Overview
On Site
Full Time
Skills
Technical Direction
Lifecycle Management
Supervision
Reporting
Cadence
Product Development
Surveillance
Human Factors And Ergonomics
Product Design
Research
SAFE
SAP BASIS
Field Service
Manufacturing
ISO 9000
Design Controls
IBM Rational DOORS
Mentorship
Management
Electrical Engineering
Biomedicine
Systems Engineering
Mechanical Engineering
Software Engineering
Electromechanics
Medical Devices
Military
Computer Hardware
Analytical Skill
Problem Solving
Conflict Resolution
Communication
Job Details
Job Description:
Responsibilities:
Requirements:
- You will be responsible for supporting the overall technical direction and work for Client Acute Therapies products.
- Based on your technical skills, you will drive various portions of the product development cycle at stages ranging from feasibility through lifecycle management.
- You will review and approve design concepts/changes and provide general direction to technical staff, including ensuring that quality is built into the design during new product development and/or sustaining activities.
- Proactively supervising the program and developing strategies to mitigate technical risks is expected as well as reporting on the progress to senior management during routine cadence meetings.
Responsibilities:
- Perform the activities associated with the Systems Engineering of one or more products in different stages of the product lifecycle from new product development to post-market surveillance.
- Understand clinical and user needs and apply them to product realization.
- Capture inputs for Requirements from various sources such as Standards, User needs, Regulatory, Quality, Human factors, Manufacturing, Service, etc.
- Use knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a Systems perspective.
- Initiate, develop, and lead feasibility by crafting design concepts and research methodologies that best meet both current and future customer / business needs for a product or process domain area.
- Build and maintain Design History File elements and ensure traceability to requirements.
- Facilitate an improved understanding of the interrelationship between Requirements, Risk and Reliability.
- nticipate technical challenges and risk scenarios and then prepare, lead, and execute mitigation strategies to ensure safe and effective results.
- Resolve systems-related technical issues by applying problem-solving tools such as cause and effect diagrams, Pareto charts, etc.
- Propose and drive solutions to technical problems that are ambiguous and diverse in scope.
- Perform impact assessments 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 mitigations, then propose recommended mitigations with the rationale.
- Influence partners and multi-functional team members within the project.
- Drive consistency to FDA, ISO and IEC design control procedures, regulations and standards.
- Use various software tools and programs (e.g. DOORS) to complete the above responsibilities.
- Teach and mentor others in life cycle management methodologies.
Requirements:
- bachelor's degree in electrical, Mechanical, Biomedical, Controls, Systems, Software or other related technical/engineering field.
- 3+ years of industry work experience.
- Must possess sound knowledge of systems engineering and related areas such as electro- mechanical and software engineering.
- demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardware.
- Demonstrated strong analytical and problem-solving skills.
- Success in working with multi-functional, global teams.
- Excellent interpersonal/communication/influencing skills.
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