Job Summary:
Werfen North America is a family-owned, innovative company specializing in diagnostics across various medical fields. They are seeking an IVD Software Program Manager to lead product development projects, ensuring successful execution and collaboration across multiple departments to enhance patient care and hospital efficiency.
Responsibilities:
• Provide technical and team leadership to one or more small project team(s) or a program team, including planning, scheduling, and technical leadership within the program area. Drive the successful attainment of program/project goals.
• Responsible for project or program planning and scheduling, clarifying and defining scope of work, utilizing deliverable milestone methods and critical path scheduling, conducting resource planning and allocation, and developing task and project estimates. Generates an integrated project plan that meets business objectives and is in compliance with the design control process, while maximizing resource efficiency.
• Responsible for conducting regular project or program team status meetings and reviews. Ensures deliverables are completed and documented. Identifies the need for and implements changes to the project plan that are within approved project boundaries. Plan and conduct major project milestone reviews.
• Assume the role of Product Owner for Agile teams that are within the program. Define story requirements and approve deliverables at the Sprint demo.
• Responsible for coordination of project resources to identify the root cause(s) of project issues, and develop and manage a plan to fix, test, and implement an appropriate solution through completion.
• Responsible for ensuring program and project risks, both technical risks and management risks, are identified and appropriate risk mitigation plans are included within the program and project plan. Regularly assess and report the status of overall program risk remaining on a program.
• Creates and maintains file to current phase ensuring accuracy
• Responsible for program communication for both within the project team(s) and between the team(s) and executive management.
• Responsible for ensuring adequate oversight and control of vendors providing development, test or technical services that support the project.
• Coordinates discussions with commercial functions (operations, regulatory, distribution, customer support, marketing, sales, service, affiliates, etc.) through established communication channels to support on market change(s) and/or new product introduction.
• Able to resolve program and project team conflict through the application of good listening skills and negotiating skills. Able to remove oneself from the problem. Fosters creative, professional climate that will maximize the contributions of the technical staff.
• Participates in activities focused on improving the efficiency and effectiveness of the product development processes and procedures.
• Prepares and maintains program budget
• To be determined based on department needs, to include interactions such as: Coordination of review of documentation with Quality and Regulatory disciplines, Communication of product changes with Manufacturing / Operations disciplines, Communication of plans and status of projects with Marketing discipline, Communication of plans and status with other programs and projects within R&D.
Qualifications:
Required:
• BS in STEM field (engineering, chemistry, physics, etc.)
• Minimum of 7 years in project management or 5 years in product development
• Experience in design and development of medical instrumentation desirable
• Certification in project management or program management is desired
• Leadership Skills
• Problem solving, conflict management, listening, managing and measuring work
• Strong project management skill set and familiarity with project management tools and techniques
• Team player, self-motivated, perseverance
• Strong oral and written skills
• Word, Excel, PowerPoint, Design Control
Company:
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. Founded in 1959, the company is headquartered in Bedford, USA, with a team of 1001-5000 employees. The company is currently Late Stage.