Product Lifecycle Manager - Medical Device (m/w/d)

Coloplast; Nieder-Olm; Vor Ort; EUR 70.000 - 100.000; Vollzeit

Benefits dieser Stelle

Mobile working

Professional development

Zusammenfassung

Atos Medical in Nieder-Olm, Germany, seeks a Product Lifecycle Manager – Medical Devices to ensure regulatory compliant, safe, and future-proof device portfolios across their lifecycle. You’ll manage design control, maintain technical documentation, and balance regulatory, quality, and business needs while collaborating with R&D, Quality, Regulatory Affairs, and Operations.

The role requires a bachelor’s degree in a technical field, 3+ years in medical devices or life sciences, and proficiency

Qualifikationen

• Bachelor's degree in a technical or scientific field (engineering, medical technology, pharmaceutical sciences, biotechnology, life sciences or comparable).
• At least 3 years of experience in the medical device or life-science industry, ideally in lifecycle management or quality-regulated functions.
• Experience managing complex, cross-functional projects with multiple stakeholders.
• Practical experience in regulated environments (EN ISO 13485, EU-MDR, 21 CFR 820, MDSAP, ISO 14971, IEC 62366).
• Fluent English (C1) and German (B1)
• MS Office 365 proficiency.
• Analytical, structured, solution-oriented mindset.

Aufgaben

• Managing product and design changes across the lifecycle with regulatory-compliant documentation.
• Maintaining Design History Files and technical documentation for devices of class Is to IIa/b.
• Ensuring traceability from user needs to design inputs/outputs and validation.
• Acting as technical contact for Design Control and Lifecycle Management.
• Contributing to quality activities such as risk management, CAPAs, complaints, and post-market topics.
• Supporting transfer of new developments into production.
• Participating in design reviews as an independent reviewer.

Kenntnisse

Regulatory compliance

Lifecycle management

Project management

Quality management

English (C1)

Ausbildung

Bachelor in engineering

Master's degree advantageous

Tools

MS Office 365

Jobbeschreibung

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Product Lifecycle Manager - Medical Device (m/w/d)

Location: Nieder-Olm, DE

Job Family: Marketing

Country/Region: Germany

EN - Job Advertisement

We are a medium-sized, fast-growing company with around 300 employees in the medical device industry, headquartered in Nieder-Olm near Mainz. Due to our high level of expertise, we are a national market leader in our field and continue to experience steady growth in the international market. Flat hierarchies, short communication channels, innovative strength, and open doors characterize our company culture.

At the earliest possible date, we are looking for a candidate for our Nieder-Olm site as

Product Lifecycle Manager – Medical Devices (m/f/d)

Scope of position: Full-time, 40 hours per week / 1.0 FTE Type of employment: Fixed-term employment due to parental leave Location: TRACOE medical GmbH, 55268 Nieder-Olm / Germany

Our role – your mission

As a Product Lifecycle Manager, you ensure that our medical device portfolio remains regulatory compliant, safe, and future-proof throughout its entire lifecycle. You manage design and change processes, keep our technical documentation up to date, and balance regulatory, quality, and business requirements. In doing so, you work closely with R&D, Quality, Regulatory Affairs, and Operations.

Your tasks and responsibilities

• Managing product and design changes throughout the entire lifecycle - including project management and the creation of regulatory-compliant documentation (EN ISO 13485, EU-MDR, 21 CFR 820, MDSAP)
• Maintaining and further developing the Design History Files (DHF) as well as the technical documentation for medical devices of classes Is/m to IIa/b
• Ensuring complete traceability from user needs to design inputs/outputs through to verification, validation, and risk management
• Acting as the technical point of contact for Design Control & Lifecycle Management for all relevant stakeholders
• Contributing to quality-related activities such as risk management (EN ISO 14971), CAPAs, complaints, non-conformances, and post-market topics
• Planning and supporting the transfer of new developments and product changes into production
• Participating in design reviews as an independent reviewer with a focus on lifecycle and compliance aspects
• Supporting audits and inspections as well as actively contributing to the continuous improvement of our lifecycle management processes

Your profile

• Completed bachelor’s degree in a technical or scientific field (e.g., engineering, medical technology, pharmaceutical sciences, biotechnology, life sciences or comparable), master’s degree is an advantage
• Required: At least 3 years of experience in the medical device or life-science industry, ideally in product lifecycle management or in quality-regulated functions
• Proven experience in managing complex, cross-functional projects with multiple stakeholders - preferably in a change-control or lifecycle context
• Practical experience in a regulated environment (EN ISO 13485, EU-MDR, 21 CFR 820, MDSAP, ISO 14971, IEC 62366) and experience working within a quality management system is desirable
• Required language skills: English at least C1, German at least B1
• Confident use of MS Office 365
• Strong quality mindset and the ability to pragmatically implement technical, regulatory, and documentation-related requirements
• Experience working in an international environment
• Analytical, structured, and solution-oriented working style
• High level of initiative, sense of responsibility, and reliability
• Holistic thinking and openness to new perspectives

Why us – our offer

• A secure and responsible position within a successful and international team
• A welcoming culture and structured onboarding
• A friendly working atmosphere and colleagues who meet you at eye level
• Idea management, room to shape processes, and independent work
• Active support for your professional and personal development through internal and external training opportunities
• Flexible working time models, flexitime, and the option for mobile working (up to 2 days per week)
• Company events, free parking, and much more

Product Lifecycle Manager - Medical Device (m/w/d)

Founded in 1986, Atos Medical is the global leader in laryngectomy care as well as a leading developer and manufacturer of tracheostomy products. We are passionate about making life easier for people living with a neck stoma, and we achieve this by providing personalized care and innovative solutions through our brands Provox®, Provox Life™ and Tracoe.

We know that great customer experience involves more than first-rate product development, which is why clinical research and education of both professionals and patients are integral parts of our business.

Our roots are Swedish but today we are a global organization made up of about 1400 dedicated employees and our products are distributed to more than 90 countries. As we continue to grow, we remain committed to our purpose of improving the lives of people living with a neck stoma.

Since 2021, Atos Medical is the Voice and Respiratory Care division of Coloplast A/S