Entwicklungsingenieur (m/w/d) Medizintechnik

FERCHAU – Connecting People and Technologies

Mannheim

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AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

The job that makes possibilities real in patients' lives. And yours.

The job that helps you get ahead in life. Moving mountains together.

Welcome to AbbVie! As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!

Moving mountains together – as

Design Verification Engineer – Method Development (all genders) (full-time, permanent)

REF: R00131837

Job Description

We are looking for an experienced Design Verification Engineer – Method Development (all genders) to join our Device and Combination Product Development to contribute to the development of exciting new drug / device combination products.

Your tasks and responsibilities

Subject-Matter Expert (SME) for Test Method Development of delivery devices and combination products: Test Method development, including best practices for universal implementation, Test Method Validation/Transfer.
Design Verification: Author verification protocols and reports. Support investigations and issue resolutions.
Execute test protocols supporting exploratory and verification testing, analyze data, document in lab notebooks, and present results to cross-functional teams. Utilize Zwick Universal Test Machine (UTM) and other GMP and non-GMP test equipment used for combination product development and Design Verification.
Software Tools: Utilize Electronic Lab Notebook (ELN) software and electronic DHF tools such as Polarian.
Implementing process automation and digitalization initiatives to enhance efficiency and reliability in device development and manufacturing processes.
Utilizing analytical modelling for key performance attributes and ensuring compliance with regulatory requirements, including FDA, EMA, and ISO standards.

Qualifications

Bachelor Degree or equivalent education with typically 7 or more years of experience or Master Degree or equivalent education with typically 5 or more years of experience. 5+ years of experience in medical devices or combination products.
Proficiency and knowledge in the design and testing of injection devices and combination products.
Comprehensive background in operating and maintaining material testing equipment
Strong communication skills (both written and verbal) including the ability to influence without direct authority.
Knowledge of ICH and ISO Guidelines, GMP, Design Controls, GDP, and FDA regulations.
Documentation experience including technical reports, design verification plans, protocols, etc.
Strong understanding of engineering fundamentals with strong problem-solving and analytical skills.
A keen eye for identifying project risks and proactively developing mitigation plans.
Self-driver with proven track record of actively engaging and working in a matrixed environment with cross-functional teams, strong decision-making, and completing quality deliverables on time.

Here's how we can move mountains together

With a diverse work environment where you can have a real impact
With an open corporate culture
With an attractive salary
With an intensive onboarding process with a mentor at your side
With flexible work models for a healthy work-life balance
With a corporate health management that offers comprehensive health and exercise programs
With company social benefits
With a wide range of career opportunities in an international organization
With top-tier, attractive development opportunities
With a strong international network

Multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

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AbbVie Deutschland GmbH & Co. KG

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