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For Companies At a Glance
- Tasks: Lead engineering solutions for medical devices and enhance product connectivity.
- Company: Join a leading Medical Device Manufacturer focused on innovation and quality.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth.
- Why this job: Make a real impact in healthcare technology while collaborating with talented teams.
- Qualifications: Bachelor's degree in relevant engineering field and 5+ years of experience required.
- Other info: Ideal for problem solvers passionate about improving medical device performance.
The predicted salary is between 42000 - 84000 £ per year.
Global Head of Engineering / Manufacturing (Medical Devices)
Our client, a Medical Device Manufacturer, is currently looking to appoint an experienced Systems Engineer who will lead engineering technical insight within the business and develop engineering solutions for the existing product range or for new products. Additionally, the Systems Engineer will drive and oversee investigation and development activities from an engineering perspective.
This person will plan and evaluate network technologies to enable, enhance, and support connectivity and integration. This role will provide device integration engineering services to research areas including selection, acquisition and service, technical investigations, and clinical/technical problem-solving.
They will also lead quality improvement activities and suggest innovative solutions to technical problems.
Responsibilities of the Systems Engineer:
- Maintain an overview of all technical aspects of the io platform and cartridges including firmware, software, and system cartridge interfaces.
- Provide technical expertise at the system level to align technical teams on hardware and supply components.
- Assess existing system architecture and recommend improvements and enhancements.
- Maintain the instrument DHF.
- Plan and lead new hardware developments and a pipeline for the io and cartridge platform.
- Define the scope of verification testing and provide key support for verification and validation activities. Complete testing protocol and analyze reports.
- Prepare documents for and support regulatory submissions.
- Investigate and develop solutions and new opportunities in the io and cartridge platform.
- Monitor reliability and performance in the io platform.
- Steer requirements for software developments on the io platform.
- Support security management processes including risk and vulnerability analysis and related documentation associated with interconnected and integrated devices and systems.
- Interface with the R&D team to bring solutions to new and existing products including streamlining current processes and idea invention.
- Troubleshoot and investigate errors and faults, lead root cause analysis and plan remedial actions.
Education, Experience and Demonstrated Skills:
- Bachelor’s degree in Clinical Engineering, Biomedical Engineering, Systems Engineering or related engineering field.
- At least 5 years’ experience in health-care or molecular engineering with demonstrated experience with FDA QSR and ISO 13485.
- Experience developing products in IVD diagnostic development, including use of statistics in experimental design.
- Strong understanding of mechanical, electronic, and software design principles.
- General understanding of molecular biology, focused on PCR and sample preparation.
- Strong skills in management of engineering projects and/or personnel.
- Ability to diagnose and solve technical and/or system problems of a high degree of complexity.
- Knowledge of electronic, mechanical, and/or computer reengineering design and applications principles.
- Knowledge of clinical systems architecture used for medical device interoperability.
- Strong level of computer literacy and the use of word processing, spreadsheets, databases, graphics, statistics, engineering tools, and programming.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Medical Equipment Manufacturing
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System Engineer employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land System Engineer
✨Tip Number 1
Familiarize yourself with the latest trends and technologies in medical device engineering. This will not only help you understand the current landscape but also allow you to speak confidently about how your skills can contribute to the company's goals.
✨Tip Number 2
Network with professionals in the healthcare and biomedical engineering fields. Attend industry conferences or webinars to connect with potential colleagues and learn more about the challenges they face, which can give you insights into how you can add value as a Systems Engineer.
✨Tip Number 3
Prepare to discuss specific examples of your past projects that align with the responsibilities listed in the job description. Highlight your experience with FDA QSR and ISO 13485, as well as any innovative solutions you've implemented in previous roles.
✨Tip Number 4
Showcase your problem-solving skills by preparing for technical questions during the interview. Be ready to explain your approach to troubleshooting complex systems and how you have successfully led root cause analyses in the past.
We think you need these skills to ace System Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in systems engineering, particularly in the medical device field. Emphasize your familiarity with FDA QSR and ISO 13485 standards, as well as any specific projects that demonstrate your technical expertise.
Craft a Strong Cover Letter: In your cover letter, express your passion for medical technology and how your background aligns with the responsibilities of the Systems Engineer role. Mention specific experiences where you led engineering solutions or improved product performance.
Highlight Technical Skills: Clearly outline your technical skills related to mechanical, electronic, and software design principles. Include any experience with molecular biology, especially PCR and sample preparation, as this is crucial for the role.
Showcase Problem-Solving Abilities: Provide examples of complex technical problems you've solved in previous roles. Detail your approach to troubleshooting and root cause analysis, as these skills are essential for the Systems Engineer position.
How to prepare for a job interview at Cpl Life Sciences
✨Showcase Your Technical Expertise
Be prepared to discuss your experience with system architecture, firmware, and software. Highlight specific projects where you provided technical insight or developed engineering solutions, especially in the medical device field.
✨Demonstrate Problem-Solving Skills
Prepare examples of complex technical problems you've solved in previous roles. Discuss your approach to troubleshooting and root cause analysis, emphasizing your ability to lead investigations and develop innovative solutions.
✨Familiarize Yourself with Regulatory Standards
Since the role involves regulatory submissions, brush up on FDA QSR and ISO 13485 standards. Be ready to explain how you've navigated these regulations in past projects and how they impact product development.
✨Engage with the R&D Team's Vision
Understand the company's current products and future goals. Be ready to discuss how you can interface with the R&D team to streamline processes and contribute to new product ideas, showcasing your collaborative spirit.
