- This role is accountable for driving complex product development efforts from conception to manufacturing stability.
- Ensure Design Control processes are followed per relevant procedures; FDA 21 CFR Part 820 and IEC62304 experience a plus.
- Driving a portfolio of product design projects
- Ensure Design Control processes are followed per relevant procedures.
- Facilitate and ensure that complex, high-value Business Unit projects are properly scoped, resourced, and communicated to minimize risk, deliver on-time and on-budget.
- Organize and manage phase gate review meetings.
- Creating and maintaining project schedules.
- Develop and monitor project budgets.
- Provide clear communication to the organization on project status, critical path, as well as potential areas of risk.
- Work closely with Product Development, Manufacturing, Marketing, Regulatory, and Quality organizations to ensure input and representation in the development process.
- Work closely with NPI counterparts to ensure prototypes, supplier and manufacturing activities are scheduled and tracked appropriately.
- Contributes to product prioritization steps by providing data and research from current and past projects.
- Provides feedback to team members regarding performance and requirements.
- Build informal and formal communication channels to deliver information that is accurate and up to date to all stakeholders.
- Utilize corporate approved tools and implement them to empower and unencumber team members as they work to complete projects.
- Organize and guide large numbers of distributed, cross-functional resources successfully.
- Function as the primary point-of-contact for key stakeholders across the organization
- Minimum bachelors degree in an Engineering discipline required.
- 3+ years of experience involved in the development and commercialization of medical devices as a project management/program manager.
- Previous experience working with software/electrical/mechanical product development is required.
- Ability to drive many people on a variety of programs.
- Requires knowledge of engineering, product strategy and business management
- Experience in examining tradeoffs between product features, customer needs/requirements, produce-ability, and cost.
- Desired project tools experience includes CA Technology - Resource Management tool, JIRA, Confluence
- Experience in design transfer experience is desired.
- Ability to communicate effectively with executive leadership on the project status.
- Willing to go the extra mile with an excellent work ethic; self-directed and resourceful with the ability to deal with conflict and drive to solution.
- Proven ability to influence and work well at all levels of an organization and in a cross functional team environment.
- Ability to handle ambiguity effectively and oversee multiple projects at once.
- Demonstrated ability to synthesize data, set actionable goals and drive metrics and execution.
- High attention to detail and proven ability to manage multiple, priorities simultaneously; must work well under pressure, be flexible, and meet deadlines.
- Energetic person with a drive for results, who is accountable, has a great attitude, and is a team-player; self-starter with high degree of initiative, urgency, and follow through.
- Certification in project management (PMP) desired
- Competitive Compensation
- Flexible Scheduling
- Career Growth Opportunities
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Medical Device Project Manager - Los Altos, United States - INFOTRON
Description
Job Description
Job DescriptionJob SummaryWe are hiring a Project/Portfolio Manager for a client that designs and manufactures highly complex surgical systems including cameras, instruments, and accessories for use in surgery. You will manage Robotic Assisted Surgical Devices projects associated with the development of these products.
Roles and Responsibilities:
Skill/Job Requirements:
Type: Contract to Hire
Workplace: This is a hybrid role and you will be expected to be on-site few days a week. Number of days onsite will be decided by your manager.
Flexible work from home options available.