Job summary

Our Client is seeking an experienced Systems Engineer who will perform systems engineering work requiring expertise in all aspects of product development.

Fixed term Role of 12 months. No Contractors as this an employed role.

Key skills required for this role

Senior Systems Engineer - Medical Devices

Important

Senior Systems Engineer - Medical Devices

Job description

Position Summary
An experienced Systems Engineer who will perform systems engineering work requiring expertise in all aspects of product development, who over time will become a recognised technology / product subject matter expert. This position may require coaching and mentoring of other engineers.

Essential Duties & Responsibilities

• Acts as a Systems Engineer on assigned new product introduction projects.

• Responsible for systems engineering deliverables on assigned projects including requirements management, risk management, creating design specifications, verification and validation execution, requirements traceability, standards mapping and assurance cases, while assuring that design activities proceed per requirements.

• Oversees engineering development activities of major significance, which are highly difficult and complex in nature.

• Operates with wide latitude for un-reviewed action or decisions.

• Maintains frequent communications within and outside of department in support of engineering activities, such as project management meetings, project review, etc.

• Guides the decision-making process, conducts meetings, and makes presentations for assigned projects.

• Acts as a recognised expert in systems engineering, providing technical advice and direction to other members of the engineering team

• Provides innovative approaches to problem resolution. Represents Our Client with customer groups and technical forums.

• Commitment to maintain awareness of new scientific knowledge / technology in relevant fields and ensure regulatory compliance for all products.

• Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

• Other duties as assigned by supervisor.

Knowledge & Skills

• Knowledge of systems engineering as applied to medical device development including requirements management, risk management, design specifications, verification and validation execution, requirements traceability and standards mapping.
• Expert knowledge and skill in hardware product development documentation procedures, development methods and project management, with the ability to rapidly master hardware product development procedures and methods.
• Knowledge of SOPs, FDA/ISO 9001/ISO13485/FDA 510K, etc., principles and skill in integrating into hardware product development discipline.
• Ability to utilise creativity, foresight, and mature judgement in anticipating and solving unprecedented problems.
• Ability to lead, establish, maintain and influence effective working relationships with internal customers within the region and across functions.
• Ability to work with vendors and internal departments to resolve department issues and contribute toward project and organisational objectives.
• Ability and willingness to facilitate change - changes in policy, procedure, technology and culture.
• Ability to work with integrity and build trust.
• Strong analytical and problem-solving skills
• Ability to handle multiple priorities and to meet key deadlines under pressure through effective time management skills
• Ability to clearly convey ideas and concepts verbally and in writing
• Ability to coach and mentor others in technical matters.
• Ability to plan and conduct effective meetings and group presentations.
• Ability to work with vendors and internal departments to resolve department issues and contribute toward project and organisational objectives
• Fluent in English

Minimum Qualifications, Education & Experience

• Scientific or Engineering University Degree.
• Education requirements can be obtained through an educational institution or gained through equivalent work experience.
• Extensive post graduate experience in Systems, Mechanical or Electronic hardware development.