Senior Program Manager - Medical Devices

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.

* 6 - 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 ISO
13485.

* 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.