Senior Systems Engineer (all genders) (full-time, regular)

BioSpace; Ludwigshafen am Rhein; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Flexible work models

Mentor onboarding

Global network

Career opportunities in international

Zusammenfassung

AbbVie, a global leader in healthcare, seeks a Senior Systems Engineer for its Device and Combination Product Development team in Germany. You will contribute to the development of aesthetic devices and combination products across clinical stages, collaborating with a global team of scientists and engineers.

You will integrate inputs from multiple disciplines to ensure safe, effective product design and robust performance, supporting commercial development programs and regulatory compliance

Qualifikationen

• Bachelor’s or Master’s degree in Engineering, Science, or related discipline with significant experience.
• Proven technical leadership ensuring design and documentation meet safety and regulatory requirements.
• Experience in product development from concept to release for medical devices or combination products, with familiarity with relevant standards.

Aufgaben

• Drive holistic Systems Engineering within Design Controls, focusing on architecture, inputs, traceability, risk management, change control, and DHF.
• Define and manage user needs, requirements, and applicable standards throughout product lifecycle.
• Lead system and use-related risk management, including planning, risk assessments, and DFMEA/DFMEA.
• Coordinate third-party development activities and ensure alignment of Design Control and Quality by Design.
• Collaborate cross-functionally to identify gaps, drive improvements, and standardize methods for efficiency and consistency.
• Plan and coordinate testing activities, resource planning, and process improvements.
• Serve as dedicated systems engineer for projects, owning key deliverables and coordinating stakeholders.

Kenntnisse

Engineering degree

System engineering

Regulatory compliance

Vendor management

Cross-functional collaboration

Ausbildung

Bachelor’s or Master’s in Engineering/Science

Tools

FDA 21 CFR Part 820.30

ISO14971

ISO 13485

EU MDR

Jobbeschreibung

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

People. Passion. Possibilities. Three words that make a world of difference.

More than a job. It's a chance to make a real difference.

Welcome to AbbVie! As part of an international company with 57,000employees worldwide and around 3,500 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!

Together, we break through as Senior Systems Engineer (all genders)

We are looking for a Senior Systems Engineer to join our Device and Combination Product Development team in R&D.You will contribute to the development of exciting new aesthetic devices and therapeutic combination products for various phases of clinical studies and work closely with cross-functional colleagues in operations as programs transition to commercial development.

In this role youre also responsible for integration of inputs and risks from multiple disciplines to ensure robust patient-centric product design and performance. In this role, you will be working with a global team of exceptional scientists, engineers, and leaders on a variety of devices, drug delivery systems from syringes to autoinjectors to complex electromechanical pumps, with a focus on Aesthetic Filler devices. Your expertise and leadership will ensure these systems are safe and effective in meeting their intended use for clinical and commercial development programs.

Make your mark

• Drive the implementation of holistic Systems Engineering principles within the Design Controls process, with a focus on system architecture and integration, Design Inputs, traceability, risk management, change management, and DHF architecture.


• Define and manage user and stakeholder needs, use cases, product requirements, and applicable standards throughout the product development lifecycle.


• Lead system and use-related risk management activities, including risk planning and reporting, system risk assessments, and design and process FMEAs.


• Oversee and integrate third-party development activities and ensure alignment of Design Control and Quality by Design activities.


• Collaborate with cross-functional team members to identify process gaps, recommend and implement improvements, and help standardize methods and ways of working to enhance consistency, efficiency, operational effectiveness, and the development of sustainable business and organizational strategies.


• Collaborate with cross-functional teams to plan and coordinate testing activities, including sample and laboratory resource planning, and drive improvements to processes, methods, and ways of working.


• Serve as the dedicated systems engineer for projects, independently owning key deliverables and coordinating stakeholder input as needed to support successful execution.

Qualifications

This is how you make a difference

• Bachelors degree in Engineering, Science, or a closely related discipline with 7+ years of relevant experience, or a Masters degree with 5+ years of relevant experience.


• Proven ability to provide technical leadership, ensuring system design and documentation comply with applicable safety and regulatory requirements.


• Expertise in product development from initial concept to release to market is desired with direct experience in combination product or medical device development and familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO14971, ISO 13485 and EU MDR preferred.


• Strong Expertise in Systems Engineering principles including user and stakeholder need definition; requirements definition; risk management, product architecture, configuration management, traceability, and change management


• Expertise in DHF management and creating various Design Control documents in compliance with regulations.


• Strong analytical and problem-solving skills, with the ability to resolve key project challenges, make sound decisions, identify risks, and develop appropriate mitigation plans.


• Experience working with third-party vendors, including vendor communication, management, and deliverable acceptance testing; intercultural competence in a global environment.


• Experience with Aesthetic Filler products is preferred.


• Strong written and verbal communication skills, including scientific writing, combined with a self-driven and structured approach to managing priorities and timelines.


• Excellent written and oral communication skills in Englisch as well as in German with the willingness to travel internationally as required (1020%).

What We Offer You

• 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

At 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.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html