About the position
Zepto Life Technology is currently seeking an experienced Engineering Program Manager – Medical Devices – to lead a cross-functional product development team. This newly created position will lead, direct and organize the planning and execution of a new product development project from concept to commercialization. The role will achieve successful implementation of the project and manage all activities required to define, design, develop and deliver a new IVD technology.
Leads and implements the technology and product development program.
Lead core team towards program objectives.
Leads internal project teams, including the management of product development team activities, the program schedule, budget, scope and the overall design to program objectives, with ultimate responsibility for on-time, on-budget product execution.
Responsible for control and communications of project/program level risks, issue management, and project quality.
Responsible for core team and cross-functional communications.
Manages core team members, although members formally report to functional heads.
Builds team ownership and commitment to project plan; mentors and/or coaches functional managers and team member performance.
Manages the technical challenges of technology application and new product development; identifies, communicates, and manages moderate to high levels of technical risk.
Develop a comprehensive program plan, which identify objectives, strategy, risks/risk mitigation, budget, effort estimates and schedule for new product development.
Manages key initiating, planning, executing, controlling, and closing processes.
Drive leadership of issue identification and issue resolution within the program across business units.
Leads team to complete activities to current policies and practices; keeps documentation organized, creates Scaling Plan and Design History File for the project.
Ensure departmental compliance as well as appropriate departmental resources are available to effectively maintain the quality system.
Identifies process improvements affecting the project.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Communications and Reviews:
Leads phase and business reviews, project meeting minutes, issues log, metrics, and other key communications.
Communicates and influences resolution of cross-functional issues.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Required: 510K experience
Strong leadership skills, including the ability to set goals and provide constructive feedback respectfully to build positive relationships and improve business results.
Excellent verbal and written communications skills. Must be able to convey business and technical concepts to a diverse customer base and to internal technical teams in a clear and concise manner. Knowledge of business and management principles involved in resource allocation, leadership techniques, production methods and coordination of teams with many disciplines ranging from management to staff to technicians.
Strong organizational, planning, and follow-up skills and ability to hold others accountable.
Experience with all phases of new product development, from concept through commercialization required
Must have knowledge of medical device technology, including the development cycles for one or more of software, mechanical and electrical disciplines
The ideal candidate will also have
8 years of Program management working with cross functional teams. PMP Certification. Fluency in MS office applications and MS Project.
10 years of medical device experiences. Experience in design, development and manufacturing transfer of medical devices essential.
Systems engineering experience • Minimum of 4-year degree in the sciences, preferably engineering.
Experience with ISO 14971 IEC 60601, IEC 62366 & IEC 62304
Understanding of FDA, ISO 9001 and ISO 13485 required