The main responsibility of this role is to oversee the development and engineering of two or more projects of low to medium complexity, which may span multiple sites. You will guide both internal and external stakeholders, as well as cross-functional teams, to achieve the project's goals and ensure successful execution within the set budget, timeline, and quality standards. Key aspects of the role include leading team members, managing project deliverables, creating and monitoring project plans, assessing and mitigating risks, and maintaining an integrated schedule of critical activities to meet all commitments. Additionally, you will be expected to introduce and apply Program Management Office tools and best practices within your function, site, or across the organization.
Role & Responsibility:
*Adhere to core values and all safety, environmental, security, and quality requirements, including Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, FDA regulations, company policies and procedures, and other regulatory standards.
*Manage and execute multiple projects of varying complexities from start to finish, ensuring that all projects are:
*Compliant with customer agreements, billing events, and milestones
*Financially tracked in line with cost management and revenue recognition standards for Non-recurrent Engineering (NRE) and/or sales of sample, prototype, or verification units
*Ensure each project is completed on time and within budget, meeting key performance objectives, resolving issues, and managing project and scope changes in alignment with initial agreements.
*Collaborate closely with cross-functional leaders to plan, develop, and direct product development and/or engineering projects from initiation through successful implementation and hand-off.
*Prepare, monitor, and ensure adherence to master project plans, quotes, budgets, specifications, and schedules, providing periodic status reports as needed.
*Establish Key Performance Indicators and milestones for project execution; provide organization, leadership, and guidance to project/program teams, and participate in relevant business teams as assigned.
*Act as the primary escalation point for project issues. Handle requests for service or information related to projects, prepare for and participate in status meetings, and provide updates to management, customers, and suppliers as necessary.
*Identify and recommend improvements to business processes and Program Management Office tools to enhance effectiveness and efficiency; share best practices across stakeholders and PMO functions, and incorporate these practices into the PMO Manual.
*Manage planning and communication with other functions (marketing, quality, regulatory, design assurance, manufacturing, etc.) regarding project initiatives and policies.
*Resolve issues or risks related to assigned projects effectively, representing the best interests of external customers, internal teams, and the overall business.
*Support the commercial team by providing inputs for new opportunities and quote development, which may involve visits to customer and supplier sites to assess technical capabilities and requirements.
*Engage with and ensure adherence to Product Development Process (PDP), Manufacturing Transfer Process (MTP), and Technical Development Process (TDP) systems, as applicable.
*Provide mentoring and training to Associates within cross-functional teams or others as required.
*Manage up to 2 to 3 direct reports, such as engineers or technicians, setting goals and supporting their personal and professional development plans.
*Perform other duties as required.
Skills & Experience:
Minimum Education:
Bachelor's degree in Engineering or a related technical field preferred; Master's degree in business or a technical field is a plus.
Certification in Project/Program Management from an accredited institution is preferred.
Minimum Experience:
Over 7 years of experience, including at least 4 years in a regulated product environment (such as medical devices, pharmaceuticals, automotive, or aerospace) and 3 years in project management, having led multiple projects and teams.
Knowledge & Skills:
Special Skills:
Proven ability to lead team activities.
Strong coaching skills.
Advanced critical thinking and problem-solving abilities.
Excellent communication, presentation, follow-through, and organizational skills.
Effective collaboration and conflict resolution skills, with the ability to work both vertically and horizontally across the organization and cross-functionally.
Specialized Knowledge:
Understanding of current FDA, ISO, MDD, and other relevant quality and regulatory requirements related to design control and product development.
Knowledge of product and process development engineering principles sufficient to contribute to product and technology development program ideation, scoping, initiation, and execution.
Travel:
Willingness to travel domestically and internationally as needed, up to 30% of the time.