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 developmentTechnical decision-makingDesign Verification and ValidationRisk managementRegulatory complianceCross-functional collaborationInnovation activitiesMentoring of junior engineers.Evaluate field performance and reliability data (Trend Reporting)Financial scope is defined in the budgetDetailed responsibilities are defined in the QMSModeling Circle values and promoting the use of EBS tools.Preparing budget and adjusting forecasts and accruals as neededJob 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 pragmaticAbility to work cross-functionallyAgility to learn and to adapt individual and team performance to company standards and expectationsFluent in German and English, both in conversation as well as in writingPosition requires a seasoned R&D professional with the potential for further personal developmentRelevant 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-PG1Operating Company:Nobel BiocareEnvista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.SummaryLocation: Germany, North Rhine-Westphalia, HerzogenrathType: Full time
Senior R&D Engineer
