Location: null
Great that you&#**Apply on the website**;re thinking about a career
with BSI!
We are seeking a Medical Device Design Engineer to join our team as a
Technical Specialist. Candidates must have technical design and
development expertise in one or more of the following devices areas:
Respiratory, Anesthesia, Urology, Soft Tissue Implants
(Reconstruction/Medical Aesthetics Implants, Hernia/Abdominal Repair
Implants, Gastro-Intestinal Implants, Neurological Implants,
Obstetrics and Gynecological Implants, Closure Devices, Implantable
Hemostats, Embolization Beads, Bariatric Devices, Renal System
Implants, Pulmonary Devices).
Our Technical Specialists are industry experts that are analytical,
communicative, diligent, and always curious. If you are looking for a
career change to the regulatory side of the medical device industry
and want to make an impact on patient safety ? this may be a great
fit for you! This is a home-based position with up to **Apply on the
website**% travel (when COVID-**Apply on the website** travel
restrictions lift).
Essential
RESPONSIBILITIES:
Deliver Medical Device CE Marking technical reviews under MDD and MDR
requirements, scheme management and ISO **Apply on the website** QMS
assessment services.
Provide advice and support on certifications in area of expertise that
may have a regulatory challenge.
Participate in client meetings to facilitate CE marking processes.
Provide Medical Device expertise leadership and mentoring in areas of
competence to medical devices personnel.
Provide ?Technical Sales/Networking? support as needed
The ideal candidate will possess the following characteristics:
Bachelor&#**Apply on the website**;s degree or higher in a discipline
relevant to medical device design, manufacture and use, or equivalent
qualification.
At least five (5) years&#**Apply on the website**; post-graduate
experience in the design and development of one or more of the
following devices:
Respiratory, Anesthesia, Urology, Soft Tissue Implants, including the
principles of design control, risk management and performance and/or
clinical evaluation
Ability to lead and manage multiple projects with internal and
external clients.
Knowledge of medical device regulations.
Awareness of certification business processes, the application of
quality management standards, and audits What we offer:
BSI offers a competitive salary, ample annual leave/paid time off, and
other robust benefits depending on country.
Our Excellence Behaviours:
Client-centric, Agile, Collaborative. These three behaviours represent
how we do things at BSI. They help us ensure that BSI is a great place
to work and a highly successful business.
BSI is an Equal Opportunity Employer and we are committed to
diversity.
To protect our candidates and BSI employees during the Covid-**Apply
on the website** outbreak, all interviews will take place remotely. Position: ?Medical Device Design Engineer (Remote)
Location: null
Great that you&#**Apply on the website**;re thinking about a career
with BSI!
We are seeking a Medical Device Design Engineer to join our team as a
Technical Specialist. Candidates must have technical design and
development expertise in one or more of the following devices areas:
Respiratory, Anesthesia, Urology, Soft Tissue Implants
(Reconstruction/Medical Aesthetics Implants, Hernia/Abdominal Repair
Implants, Gastro-Intestinal Implants, Neurological Implants,
Obstetrics and Gynecological Implants, Closure Devices, Implantable
Hemostats, Embolization Beads, Bariatric Devices, Renal System
Implants, Pulmonary Devices).
Our Technical Specialists are industry experts that are analytical,
communicative, diligent, and always curious. If you are looking for a
career change to the regulatory side of the medical device industry
and want to make an impact on patient safety ? this may be a great
fit for you! This is a home-based position with up to **Apply on the
website**% travel (when COVID-**Apply on the website** travel
restrictions lift).
Essential
RESPONSIBILITIES:
Deliver Medical Device CE Marking technical reviews under MDD and MDR
requirements, scheme management and ISO **Apply on the website** QMS
assessment services.
Provide advice and support on certifications in area of expertise that
may have a regulatory challenge.
Participate in client meetings to facilitate CE marking processes.
Provide Medical Device expertise leadership and mentoring in areas of
competence to medical devices personnel.
Provide ?Technical Sales/Networking? support as needed
The ideal candidate will possess the following characteristics:
Bachelor&#**Apply on the website**;s degree or higher in a discipline
relevant to medical device design, manufacture and use, or equivalent
qualification.
At least five (5) years&#**Apply on the website**; post-graduate
experience in the design and development of one or more of the
following devices:
Respiratory, Anesthesia, Urology, Soft Tissue Implants, including the
principles of design control, risk management and performance and/or
clinical evaluation
Ability to lead and manage multiple projects with internal and
external clients.
Knowledge of medical device regulations.
Awareness of certification business processes, the application of
quality management standards, and audits What we offer:
BSI offers a competitive salary, ample annual leave/paid time off, and
other robust benefits depending on country.
Our Excellence Behaviours:
Client-centric, Agile, Collaborative. These three behaviours represent
how we do things at BSI. They help us ensure that BSI is a great place
to work and a highly successful business.
BSI is an Equal Opportunity Employer and we are committed to
diversity.
To protect our candidates and BSI employees during the Covid-**Apply
on the website** outbreak, all interviews will take place remotely.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
