Senior Engineer
Senior Engineer
Posted on :
22-05-2025
Employer Active
1 Vacancy
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Job Description
Job Description:
- You will be responsible for supporting the overall technical direction and work for novel 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 postmarket 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.
- Anticipate technical challenges and risk scenarios and then prepare lead and execute mitigation strategies to ensure safe and effective results.
- Resolve systemsrelated technical issues by applying problemsolving 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 multifunctional 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:
- A Bachelors 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.
- A demonstrated track record in electromechanical system development preferably medical devices or other highly regulated products such as military hardware.
- Demonstrated strong analytical and problemsolving skills.
- Success in working with multifunctional global teams.
- Excellent interpersonal/communication/influencing skills.
Employment Type
Full Time
Key Skills
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