Position Name: Project LeadLocation: San Diego, CADuration: Long Term Contract

Keywords: Project Management, Medical Domain, Risk Management, ISO 13485, Design Control Procedures (21 CFR 820).

Client Remark: We need to find the core experience candidates in Program Management and R&D in Medical domain.

Job Description:

• This leader will provide portfolio management leadership across multiple technical projects to ensure execution excellence and take project lead roles for select projects within the project portfolio defining the project scope and drive successful project execution. The role will effectively organize and motivate a highly skilled cross-functional team. This high visibility leadership role will present frequently across various levels.
• Executes a project of moderate to high complexity by leading cross functional teams individually. Analyzes development situations and data with in-depth evaluation of multiple factors.
• Influences solutions to business or technical problems. Communicates and implements the strategic and technical direction for the project team. Demonstrates a working knowledge of business drivers and influences business case development. Complete understanding of a wide application of project management principles, theories & concepts.

Educational Background

• BS degree in Mechanical Engineering, Materials Science & Engineering, Biomedical Engineering, or a closely related engineering degree is required. An advanced degree in an engineering discipline or MBA is preferred.

Professional Experience

• At least 5-8 years relevant experience in product development and design in medical devices/products along with program/project leadership experience in medical devices/products.

Job Responsibilities

• Lead a cross-functional team, including R&D, Quality, Regulatory, Medical, and Manufacturing resources in managing and executing projects in support of global medical products.
• Provide portfolio management leadership across a number of technical projects to ensure clear communication, proactive identification of risks and execution excellence.
• Collaborate with the global platform leadership team including reviewing of portfolio projects and managing priorities.
• Lead and support execution of technical and/or cross-functional project work
• Gives clear visibility to the leadership on the execution of the projects and work on the risk proactively with mitigation for the project execution with cross function.
• Support the portfolio of current products in terms of quality and regulatory compliance, manufacturing, and supply continuity.
• Ensure implementation and rigor of product development processes and design control procedures.
• Demonstrate strong and clear accountability for operational and program success.
• Demonstrate leadership, learning agility, and action orientation when facing uncertainty. Instill confidence through leadership and actions.
• Motivate the team to achieve individual and program objectives.
• Foster the development of team members to excel in their performance, both functionally and cross-functionally
• Contribute to a culture of innovation by proactively generating novel concepts to improve current product performance or enhance current products ability to address customer needs.
• Ensure compliance with BD quality policies, procedures, and practices.
• Ensure compliance with all local, state, federal, and BD safety regulations, policies, and procedures.

Knowledge and Skills

Knowledge

• Successful track record of leading cross-functional projects
• Experience in new product development planning multiple work-streams, identifying risk and implementing action plans to optimize timelines and reduce execution risk.
• Knowledge of high-volume manufacturing methods such as molding and stamping, and automated assembly and packaging processes.
• Demonstrated understanding of end to end product development process.
• Experience utilizing combination of analytical, statistical, computational, and empirical methods to gain deep understanding of design and minimize overall development timelines.
• Experience working with multidisciplinary teams with strong understanding of disciplined product development processes, regulatory, and quality requirements.
• Experience managing ambiguity.
• Demonstrated experience with all phases of the Design Control process (21 CFR 820)

Skills

• Demonstrated learning agility of new subject matter.
• Demonstrated ability to act as a change protagonist.
• Excellent interpersonal, communication, presentation and influencing skills.
• Proficiency in Microsoft Project or equivalent project planning software