A medical device engineering professional and manager who, working with little or no supervision, applies advanced scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete complex assignments related to Parkinson's Disease infusion pumps. The Therapy Domain Engineering Leader has full knowledge of other related engineering disciplines beyond their own area of expertise as they apply to a high performing infusion pump. This individual will become intimately familiar with the therapies being administered by our infusion system. They will lead the development, testing, and design improvement decisions for the devices to better meet the needs of our patients. They will manage and oversee the testing team for their pump platform.

Additional Responsibilities Include:

• Reviews, understands, and evolves legacy infusion system architectures, design input/outputs and verification packages.
• Establishes and drives Operations S&T infusion systems practicum to develop and sustain products in the market.
• Mentors colleagues on the craft of infusion pump engineering.
• Responsible for planning, reviewing/approving, and overseeing the delivery of Verification Plans, test cases, testing protocols, test execution and testing reports to meet project timelines.
• Responsible for leading and directing the verification testing team of lab technicians and engineers to ensure testing plans are executed and testing workloads are balanced.
• Responsible for compliance with applicable policies and procedures. Ensures quality and effectiveness of key results of major projects within function through sound design, early risk assessments, and implementation of fallback strategies. 
• Has full awareness of the potential consequences (defects and failure modes) of design changes to established processes. Mitigates risk within functions through sound design, early risk assessments and implementation of fallback strategies.
• Identifies, plans, and conducts medium- to large-size projects requiring custom, risk-managed execution plans, investigations, and/or equipment changes. Manages multiple, often concurrent, projects and meets deadlines. 
• Maintains project controls and reporting for cost, scope and schedule; develops execution strategy including procurement; balances multiple demands within an Understands the business needs of the company
• Has a thorough knowledge of the customer and clinical needs when developing a project scope. 
• Incorporates business foresight of emerging technological trends. 
• Analyzes business forces (customers, suppliers, competitors, technologies, government regulations) in major markets to identify trends and recommend responses. 
• Independently executes, and/or directs others in the execution of the design of products/processes/equipment/systems/facilities by applying novel engineering theories, concepts, and techniques within the disciplines; experiments, often with multiple variables, gathers data, and performs detailed analysis. 
• Supports requirements development and maintenance.
• Assists the identification and implementation of product and process improvement.
• Perform system requirement analysis, functional analysis, and integration system testing.
• Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.
• Publish research in peer-reviewed journals and present work at scientific/technical conferences. Proactively seek out new information in the literature and incorporate this into individual project(s) as well as the overall program.
• Seize opportunities to pursue project relevant leads that are in line with the group’s strategy. Maintain a high level of presence in the lab and sub-system and system level testing/analysis productivity.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable.
• May mentor/supervise a team of one or more and guide and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.
• Designs and leads complex experiments, often with multiple variables, gathers data, and performs detailed analysis. Assesses relevance. Conceptualizes complete solutions. Creates or coordinates the design solutions for novel or complex problems; integrates regulatory and operational needs; assesses cost benefit. Explores multiple alternatives.  Structures studies and integrate cross-disciplinary and cross-functional issues to arrive at optimal cause of action.
• Applies technology in innovative ways. Combines technologies to anticipate or address customer needs; shares solutions across sites; employs proven solutions to increase effectiveness of engineering methodology or manufacturing process. Mentors others by sharing technical expertise and providing feedback and guidance. 
• Where appropriate, provides tasks/project assignment opportunities for employee development and evaluates performance. Represents the organization as the prime technical contact on contracts and projects. 
• Interacts with both senior management and external personnel on significant technical matters often requiring coordination between organizations. Submits articles for internal or external publication.  Acts as a trusted advisor.  Balances bottom line objectives of a project with long-term interest of customer. Is identified as a Subject Matter Expert in the discipline. Participates in internal teams to develop and align procedures and standards.