Senior Systems Engineer ALM (fmd)

Baxter; München; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

Ein international tätiges Medizintechnikunternehmen in München sucht einen Senior Systems Engineer (m/w/d), der die Entwicklung innovativer medizinischer Geräte vorantreibt. Die Rolle umfasst die technische Leitung in Projekten, Systemanalysen sowie die Weiterentwicklung von ALM-Prozessen in Polarion. Bewerber sollten über mehrere Jahre Erfahrung in der Produktentwicklung und mit ALM-Tools verfügen. Das Unternehmen bietet ein dynamisches Arbeitsumfeld sowie ein attraktives Vergütungspaket.

Leistungen

Überdurchschnittliche Sozialleistungen

30 Tage Urlaub plus Sonderurlaub

Firmenrentenprogramm

Qualifikationen

• Abgeschlossenes Studium oder vergleichbare Ausbildung in relevanten Bereichen.
• Mehrere Jahre Erfahrung in der Arbeit mit ALM-Tools, vorzugsweise Polarion.
• Erfahrung in der Produktentwicklung im Medizinsektor ist von Vorteil.
• Zertifizierung in Systems Engineering, z. B. CSEP, ist von Vorteil.

Aufgaben

• Leitung technischer Entwicklungen in Projekten und Unterstützung des Design-Teams.
• Durchführung von Systemanalysen und Pflege technischer Dokumentationen.
• Entwicklung und Pflege von Prozessen im ALM-Tool Polarion.

Kenntnisse

Laboratory Experience

Vendor Management

Design Controls

C / C++

FDA Regulations

Intellectual Property Law

ISO 13485

Research Experience

SolidWorks

Research & Development

Internet Of Things

Product Development

Ausbildung

Studium der Systemtechnik, Medizintechnik, Softwaretechnik oder vergleichbares

Tools

Polarion

Jobbeschreibung

This is where your work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

Join Our Team: Senior Systems Engineer ALM (f / m / d) Opportunity in Munich or Saalfeld

We are seeking an experienced Senior Systems Engineer to strengthen our team in Munich Bavaria or Saalfeld Thuringia. As a key member of our team you will play a vital role in driving the development of innovative medical devices and contributing to the success of our organization by improving processes and workflows in our ALM tool Polarion.

You take over technical leadership in development projects providing guidance and expertise to the design team. You are the technical owner and decision-maker for owned products.

Key Responsibilities

System Analysis and Requirements Management

• Conduct thorough system and requirements analysis to ensure the development of high-quality medical devices
• Collaborate with cross-functional stakeholders to gather analyze and document requirements
• Manage requirements effectively to ensure alignment with project goals and objectives

Technical Documentation and Risk Management

• Prepare technical documentation for medical devices ensuring compliance with regulatory requirements
• Execute risk management and FMEAS to mitigate potential product risks and ensure patient and user safety

System Integration and Verification Support

• Lead system integration efforts to ensure seamless integration of components and subsystems
• Support verification and validation to ensure accuracy and reliability

ALM Process Development

• Develop and maintain processes and workflows in Polarion to support medical product development including requirements management risk management and V&V.
• Collaborate with stakeholders to identify and prioritize process improvements in Polarion.
• Design and control the implementation via external service provider s of custom workflows and integrations in Polarion to meet the needs of our medical product development teams.
• Provide training and support to teams on the use of Polarion and its associated processes.

Your Profile

Education and Experience

• Completed studies in systems engineering medical technology software engineering information technology or a comparable degree program or comparable training
• Several years of experience in working with ALM tools preferably Polarion
• Several years of product development in the medical devices sector or other regulated environment is a plus
• Systems Engineering certification like CSEP is a plus

Language Skills

• Good written and spoken German and English skills

Personal Qualities

• Self-reliant structured independent and solution-oriented work
• Excellent teamwork and communication skills

Why Join Our Team

• Opportunity to work on innovative medical devices and contribute to the success of our organization
• Collaborative and dynamic work environment
• Professional development and growth opportunities

Competitive compensation and benefits package

What we offer you

As an internationally active company we offer you professional training opportunities and fair remuneration with above-average social benefits a company pension scheme a share plan for employees 30 days vacation plus special leave and additional insurance is a matter of course for us.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability / handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and / or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.

Required Experience

Senior IC

Key Skills

• Laboratory Experience
• Vendor Management
• Design Controls
• C / C++
• FDA Regulations
• Intellectual Property Law
• ISO 13485
• Research Experience
• SolidWorks
• Research & Development
• Internet Of Things
• Product Development

Employment Type: Full-Time

Experience: years

Vacancy: 1