Quality Control and Medical Device Certification Researcher

Job Title: Quality Control and Medical Device Certification Researcher

Job Ref: AICOS_Jobs_2022_08

Job Type: Full-time contract (1 year - renewable)

Job Salary: Depending on the candidate's academic degree and professional experience.

Job Location: Aveiro, Portugal.

 

Job Description and Responsibilities:

The candidate will perform research activities within the Connected Things (Cyber-physical systems) group, namely in the area of Quality Assurance & Regulatory Pre-Compliance and, more specifically, quality control and medical device certification procedures.

The candidate will integrate a team dedicated to testing software, firmware and hardware of products that undergo medical device certification procedures and ensuring the pre-compliance of such devices before the certification itself.

The candidate will work on the following tasks:

- Definition and development of a quality management system to assure pre-compliance of a medical device with relevant standards and regulations;

- Document quality policies and manuals, as well as all mandatory procedures and records to assure compliance with quality management system standards, such as ISO13485:2016;

- Conduct internal audits of processes in execution in the scope of projects that undergo pre-compliance procedures.

 

Personal Skills:

Candidates with experience in implementing a quality management system based on ISO 13485:2016 and a risk management system based on ISO 14971:2019 are preferred. The candidate will help the team to ensure EU MDR 2017/745 compliance, so knowledge or experience within this field will be highly valued. Candidates with knowledge or experience in complying with Software as Medical Device development standards, such as IEC 62304:2006 (Software life cycle processes), are favoured. Additionally, knowledge or experience with compliance with other common medical device development standards will be valued, such as IEC 62366-1:2015 (Application of usability engineering).

Previous working experience in relevant areas will be highly regarded. The candidate must be able to work both autonomously and within a dynamic development team. The candidate must show excellent English communication skills.

 

Academic Qualifications:

Academic Master's degree or equivalent academic qualifications (or equivalent second cycle complete) in the area of Informatics Engineering, Electrical Engineering, Computer Science, Bioengineering, Biomedical Sciences, or similar.

 

Other Skills:

- Experience with medical devices certification procedures;

- Knowledge of medical device-related norms and standards;

- Proficiency in English, both spoken and written.

 

Professional Experience:

Three to five years of professional experience or research experience in R&D projects related to medical device certification.

 

What we offer:

- Excellent work conditions;

- Being part of the team of one of the most renowned applied R&D institutions in the world;

- Adequate salary (depending on the academic degree and professional experience);

- Private health insurance plan.

 

Application Process:

Applications are permanently open until the ideal candidate is selected. A first “cut-off” to evaluate applications day will occur on the 19th August 2022.

The selected candidate is expected to start working in September 2022.

Applications must be made to the email jobs@fraunhofer.pt and contain:

- CV – mandatory;

- Motivation Letter – mandatory;

- Recommendation Letters are optional but also welcome.

 

Observation:

The research activities in the scope of this job opportunity are planned to be developed within the framework of projects:

- ConnectedHealth – Smart and End-to-end Healthcare Management Platform, with reference POCI-01-0247-FEDER-046858, Funded by Norte 2020 Programa Operacional Regional do Norte.

- SmartHealthNetwork, with reference NORTE-02-0853-FEDER-037641

- SmartHealth4All, with reference POCI-01-0247-FEDER-046115, Funded by Norte 2020 Programa Operacional Regional do Norte.