Job Description

Years of Experience

11 - 18 years

Workplace Type

On-site

Seniority Type

Senior

Industry

Medical Devices

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Analyse Salary

Skills

Product RegulatoryComplianceTestingRequirements GatheringSystems Engineering

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Wasim Shaikh

Talent Advocate at WhiteCrow

Description

About our client

Our client is an American multinational healthcare company. For over a century now, they have delivered on their commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world. At the intersection of progress and purpose, they are redefining what it means to be a global medtech leader. Their forward-looking leadership team is a driving force in ensuring we meet the needs of all our stakeholders-every day and everywhere. They strive to create lasting value by empowering their patients, protecting the planet, and championing people and communities.

Job description

Responsibilities:

• Responsible for delivering R&D programs, leading the efforts in the coordination and management of the product systems architecture and systems level design, including the decomposition of the system architecture and requirements into subsystem and interface specifications.
• Have clear Understanding of Unmet Needs, define scope, Use-cases driven system requirements by Prioritizing feature, and identifying dependencies & inadequacies for different products such as Infusion pumps and its accessories
• Be a Liaison between Marketing, Clinical, Regulatory, Serviceability, HW/SW, Risks and Cybersecurity
• Drive decisions through ambiguous situations by Understanding the big picture, Challenges in realizing the feature, resolve conflicts and negotiate between upstream and downstream teams.
• Conduct Market Research, Driving Digital Initiatives and Competitive benchmarking through defined framework
• Performs the activities associated with the Systems engineering of one or more products in various stages of the product lifecycle from new product development to post market surveillance.
• Thorough understanding and drives application of phases of life cycle management.
• Ability to apply life cycle management principles across all phases of life cycle management.
• Gathers inputs for Requirements from various sources such as Standards, User needs, Regulatory, Quality, Human factors, Manufacturing, Service and so on. Performs impacts assessment on the requirements on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigation. Come-up with the recommended mitigation with the rationale.
• Understands clinical and user needs and can apply to product realization. Creates and maintains Design History File elements.
• Leverages knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective.
• Drives adherence to FDA, ISO and IEC design control procedures, regulations and standards.
• Can perform as an independent reviewer in technical and design reviews.
• Establishes, maintains and actively develops associations with cross functional business partners and/or functional peers across our organization.
• Utilizes creative thinking and teamwork to resolve conflicts.
• Makes proficient and disciplined critical decisions and systems deliverables (e.g. program milestones, technical design reviews).
• Embraces team and management decisions while also raising issues to appropriate level.
• Identify and define high level requirements for a product or a feature that enhance the quality of therapy
• Will work with Risk and Compliance Manager within Medication Delivery to ensure compliance of product solutions with global standards requirements. Will also support efforts to comply with global environmental regulations.
• Expedite, manage, and coordinate interrelated systems activities across functions, within the constraints of human and financial resources and changing priorities.
• Participate in identifying and planning tasks, activities, and resourcing needs related to systems engineering.
• Facilitate an improved understanding of the interrelationship between Requirements, Risk and Reliability.
• Creates design concepts and research methodologies that best meet current and future customer & business needs for a product or process domain area.
• Successfully influences stakeholders and cross-functional team members within the project.
• Initiates, develops and leads technical feasibility analysis for product or subsystems; translates customer/user needs to product needs.
• Proposes and drives solutions to complex technical problems that are ambiguous and diverse in scope.
• Teaches and mentors others in life cycle management methodologies.
• Lead teams through credibility and influence.
• Coordinates efforts of cross functional teams and/or integrates cross functional inputs to delivery of a project of moderate technical and strategic complexity.
• Ensures cross-functional review, discussion and debate of input; identifies and prepares appropriate stakeholders within functional, program and/or project team to make decisions.
• Ensures inclusion of inputs into product and technical design reviews from all cross functional stakeholders.
• Understands and contributes to resolution of competing constraints among inter-related functions (e.g. engineering, manufacturing, regulatory, marketing) required to deliver products to market.
• Works with Project Management to create and manage schedules for systems and sub-systems.
• Plan, schedule, and lead project assignments using appropriate engineering techniques, processes, and methods with minimal guidance

• Must possess a strong knowledge of engineering disciplines and solid knowledge of related disciplines, Electromechanical, Systems, Fluid Mechanics, Materials Sciences
• A demonstrated track record in electromechanical system development, preferably medical devices, or other highly regulated products.
• Success in delivering results on technical challenges including investigative and problem-solving skills
• Have a proven track record of management/leadership effectiveness in a fast-paced environment.
• Proven ability to create results within budget, timeline, and product/project deliverables.
• Has organized and presented technical and project overviews without assistance
• Strong team player, able to meet deadlines and handle changing priorities
• Experience in resolving complex technical problems using strong analytical skills
• Excellent written, oral and interpersonal skills
• Must be proficient at time management and multitasking

WhiteCrow