Loading some great jobs for you...
PURPOSE AND SCOPE:
Is an expert in therapy systems & their clinical use/practice. Acts as the technical leader responsible for defining the system architecture for new therapy systems. This refers to the complete therapy system which includes the active medical device, disposables, and interfaces at the point of care. Also responsible for defining the program roadmap taking into consideration the existing portfolio and the lifecycle management.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Responsible for system architecture of a therapy system. Responsible for evaluation and modification need for new features, the definition of system architecture for a new treatment therapy, and the definition of system architecture for new products.
Interfaces to Marketing, especially during pre-project phase and with regards to strategy & roadmaps.
Establishes policies appropriate for the function. Interprets and provides recommendations for change of company-wide policies and practices.
Participates as a member of Cross Functional Team for selected projects.
Determine and evaluate safety requirements at system level (machine + consumables + user).
Responsible for providing clarification of interface requirements.
Supports the definition of product performance characteristics.
Ensures that input from System Architect supports achieving defined goals (technology, performance, cost, quality, timelines).
Contributes to the preparation of and/or prepares documents within development process at different phases (e.g. MCND- Market Customer Need Document, PRID-Product Requirement Input Document).
Provides overall responsibility for and/or approval of relevant product and project documents from the PSA (Program System Architect) point of view.
Responsible for ensuring appropriate compliance of systems with applicable standards.
Provides approval of Overall Risk Sheet.
Supports design reviews.
Explains/defends product concepts to regulatory bodies and customers.
Supports the VP PSSA (Vice President, Program Strategy & System Architecture, Global Therapy Program) in technical and strategic issues.
Collaborates on the Therapy Program strategy and roadmap.
Determines/contributes to program, product, and therapy strategy to optimally address customer and company needs.
Contributes to technology screening and scouting (identifies and evaluates new ideas).
Contributes to benchmarking of third-party systems.
Evaluates 3rd party technology/devices and initiates appropriate measures.
Ensures all employees within the assigned team(s) understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations; establishing and maintaining effective internal systems and controls to promote compliance.
Provides technical guidance.
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
Ensures that budgets and schedules meet corporate requirements.
Assists with various projects as assigned.
Other duties as assigned.
Qualifications PHYSICAL DEMANDS AND WORKING CONDITIONS:
Various staff which may include System Architects and/or Project Managers.
Bachelors Degree in Engineering, Life Sciences or related field required; advanced degree preferred
EXPERIENCE AND REQUIRED SKILLS:
10+ years of related experience in product development with a focus on system architecture of medical devices/IT systems; includes 5+ years of experience in a senior managerial role.
Strong management skills with the ability to lead cohesive and productive teams.
Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.
Excellent oral and written communication skills.
Further education/experience in therapy system components and interfaces a plus.
Risk management knowledge/expertise.
Strong focus on quality.
Understands the health care environment.
Understands the development and regulatory requirements for medicinal products.
Proven track record in leadership skills/position.
Proven track record in leading cross functional teams.
Ability to work effectively in a matrix organization and in CFT.
Ability to explain complex technology, system architecture, and risk factors.
Ability to achieve consent and committed decisions.
Ability to make timely decisions.
Innovative and creative
Target driven, strong leadership skills, action oriented, excellent social skills, ability to lead a team to results and success.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Launch your career - Create your profile now!Create your Profile
Loading some great jobs for you...