Every day, Getinge Group enables healthcare professionals to save lives. Based on first-hand experience and close partnerships, we provide innovative healthcare solutions to support before, during and after the patients’ hospital stay. Our company is built on a genuine compassion for people’s health and well-being. We approach our work with passion. In addition, our culture and behavior are guided by collaboration, openness, ownership and excellence – values we believe are the key to our success. Being part of Getinge Group means being an ambassador for these values and contributing to making a difference in peoples’ lives.

Getinge Group is in an exciting and intensive period of change and we are strengthening our Business Category Unit Acute Care Therapies (ACT) and manufacturing site in Solna with a Material Specialist. You will be part of the Mechanical design team. The position offers you the opportunity to work cross-functional, locally as well as globally, together with a winning team. You will be taking part in developing world class med-tech products in a challenging regulatory environment with high ambitions within a fast-paced manufacturing organization!

The position

The primary purpose as a Material Specialist is to create biocompatibility evaluations and reports in connection to release of new ventilation and anesthesia products or modified existing products.You will work closely with the mechanical engineers, the QA/RA department, the Development project department, the Market/After-market department and the Customer complaints department.

Among your main responsibilities and tasks will be:

• Choose materials together with mechanical engineers based on mechanical performance and exposure at use.

• Responsibility of verification activities regarding exposure environment (e.g. cleaning, sterilization, exposure to breathing gas and anesthesia, and exposure to stomach acid).

• Responsibility of biological evaluation plans, including biological hazard identification, risk assessment and identification of complementary tests.

• Set up test specifications and communicate needs with test houses.

• Evaluate results from biological tests and chemical analyses including toxicological evaluations of detected substances.

• Write biological evaluation reports to be sent to notified body and agencies with jurisdictions.

• Perform material failure analyses.

• Support handling of REACH and RoHS related issues.

The position is located in Solna and international travels may be required occasionally, approximately 1-2 travels per year. The position will be reporting to the Manager of Mechanical Design in Solna.

The ideal candidate

The person we are looking for has 5-15 years of experience from a similar position or area within the medical device industry today.

We believe that your key characteristics include:

• Experience of biological safety evaluations of medical devices, alternatively exposures and risk evaluations of chemical substances.

• Knowledge of polymer materials and their compositions, or organic chemistry, or biochemistry.

• Knowledge within Analytical chemistry, chemical characterization methods and their limits.

• Experience in FDA regulated environment.

• MSc, or PhD, in Polymer Chemistry, Organic Chemistry or similar.

• Fluent in our corporate language English, both written and spoken, is required as well as proficiency in Swedish for the daily work.

As a person you are a goal-oriented and cooperative team-player who drives results and takes responsibility. You have a structured personality and an analytical mindset with the ability to multitask and meet deadlines. Being able to communicate efficiently with different stakehold

Timmar per vecka: Heltid Tills vidare

Arbetsgivare Namn: Getinge Group AB

Arbetsgivare adress: P.O Box 8861 40272 Göteborg

Form av kontakt:
titel : telefon 1: () telefon 2: () mobil: e-post:

Jobb kort beskrivning: Industrial and production engineers

Land: Sweden

Område: Stockholms län

Avtalstid: Permanent

Typ av kontrakt: Full time

Källa till jobberbjudande: Public Employment Service of Sweden(AMS)

Hur man ansöker: Other - see free text