R&D Hardware Engineer - Medical Devices

Agilent Technologies

Glostrup, Denmark

Job Description

We are seeking a R&D Engineer for our System Lifecycle Support team which is part of Pathology R&D in our Diagnostics and Genomics Group. We want to strengthen our System Lifecycle engineering activities to ensure efficient and successful progress in new sustaining projects and maintenance of our high-quality portfolio of pathology stainer instruments for cancer diagnostics. We are maintaining existing products on the market as well as contributing to developing our future instruments. We therefore need the best in class Medical Device Engineer to ensure effective diagnostic solutions valued by our customers.

The team responsibilities include:

Instrument improvements projects/activities e.g. feature enhancements and design optimizations based on customer feedbacks;
Instrument product care/sustaining activities;
Instrument design transfer projects (development and in-sourcing);
Design Control and design documentation.

The job and your responsibilities:

As R&D Engineer you will work with the team to drive activities and projects related to our instrument portfolio.

You provide expert inputs during manufacturing issues, customer complaint handling, improvement projects etc. Your input has direct impact on our ability to deliver to the market, on user safety and fulfillment of requirements set up by the regulatory authorities.

To succeed, you collaborate with a broad range of stakeholders in the organization e.g. Marketing, Procurement, Regulatory Affairs, Quality Assurance, Manufacturing and Global Service.

Your tasks will include:

Plan and execute on sustain activities;
Analysis of complaints with unknown root cause;
Securing good hardware design, serviceability and manufacturability during instrument enhancement projects;
Ensuring that our marketed instruments are in compliance with regulatory requirements;
Plan testing and test execution as part of verification;
Documentation according to internal and regulatory requirements.

Qualifications

You most probably have a background as Mechanical or Electrical Engineer with experience in engineering design, product development and sustaining/maintenance;
You have experience with design and manufacturing of metal and plastic parts and good knowledge on how to obtain robust product designs through product development;
You have experience with design controls incl. requirements engineering, design verification, change control, product risk management and documentation, with medical devices;
You have experience from a regulated environment – Medical Devices or Pharma;
In addition, you are preferably skilled in and have experience with robust engineering design and root cause analysi;
You will work in an international environment, hence solid skills in English (both written and spoken) are a must.

On a personal level you must be good at driving your activities while communicating and coordinating with various stakeholders within the organization. You are dedicated and driven by results, which you reach by working closely with your colleagues within the team, as well as the rest of the organization.

You are well-structured and have a systematic way of working, seeking simple and effective solutions within the complexity that surrounds a medical device and the accompanying documentation package. You can work with day-to-day deadlines and changing priorities, as well as in projects with longer duration.

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