Lediga jobb Brainlink AB i Göteborg

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MedTech Quality Assurance / Regulatory Affairs (QA/RA) specialist

Brainlink is looking for a Quality Assurance / Regulatory Affairs (QA/RA) specialist About Brainlink Brainlink AB is a Swedish medical technology startup sprung from the inside perspective of neurosurgery. Our core focus is to integrate today’s technology into existing treatments that globally affect more than a miilion patients yearly. We aim to create breakthrough medical devices for more effective diagnostics and treatment of neurological conditions, ... Visa mer
Brainlink is looking for a Quality Assurance / Regulatory Affairs (QA/RA) specialist

About Brainlink
Brainlink AB is a Swedish medical technology startup sprung from the inside perspective of neurosurgery. Our core focus is to integrate today’s technology into existing treatments that globally affect more than a miilion patients yearly. We aim to create breakthrough medical devices for more effective diagnostics and treatment of neurological conditions, while saving resources for hospitals and healthcare staff worldwide.
Who are we looking for
We are looking for a Quality Assurance / Regulatory Affairs (QA/RA) specialist with a passion to transform healthcare through assisting in solving complex design problems. In this role you will work together with our team of engineers and management, taking on activities related to all areas of the product development cycle. You have excellent organizational and project management skills.
Background
As QA/RA specialist, you will participate in key cross functional activities in support of medical device development. In this role you are expected to be readily available and flexible to support a broad range of technical needs of the company.


In this role, your responsibilities will include:
? Developing and sustaining Brainlink's Quality Management System for Regulatory Compliance.
? Participate in activities related to ideation, valuation, testing and verification of product development.
? Work collaboratively with the engineering and management team.
? Communicate effectively within the team as well as with external touchpoints.
? Support in keeping the timeline of delegated internal and external tasks, report progress and status through weekly updates.
? Application of standards and standard operating procedures for the product development.

Required qualifications
? University degree (MSc or equivalent) in engineering or biomedicine.
? Minimum 2 years experience in QA / RA in medtech product development.
? Experience in medtech product development.

Recommended qualifications
? Experience in regulatory assurance for medical implants.
? Experience in medical technology development.
? Experience working with sensor systems and/or wireless signaling in a medical environment.

Brainlink offers you
? Use your experience to improve healthcare outcomes and make a real difference to patients around the world.
? Participate in creating a new paradigm within MedTech.
? The opportunity to work at arm’s length from clinical medicine.
? A work experience that is challenging and rewarding, with space for independent thinking, innovation, and growth.


Salary: To be discussed
Employment conditions: Full- or part time (minimum 50%)
Location: On site: Gothenburg, Sweden. Candidates preferably currently based in Gothenburg, but we do welcome applications from citizens located outside Sweden.
EU Visa is mandatory.
Öppen för alla
Vi fokuserar på din kompetens, inte dina övriga förutsättningar. Vi är öppna för att anpassa rollen eller arbetsplatsen efter dina behov. Visa mindre

Design Engineer for medtech startup

Brainlink is looking for a Design Engineer About Brainlink Brainlink AB is a Swedish medical technology startup sprung from the inside perspective of neurosurgery. Our core focus is to integrate today’s technology into existing treatments that globally affect more than 900 000 patients yearly. We aim to create breakthrough medical devices for more effective diagnostics and treatment of neurological conditions, while saving resources for hospitals and hea... Visa mer
Brainlink is looking for a Design Engineer

About Brainlink
Brainlink AB is a Swedish medical technology startup sprung from the inside perspective of neurosurgery. Our core focus is to integrate today’s technology into existing treatments that globally affect more than 900 000 patients yearly. We aim to create breakthrough medical devices for more effective diagnostics and treatment of neurological conditions, while saving resources for hospitals and healthcare staff worldwide.

Brainlink is an early-stage start-up, but our knowledge derives from extensive hands-on clinical experience within neurosurgery. We are just at the beginning of our journey and now Brainlink is looking for innovative team players to take on key roles for the continuation of our path forward!

Who are we looking for
We are looking for a Design Engineer with a passion to transform healthcare through assisting in solving complex design problems. In this role you will work closely with our Senior Design Engineer, taking on activities related to all areas of the product development cycle. You have excellent organizational and project management skills.

Background
As Design Engineer, you will participate in key cross functional activities in support of medical device development. In this role you are expected to be readily available and flexible to support a broad range of technical needs of the company.

In this role, your responsibilities will include:
? Participate in activities related to ideation, valuation, testing and verification of product development.
? Work collaboratively with management, regulatory, quality, and manufacturing to assist in defining device design and development objectives.
? Support the process of technical documentation according to EU MDR and FDA regulations.
? Communicate effectively within the team as well as with external touchpoints.
? Support in keeping the timeline of delegated internal and external tasks, report progress and status through weekly updates.
? Application of standard engineering techniques and procedures regarding product development.

Required qualifications
? Mechanical or Electronic Engineering degree or related field.
? Minimum 1 year experience in Design Engineering or Product Development.
? Experience in concept development, prototyping, testing and verification.


Recommended qualifications
? Experience in developing implants for medical use.
? Experience in medical technology development.
? Experience working with sensor systems and/or wireless signaling in a medical environment.
? Good knowledge in materials and material selection.
? PhD within relevant field.

Brainlink offers you
? Use your experience to improve healthcare outcomes and make a real difference to patients around the world.
? Participate in creating a new paradigm within MedTech.
? The opportunity to work at arm’s length from clinical medicine.
? A work experience that is challenging and rewarding, with space for independent thinking, innovation, and growth.


Salary: To be discussed
Employment conditions: Full- or part time (minimum 50%)
Location: On site: Gothenburg, Sweden. Candidates preferably currently based in Gothenburg, but we do welcome applications from citizens located outside Sweden.
EU Visa is mandatory.
Öppen för alla
Vi fokuserar på din kompetens, inte dina övriga förutsättningar. Vi är öppna för att anpassa rollen eller arbetsplatsen efter dina behov. Visa mindre

Senior Design Engineer for medtech startup

Ansök    Maj 28    Brainlink AB    Medicinteknisk ingenjör
About Brainlink Brainlink AB is a Swedish medical technology startup sprung from the inside perspective of neurosurgery. Our core focus is to integrate today’s technology into existing treatments that globally affect more than 900 000 patients yearly. We aim to create breakthrough medical devices for more effective diagnostics and treatment of neurological conditions, while saving resources for hospitals and healthcare staff worldwide. Brainlink is an ea... Visa mer
About Brainlink
Brainlink AB is a Swedish medical technology startup sprung from the inside perspective of neurosurgery. Our core focus is to integrate today’s technology into existing treatments that globally affect more than 900 000 patients yearly. We aim to create breakthrough medical devices for more effective diagnostics and treatment of neurological conditions, while saving resources for hospitals and healthcare staff worldwide.

Brainlink is an early-stage start-up, but our knowledge derives from extensive hands-on clinical experience within neurosurgery. We are just at the beginning of our journey and now Brainlink is looking for innovative team players to take on key roles for the continuation of our path forward!

Who are we looking for
We are looking for a senior design engineer with a passion to transform healthcare through solving complex design problems. This position requires that you can work independently, while building networks and leading different teams. You are excellent at acquiring new skills and sharing your knowledge. You drive the project forward by taking ownership of your deliveries and by keeping the momentum in collaboration with external partners.

Background
As Senior Design Engineer, you will take the technical lead and be the main driver of the development of a new medical device.

In this role, your responsibilities will include:
? Provide leadership in all areas of the product development cycle.
? Be responsible for product development workshops and testing according to industry standards.
? Collaborate with external partners regarding R&D and regulatory compliance while maintaining QMS best practice.
? Support the process of technical documentation according to EU MDR and FDA regulations.
? Manage and follow-up internal and external tasks, report progress and status through weekly updates.
? Communicate effectively across all functions within the team as well as with external touchpoints.

Required qualifications
? Mechanical or Electronic Engineering degree or related field.
? Minimum 5 years of experience in Senior Design Engineering or Senior Product Development roles.
? Experience in medical technology development.
? Experience in concept development, prototyping, testing and verification.

Recommended qualifications
? Experience in developing implants for medical use.
? Experience in working with sensor systems and/or wireless signaling in a medical environment.
? Good knowledge in materials and material selection.
? PhD within relevant field.

Brainlink offers you
? Use your experience to improve healthcare outcomes and make a real difference to patients around the world.
? Participate in creating a new paradigm within MedTech.
? The opportunity to work at arm’s length from clinical medicine.
? A work experience that is challenging and rewarding, with space for independent thinking, innovation, and growth.

Salary: To be discussed
Employment conditions: Full- or part time (minimum 50%)
Location: On site: Gothenburg, Sweden. Candidates preferably currently based in Gothenburg, but we do welcome applications from citizens located outside Sweden. EU Visa is mandatory.
Öppen för alla
Vi fokuserar på din kompetens, inte dina övriga förutsättningar. Vi är öppna för att anpassa rollen eller arbetsplatsen efter dina behov. Visa mindre