Senior R&D Engineer

Envista Holdings Corporation; Herzogenrath; Vor Ort; EUR 80.000 - 105.000; Vollzeit

Zusammenfassung

Envista is seeking a Senior R&D Engineer in Germany to lead design, development, verification, validation and lifecycle management of medical devices. You will provide technical leadership and ensure compliance with regulatory and quality requirements, coordinating with cross-functional teams.

The role requires strong knowledge of Design Controls, ISO 13485, ISO 14971, EU MDR and FDA regulations, with fluent German and English and a track record in medical device development.

Qualifikationen

• Degree in engineering; several years in medical device development.
• PhD research experience is a plus.
• In-depth knowledge of standards/regulations: Design Controls, ISO 13485, ISO 14971, EU MDR, FDA, V&V, systems engineering, CAD, risk management.

Aufgaben

• Lead product development and technical decision-making.
• Perform design verification and validation and manage risk.
• Ensure regulatory compliance and collaborate cross-functionally.

Kenntnisse

German fluency

English fluency

Regulatory knowledge

Project management

Cross-functional teamwork

Ausbildung

Bachelor’s or Master’s in Engineering

PhD preferred

Tools

CAD

V&V

Risk management

Jobbeschreibung

Job Description

The Senior R&D Engineer leads the design, development, verification, validation, and lifecycle management of medical devices, providing technical leadership and ensuring compliance with regulatory and quality requirements. This function include the following relevant tasks:

• Lead product development
• Technical decision-making
• Design Verification and Validation
• Risk management
• Regulatory compliance
• Cross-functional collaboration
• Innovation activities
• Mentoring of junior engineers.

Evaluate field performance and reliability data (Trend Reporting) Financial scope is defined in the budget

Detailed responsibilities are defined in the QMS

Modeling Circle values and promoting the use of EBS tools. Preparing budget and adjusting forecasts and accruals as needed

Job Requirements

• Bachelor's or Master's degree in Engineering or related field; typically multiple years of experience in medical device development.
• Completed PhD research project is a pre.
• In depth knowledge on standards and regulation including but not limited to: Design Controls, ISO 13485, ISO 14971, EU MDR, FDA regulations, V&V, systems engineering, CAD, risk management, etc.
• Project management competence and experience, ability to work in a team.
• Consequent and efficient, compliant and pragmatic Ability to work cross-functionally Agility to learn and to adapt individual and team performance to company standards and expectations
• Fluent in German and English, both in conversation as well as in writing
• Position requires a seasoned R&D professional with the potential for further personal development
• Relevant experience in Quality management and the regulated medical devices environment Experience in interacting with other departments, from cross-functional work and a basic understanding from all functions in the company #LI-PG1

Operating Company

Nobel Biocare Envista and its family of companies (Envista)

Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.