Program Managers (Medical Device Development)

Job Title: Program Managers (Medical Device Development)

Pay Rate: $55 to $63/Hr

Duration: 12 Months

Location: Irvine, CA (Onsite)

Shift timing - 8 AM to 5 PM (Monday to Friday)

We are looking for Program Managers for our PMO team with the responsibility of successfully leading NPD teams through the various stages of product development, clinical evaluations, operational readiness, and commercialization for new and improved medical devices (Hemodynamic Monitoring products) and related accessories and disposables. This person will be responsible for initiating, planning, budgeting, executing, documenting, controlling, and managing all aspects of program(s), to ensure the on-time commercialization of new products and technologies

• Manages one or more large-scale to enterprise-wide projects within the program, assuring strict adherence to Quality Systems and Change Control Process
• Facilitates the creation and approval of business cases within the program, and coordinates the sharing and prioritization of resources among projects
• Develops a detailed plan for the program and manages program change accordingly
• Executes program plans (quality, risk, communication, staffing, etc.) and communicates program status and data to maintain accurate and current program information for the use of stakeholders
• Leads core team meetings and other necessary meetings to drive best-in-class program execution;
• Continually improves quality and effectiveness of how meetings are run, decisions are made, and how work gets done
• Serves as a project and program management subject matter expert, including guiding and mentoring peers
• Demonstrates high emotional intelligence; builds trust, rapport, and respect with project team members and stakeholders; Engages in honest and transparent conversations
• Creates a culture where teams can act with a high sense of urgency and accountability to meet/exceed individual and project goals
• Understands complex problems and drives the team to effective resolution
• Displays perseverance and continues appropriate forward momentum by keeping the core team engaged, even when faced with crises, and/or changes
• Demonstrates a strong ability to influence downward, horizontally, and upward.

Requirements:

• Bachelor's Degree in (Mechanical, Biomedical, Systems, Electrical) Engineering or related field.
• Master's Degree or equivalent – Preferred
• A minimum of 6 years of hands-on experience managing New Product Developments projects and/or programs of increasing complexity
• Demonstrated track 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 Processes
• PMP Certification - Plus
• Demonstrated track record of leading within complex organizations requiring strong influence management skills
• Proven expertise in 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 positive relationships required to accomplish organizational goals.
• Effective decision-making skills -- the ability to negotiate and balance decisions and priorities across the needs of several functional departments. Makes timely decisions in the face of risk and uncertainty

Additional Skills:

• Working knowledge of Agile/Scrum methodology and related project management software: Jira, Microsoft DevOps, etc.
• Strict attention to detail
• Ability to lead meetings with external representatives
• Adhere to all EHS rules and requirements and take adequate control measures to prevent injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control
• Demonstrated track record of leading within complex organizations requiring strong influence management skills
• 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.