Senior R&D Engineer

Envista Holdings Corporation; Nordrhein-Westfalen; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Envista's Nobel Biocare division in North Rhine-Westphalia seeks a Senior R&D Engineer 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.

The role requires cross-functional collaboration, risk management, and guidance for junior engineers, spanning design controls, V&V, regulatory compliance, and innovation within the Envista ecosystem.

Qualifikationen

• Bachelor's or Master's in Engineering; extensive medical device development experience.
• Knowledge of Design Controls, ISO 13485, ISO 14971, EU MDR, FDA regulations, V&V, systems engineering.
• Strong project management and teamwork skills; compliant and pragmatic.
• Fluent in German and English, written and spoken.
• Experience in Quality management within regulated medical devices.

Aufgaben

• Lead product development and provide technical direction.
• Make design decisions and drive technical strategy.
• Perform design verification and validation activities.
• Lead risk management efforts and maintain risk registers.
• Ensure regulatory compliance across applicable standards.
• Collaborate across functions to deliver programs.
• Drive innovation activities and process improvements.
• Mentor junior engineers and build capability.
• Evaluate field performance and reliability data (trend reporting).
• Align budgets and forecasts within the QMS context.
• Promote Envista Business System (EBS) usage.
• Prepare budget and adjust forecasts and accruals as needed.

Kenntnisse

Leadership

Cross-functional collaboration

Project management

German/English fluency

Design Controls

Regulatory knowledge

V&V

Systems engineering

CAD

Risk management

Ausbildung

Bachelor's or Master's in Engineering

PhD research project (pre-requisite)

Tools

CAD

QMS

V&V tools

Jobbeschreibung

Germany, North Rhine-Westphalia, Herzogenrath

Full time

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

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Operating Company:

Nobel Biocare

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 .