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Embedded Software Medical Device Technical Expert
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Design, Engineering
Projektbeschreibung
Embedded Software Medical Device Technical Expert
You are an outstanding Software Developer with good knowledge of medical device regulations. Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!
Our client, an international pharmaceutical company, is looking for you!
Main Tasks:
- Lead technical development activities for Embedded software components of medical devices used in combination products, eg auto-injectors, pumps.
- Specify requirements (DIR) of software components and define architecture for future platforms, including liaison with teams developing internal systems.
- Working with human factors engineers to define the appropriate HMI and activities.
- ollaborate with electronics experts to ensure appropriate hardware defined for software requirements.
- Manage suppliers in the detailed software design, coding and documentation with consideration of medical device classification.
- Ensuring fail-safe operation through architectural design as well as Real Time error checking to prevent logical, numerical or HMI errors.
- Applying security protocols for wireless communication to pair and operate components of the system.
- Ensuring data security and integrity with consideration of FDA CFR Part 11.
- Planning and reviewing the verification and validation of the software to ensure safe and secure operation with attention to hardware and operating system environment and versions.
- Report in to the Device Project Leader and Delivery System Leader on all technical aspects related to the device development project.
- Generate Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems. Author and Reviewer of DHF documents such as Design Input Requirements, Component Specifications, Design Verification Plan and Verification Summary Report. Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects.
- Ensure device design development in compliance with the regulations and delivered to a high quality.
- Root cause analysis of out-of-specification product and develop robust solutions to prevent re-occurrence.
Your profile:
Ideally you bring at least 8 years of experience in software development with main focus on medical devices for parenteral administration. You got experience generating DHF documentation, including but not limited to design input requirements, technical specifications, design verification, design validation, and design transfer. You are organized and structured in your approach and able to drive a technical team to reach solutions that meet with drug development milestones.
Requirement for the role are:
- Excellent technical writing skills (eg, Design Controls)
- Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)and of combination products (US) and standards
- Good organization and communication skills in English
- General understanding of Human Factors Engineering and Risk management
- General understanding of pharmaceutical development
We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.
If you are the person we're looking for please submit your application. We're looking forward to getting to know you.
You are an outstanding Software Developer with good knowledge of medical device regulations. Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!
Our client, an international pharmaceutical company, is looking for you!
Main Tasks:
- Lead technical development activities for Embedded software components of medical devices used in combination products, eg auto-injectors, pumps.
- Specify requirements (DIR) of software components and define architecture for future platforms, including liaison with teams developing internal systems.
- Working with human factors engineers to define the appropriate HMI and activities.
- ollaborate with electronics experts to ensure appropriate hardware defined for software requirements.
- Manage suppliers in the detailed software design, coding and documentation with consideration of medical device classification.
- Ensuring fail-safe operation through architectural design as well as Real Time error checking to prevent logical, numerical or HMI errors.
- Applying security protocols for wireless communication to pair and operate components of the system.
- Ensuring data security and integrity with consideration of FDA CFR Part 11.
- Planning and reviewing the verification and validation of the software to ensure safe and secure operation with attention to hardware and operating system environment and versions.
- Report in to the Device Project Leader and Delivery System Leader on all technical aspects related to the device development project.
- Generate Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems. Author and Reviewer of DHF documents such as Design Input Requirements, Component Specifications, Design Verification Plan and Verification Summary Report. Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects.
- Ensure device design development in compliance with the regulations and delivered to a high quality.
- Root cause analysis of out-of-specification product and develop robust solutions to prevent re-occurrence.
Your profile:
Ideally you bring at least 8 years of experience in software development with main focus on medical devices for parenteral administration. You got experience generating DHF documentation, including but not limited to design input requirements, technical specifications, design verification, design validation, and design transfer. You are organized and structured in your approach and able to drive a technical team to reach solutions that meet with drug development milestones.
Requirement for the role are:
- Excellent technical writing skills (eg, Design Controls)
- Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)and of combination products (US) and standards
- Good organization and communication skills in English
- General understanding of Human Factors Engineering and Risk management
- General understanding of pharmaceutical development
We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.
If you are the person we're looking for please submit your application. We're looking forward to getting to know you.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik