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MillenniumSoft Inc · 6 hours ago

Manager, Project/Program Management - Exp in NPD Projects & Medcal Device Industry (onsite)

Irvine, CA

Full-time

Onsite

Senior Level

6+ years exp

MillenniumSoft Inc is seeking a Manager in Project/Program Management to lead teams through product development and commercialization in the medical device industry. The role focuses on managing large-scale projects, ensuring adherence to quality standards, and facilitating effective communication among stakeholders.

Staffing & Recruiting

Responsibilities

Manage one or more large-scale projects/programs, ensuring strict adherence to BD's Quality Systems and Change Control Process

Facilitate the creation and approval of business cases within the program and coordinate the sharing and prioritization of resources among projects

Develop a detailed plan for the program and manage program changes accordingly

Implement program strategies related to quality assurance, risk management, communications, staffing, and other core areas. and communicate program status and data to maintain accurate and current program information for stakeholders

Facilitate core team meetings and other required meetings to support program execution; regularly assess and enhance meeting processes, decision-making, and workflows

Serve as a project and program management subject matter expert, including guiding and mentoring peers

Demonstrate high emotional intelligence; build trust, rapport, and respect with project team members and stakeholders; engage in honest and transparent conversations

Create a culture where teams can act with a high sense of urgency and accountability to meet/exceed individual and project goals

Understand complex problems and drive the team to effective resolution

Display perseverance and maintain appropriate forward momentum by keeping the core team engaged, even when faced with crises and/or changes

Demonstrate strong ability to influence downward, horizontally, and upward

Qualification

New Product DevelopmentMedical Device RegulationsProject ManagementAgile MethodologiesMS Office SuiteSoftware/Firmware DevelopmentAnalytical SkillsEmotional IntelligenceDecision-MakingAttention to DetailTeam LeadershipCommunication Skills

Required

A minimum of 6 years of direct experience managing New Product Development projects and/or programs of increasing complexity

Demonstrates a record of successfully managing and leading projects in the medical device industry that incorporate a mix of Software, Firmware, and Thermoplastic Hardware and Disposable components

Proficient understanding of Medical Device Regulations and Product Development Process

Demonstrated record of leading within complex organizations require strong management skills

Proven expertise in the usage of MS Office Suite and related project management systems

Ability to see the 'big picture' and determine the course of action from an overall 'best for the business' perspective

Strong analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions

Ability to work cooperatively at all levels in a matrix environment to build and maintain the positive relationships required to accomplish organizational goals

Demonstrated proficiency in decision-making, with the capability to negotiate and balance priorities across multiple functional departments. Makes timely decisions in the face of risk and uncertainty

Bachelor's Degree in (Mechanical, Biomedical, Systems, Electrical) Engineering or related field