Program Manager - NPD

Sunrise Systems, Inc.; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Sunrise Systems, Inc. seeks an NPD Program Manager to lead new product development, clinical evaluations, and commercialization for advanced hemodynamic monitoring products within the APM PMO team in Irvine, CA.

You will drive programs from initial planning through execution, ensuring on-time delivery and adherence to quality systems. The ideal candidate has 6+ years in NPD management in medical devices with software, firmware, hardware, and disposables; familiarity with Agile/Scrum and PM

Qualifications

• 6+ years of hands-on experience managing New Product Developments projects and/or programs of increasing complexity.
• Medical device industry experience with software, firmware, hardware and disposables.
• Proficient understanding of Medical Device Regulations and Product Development Process.
• Ability to influence within complex organizations and manage cross-functional teams.
• Strong MS Office and project management tools proficiency.

Responsibilities

• Lead one or more large-scale NPD programs from planning through commercialization.
• Ensure adherence to Quality Systems and Change Control Processes.
• Develop detailed program plans and manage changes.
• Communicate program status to stakeholders and maintain current information.
• Lead core team meetings and drive effective decision making.
• Mentor peers as a project management SME.

Skills

NPD R&D

Cross-functional leadership

Agile/Scrum

Education

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

Master's Degree or equivalent – Preferred

Tools

Jira

Microsoft DevOps

Job description

Title: NPD (New Product Development) Program Manager

Contract Duration: 12 Months Contract

Only on W2 - No C2C

Technical Skills

Must Have

• Bachelor's Degree in (Mechanical, Biomedical, Systems, Electrical) Engineering or related field – Required
• NPD R&D
• Strong cross functional engineering management experience
• Working knowledge of Agile/Scrum methodology and related project management software: Jira, Microsoft DevOps, etc.

Nice To Have

• Master's Degree or equivalent – Preferred
• PMP Certification - Plus

Manager, NPD Program Management

Job Description:

• The NPD (New Product Development) Program Manager in client Advanced Patient Monitoring (APM) PMO Team will be responsible for successfully leading NPD teams through the various stages of product and algorithm development, clinical evaluations, operational readiness, and commercialization for new and improved 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 on-time commercialization of new products and technologies that uphold Edwards best in-class quality standards and business objectives.

Key Responsibilities:

• Manages one or more large scale to enterprise-wide projects within program, assuring strict adherence to client APM's 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 communicate 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 meeting/exceeding individual and project goals
• Understands complex problems and drives the team to effective resolution
• Displays perseverance and continues appropriate forward momentum by keeping core team engaged, even when faced with crisis, and/or changes
• Demonstrates strong ability to influence downward, horizontally, and upward.

Experience:

• A minimum of 6 years of hands-on experience managing New Product Developments projects and/or programs of increasing complexity -- Required
• Demonstrated track record of successfully managing and leading projects in the medical device industry that incorporate a mix of Software, Firmware, and Hardware and Disposable components – Required
• Proficient understanding of Medical Device Regulations and Product Development Process – Required
• 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 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 matrix environment to build and maintain the positive relationships required to accomplish organizational goals.
• Effective decision-making skills -- ability to negotiate and balance decisions and priorities across 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 in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Education:

• Bachelor's Degree in (Mechanical, Biomedical, Systems, Electrical) Engineering or related field – Required
• Master's Degree or equivalent – Preferred