

Zertifikate

  • Certificate in Program and Project Management (PPM)

Schwerpunkte

  • Change-Management

Branchenkenntnisse

  • Medizintechnik / Optik

Weitere Skills

  • Internationales Projektmanagement

Berufserfahrung seit

Juli 1987

Sprachen

  • Deutsch
  • Englisch

Ausbildung

sonstiges

Projekterfahrung

  • Project Manager / Sub Team Lead (Clinical Automation) In

    resource planning and supervision

    Looking at ways to reduce waste and increase efficiency

    Technical documentation

    Leading, developing, motivating and managing the work force.

    Create, control, coordinate and manage an environment for effective and economic production of quality product.

    Document management

    Lead, direct and manage the communication between the departments

    Monitoring performance by gathering relevant data and statistical reports
    Follow all company’s filed procedures and protocols
    Cooperate with other line managers and share information across the Organization
    Comprehend customer requirements and make appropriate recommendations/briefings

    Working with purchasing staff to establish quality requirements from external suppliers

    Interface for other Departments like EE, QA, Procurement, Software

    Creation of Project plans and Milestone supervision

    Coordination of construction, production, purchase, logistic.

    Setting up and maintaining controls and documentation procedures

    Drawing Inspection

    Making suggestions for changes and improvements and how to implement them

    Concept Inspection

    Design Inspection

    Document review

    Technical documentation for the FDA

    Change Management

    Kaizen

    EMV

    FMEA

    Risk Management (ISO 14971)

    Look for new supplier

    DBS Leadership

    Requirement Management

    Requirement Analysis

    Experience with ISO 13485

                                                               Experience with DIN EN 60601

                                                               Design Control

                                                              

    01/2012 – 04/2013                             Bombardier

    Project leader (self-service work)

    Software Change Request

    Budget tracking

    Lead, direct and manage the communication between the departments

    Monitoring performance by gathering relevant data and statistical reports
    Follow all company’s filed procedures and protocols
    Cooperate with other line managers and share information across the Organization
    Comprehend customer requirements and make appropriate recommendations/briefings

    Planning, organizing and supervise the achievement of goals on different time scopes Manage the resources

    Coordination of software development, testing, quality,
    logistic

    Leading, developing, motivating and managing the work force

    Making suggestions for changes and improvements and how to implement them

    Engineering Budget Request

    Creation of project plans and milestone supervision resource planning and supervision

    Technical documentation

    Document management

    V-Modell

    Projectplanning und Controlling

    Termin controlling

    Budget planning

    Progress controll

    Change- / Konfiguration-Management

    Risikomanagement

    Multiproject management

    Programm management

    Quality management

     Tools (MS-Project) und MS-Office (Word, Excel, Powerpoint)

    Life Projektmanagement

    Document management

  • Remediation of the Design History Files for the FDA

    resource planning and supervision

    Technical documentation

    Document management

    Leading, developing, motivating and managing the work force

    Work with the FDA (21CFR Part820)

    Experience with ISO 10007

    Experience with ISO 14971

    Experience with ISO 13485

    510K

    Creation of Project plans and Milestone supervision

    carry out DHF remediaiton activities as per approved remediation plan

    develop protocols and procedures

    technical writing-reports and technical justification

    develop understanding in functional / system testing of medical devices

    Remediation for the FDA

    Interface for RA

    Interface for the QM

    Design Control

  • Project Manager Manufacturing Process Information

    To work with Suppliers / Manufacturing Sites to document the process flow

    Monitoring performance by gathering relevant data and statistical reports

    Build positive relationships with customers and suppliers

    To work with Suppliers / Manufacturing Sites to create the Production Risk Assessment

                 To work with Suppliers / Manufacturing Sites on the

                 different requests coming from the Tech Files SME's

                             To work with Suppliers / Manufacturing Sites to ensure         

                             ontime identification / escalation / mitigation of risks

                 To ensure on-time weekly status reporting

                 To manage the projects in accordance with Company

                 objectives.

                 To work with Suppliers / Manufacturing Sites to ensure

                 Project Commitments and Due Dates are met.

    To manage the projects in accordance with Company objectives.

    To ensure health and safety of all internal end external employees working on his projects and that there is no impact as to quality.

    Responsible for the whole execution of the projects.

    That all current legal standards, GMP and compliance are met.

    Ensure that the excellent interdepartmental relationships are maintained with all other Company depts.

    Monitors are coaches the project team members to ensure that this objective is met.

    To maintain a continual focus on cost awareness.

    Manage project expense and all capital budgets.

     

     Experience with ISO 14971

     Experience with ISO 13485

     CAPA

     Process implantation

     Process optimize

Sonstige Informationen

Main Focus

 

Team Lead Projektmanager

  • Projectmanager
  • Requirements Engineer
  • Changemanagement
  • Riskmanagement
  • Supplier Management

 

Technologie Know-how

  • Operating Systems
  • SUN Unix
  • Windows NT
  • Windows XP
  • Networks
    • Router
    • Networks TCP/IP
    • Routing (WAN/LAN)
  • Applikationen/Databasesystems
    • MySQL
    • MS Office (Word, Excel, Powerpoint, Visio, MS Project)
    • Clear Quest, Clear Case
    • SmarTeam
    • Mirage
    • EPDM
    • Solid Works
    • SAP
    • Windchill
    • AGILE
  • Methods Consulting
    • Projektmanagement
    • ITIL (in general)
    • SIX SIGMA (in general)
    • Qualitymanagement (in general)
    • Kaizen
    • SCRUM
  • Intersectoral
    • Controlling
    • Reporting
  • Special Skills
    • Business Prozesse