Senior Program Manager- R&D - Medical Device

Senior Program Manager- R&D - Medical Device Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States Country United States Shift 1st About the Position Introduction Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Werfen Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA. Job Summary: Plan and manage a large multi-functional product development project and/or several small multifunctional product development projects simultaneously. The projects may include large multi-functional projects or a combination of hardware, software, and sustaining projects. The position requires strong, enthusiastic leadership skills in a highly technical medical instrument product development environment. Provide direct supervision to program managers and project managers who are responsible for the projects or major subprojects within the program. Participate in business strategic planning representing current projects and implementing the business strategy. The position requires regular interaction with all functions and levels of the organization from R&D scientists and engineers, marketing/sales, quality/regulatory, and operations, through executive management. Directs the program team and project team(s) in a manner to achieve the business results expected. Forecast program results when requested. Seeks guidance on unusual and complex problems whose solution exceeds the approved project or program boundaries. Authority of position is that required to carry out assigned duties, except where expressly reserved by the senior management personnel or Werfen Corporate/Division Policy. Responsibilities Key Accountabilities Essential Functions: Program Leadership : Provide technical and team leadership to one or more large project team(s) or program team(s). This may include directly leading one of the projects. Leadership entails planning, scheduling, assignment of work, and technical support within the program area. Drive the successful attainment of program goals. Project Planning and Scheduling : Responsible for project or program planning and scheduling, clarifying and defining the scope of work, utilizing deliverable milestone methods and critical path scheduling, conducting resource planning and allocation, and developing task and project estimates. Generates integrated project plans that meet business objectives and are in compliance with the design control process, while maximizing resource efficiency. Project Execution and Control : 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 program and project plans that are within approved program and project boundaries.Plan and conduct major program and supporting project and milestone reviews. Agile Project Management : Participates in the decision-making process regarding when to employ the Agile methodology. Ensure adequate resources are applied to Agile projects. Problem Solving Leadership : Responsible for coordination of program and project resources to identify the root cause(s) of program and project issues, and develop and manage a plan to fix, test, and implement an appropriate solution through completion. Risk Management Leadership : 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. Identify risk trends and patterns across the program and develop risk mitigation strategies for systemic risks. Design Control : Creates and maintains file to current phase ensuring accuracy. Ensure compliance with Design Control practices. Communication : Responsible for program communication for both within the project team(s) and between the team(s) and executive management. Vendor Management : Responsible for ensuring adequate oversight and control of vendors providing development, test or technical services that support the project. Cross Department Collaboration : Responsible to establish communication channels with commercial functions, support team and infrastructure to ensure successful on market change(s) and/or new product introduction. Uses input from commercial functions to influence and execute program plan. Conflict Resolution : 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 a creative, professional climate that will maximize the contributions of the technical staff. Resource Allocation : Ensures that adequate equipment and material resources are available to advance the program and project(s) and achieve goals and objectives. Works with other program and project managers to ensure the best use of shared resources. Supervision and Employee Performance : Demonstrated functional management expertise and skills in developing, mentoring and coaching others. Works with functional management participating in skills/gap assessments and conducting coaching for project core team members. Provides direct supervision to Program Managers and Project Managers assigned to the program. Strategy Development : Lead activities focused on improving the efficiency and effectiveness of the product development processes and procedures. Budget Managed: Prepares and maintains budgets for the portfolio of programs and projects. Annual budget between $5 million and $10 million Networking/Key Relationships: Works with functional management to conduct performance appraisals and coaching for project core team members. Provide regular supervision for assigned Project/Program Manager(s). To be determined based on department and project 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 Minimum Knowledge & Experience Required for the Position: BS in STEM or management discipline of MS/MBA Additional course work in accounting, business economics, strategy development, resource management and project management is desired At least 10 years of experience, preferably in product development with at least 5 years of successful technical leadership, project coordination, or project management are required Experience in the development and release of at least one successful product launch of a medical instrumentation product is desirable Certification in program management is preferred Full and comprehensive knowledge of the complete product lifecycle, including all aspects of product development from conception to manufacturing introduction Skills & Capabilities: Leadership Functional/technical skills Analytical Skills Problem-solvingng, 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 Travel Requirements: Less than 15% of the time. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact View email address on click.appcast.io for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. #J-18808-Ljbffr Werfenlife SA.