Senior Device Engineer

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Job Description

OBJECTIVES/PURPOSE

Pharmaceutical Sciences (PharmSci) organization is an integral part of global R&D at Takeda translating science into therapeutic products for patients. When you join PharmSci, you become a part of a team dedicated to bringing our products to life for our patients through innovation, dedication and talent.

As a Device Engineer IV in the Device Drug Qualification & Compatibility team, a part of Drug Product and Device Development within Pharmaceutical Science, you will be responsible for evaluating different medical devices for several commercial products for EU and Rest Of the World (ROW). You will also support biological in-use studies with subvisible particle measurements and characterization. You will report to the Head of Device Drug Qualification & Compatibility VIENNA.

Your Opportunity:

• Investigate costumer device complaints (reconstitution devices, injection pens, needle safety devices and autoinjectors) of commercial products from EU and Rest of the World (ROW)

• Support mechanical/functional testing during in-use studies related to insertion, aspiration and expel forces

• Support device related biological in-use studies with characterization testing

• Use several equipment such as optical stereomicroscope, caliper, depth micrometer, ultrasonic cutter, digital camera, force measurement device and subvisible particle equipment (e.g. MFI, Flowcam) according to SOP or guidance documents

• Work closely with Market Surveillance (MS), Commercial Device Engineers (CDE) and Device Quality Assurance (DQA) during complaint investigations

• Be involved in device related in-use testing for clinical phase I to III and lifecycle management activities

Accountabilities:

• Independently collects and manages data and interpret data using existing standard procedures, digital platforms and software tools

• Identifies and communicates routine technical problems

• Investigate device complaints, draft and finalize investigation reports under Good Documentations Practices (finalize record in our “Trackwise” system)

• Independently interprets and communicates results to MS, DQA and/or CDE

• Decontaminate used devices if needed, before sending to external laboratories

• Coordinate with an external laboratories for vendor testing

• Arrange shipments of medical devices if required for further evaluations to the respective manufacturers, e.g. US, Taiwan, Canada, Germany, etc.

• Technical resource for junior colleagues and may mentor them

• Support mechanical and biological device related studies

• Support and/or execute method validations for mechanical/functional testing

• Support and/or execute method qualification studies and development experiments

Your Skills and Qualifications:

• Has a basic understanding on medical devices related to different offered forms of the drug (lyophilized, liquid) and administration routes (IV, SC, ...) with all pros and cons during handling these medical devices

• Ability to work independently with minimal supervision

• Strong attention to detail

• Team and result oriented, organizational ability

• Good communication skills when working with cross functional teams (MS, CDE and DQA)

• Profound knowledge in polymer/plastics processing and assembly is desirable

• Familiarity with device design control, design manufacturing and medical device development

• Excellent analytical and problem-solving skills

• Good written and oral communications skills in English required, German desirable

• Basic knowledge of Statistics

• Time and resource management

• Associates degree and 7+ years relevant industry experience OR Bachelors degree and 5+ years relevant industry experience OR Masters degree and 3+ years relevant industry experience,  

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work – life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer.

We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.

Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is €3909 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.

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