Responsibilitiesarrow_right
* Provide leadership, goal-setting, communications, and facilitation skills to guide and motivate project personnel in a matrixed environment.
* Be able to lead project teams on a variety of complex projects such as concept development, design and process development, design transfers, and manufacturing transfers.
* Manage external contractors and vendors to ensure completion of projects per the agreed upon milestones and within budget.
* Responsible for tracking, monitoring and managing project schedules.
* Track and manage project budget to plan and identify and improve processes to reduce costs.
* Identify and manage resolution of potential deviations from the quote/contract, Project Master Plan or other project documents along with performing and managing project risk relative to the client and Freudenberg Medical.
* Identify and recommend appropriate resource allocations from all areas to support the project requirements and monitor their utilization/efficiency.
* Manage billing/invoicing activities on a monthly basis and provide monthly revenue estimates.
* Work with manufacturing team to develop the transfer cost of goods sold (TCOGS).
* Communicate with clients on a regular basis (as required) and provide monthly updates to Freudenberg Medical Management.
* Document project and team meetings minutes and distribute to appropriate management. Ensure client issues/deviations are resolved and documented in a timely manner.
* Communicate variances in project budgets, plans and schedules with clients, Business Development and Management. Negotiate necessary changes with clients.
* Assist Business Development to evaluate new business opportunities along with coordinating/developing quotes to close deals.
* Support contract development for product development and manufacturing projects.
* Coach and mentor Product Development Staff, providing feedback to managers and supervisors as needed.
Qualificationsarrow_right
* Bachelor of Science engineering degree, BSME or BSBME (or related discipline) and experience in the medical device field.
* 10+ years' experience in a program manager position for a manufacturing company in medical device industry.
* Demonstrated experience leading large complex programs with external and internal customers.
* Technical product development experience, e.g. design, process, or quality engineering.
* Working knowledge of MDR, FDA, and CE design controls
* Strong technical writing ability.
* Leadership ability and organizational skills.
* Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work.
* Proficiency in the use of PC and programs, particularly Project, Excel, Word, PowerPoint.
* Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) both to senior management, customers and associates.
* Execute tasks in a timely manner without direct supervision.
* Thorough understanding and working knowledge of ISO13485.
* Ability to prioritize tasks.
* Applies decision making & analysis tools to align stakeholders, document rationale and achieve optimum outcomes.
* Embedded utilization of Lean tools as necessary for new programs and continuous improvement.