R&D Manager

At Röchling Medical, we're united by a shared purpose: improving lives through innovation in health. As a trusted partner to leading pharmaceutical, biotech, and medical device companies around the world, we develop customized products and solutions that help advance patient care and save lives. Your roleMust be authorized to work in the US. Sponsorship not available.ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following. Other duties may be assigned.Leads, coaches, and develops R&D engineers and technical staff.Lead execution of internal and customer development projects from feasibility through design transfer, ensuring technical quality, documentation completeness, and adherence to timelines and scope.Serve as the primary technical interface for clients, managing expectations, communicating risks, and maintaining alignment with contractual obligations, quality agreements, and service level commitments.Direct technology transfer and scale up activities, including development of transfer protocols, acceptance criteria, and cross functional readiness with Engineering, Quality, Operations, Safety, Health & Environmental.Oversee supplier and subcontractor qualification, performance monitoring, and compliance with supplier quality agreements.Support regulatory submissions by providing technical documentation, verification/validation data, risk analyses, and responses to regulatory inquiries.Prepare for and host customer, regulatory, and internal audits; ensure timely closure of findings and robust corrective actions.Ensure compliance with applicable standards and regulations (e.g., ISO 13485, 21 CFR 820, GMP), including data integrity, design control, and documentation requirements.Lead risk management activities (e.g., DFMEA), ensuring proactive identification, mitigation, and escalation of technical and program risks.Develop and execute verification, validation, and process validation strategies (IQ/OQ/PQ), including protocol authorship, execution oversight, and approval.Collaborate with Quality and Operations to define product release criteria, support nonconformance investigations, and drive CAPA activities.Manage project budgets, cost to complete forecasts, and change order processes in partnership with Program Management and Finance.Provide leadership to teams, cross functional and matrixed teams, fostering collaboration across multiple sites and external partners.Build internal capability through training, knowledge transfer, and development of best practices for CDMO project execution.Protect client intellectual property and ensure secure handling of confidential information throughout the development lifecycle.REQUIRED SKILLS AND ABILITIESDemonstrated supervisory experience, including coaching, workload management, and performance development of technical staff.Ability to build and develop high-performing teams across matrixed and multi-site environments.Skilled in mentoring engineers and fostering technical growth aligned with organizational priorities.Strong project execution and prioritization skills; ability to translate direction into structured plans.Solid understanding of regulated development environments and cross-functional collaboration with Quality/RA and Operations.Strong communication skills and stakeholder management across functions and cultures.Pragmatic problem solving, structured root-cause thinking, and decision-making under constraints.Willingness and ability to travel regionally/internationally as required.Adhere to the Quality System Regulations FDA CFR 820 and ISO 13485.EDUCATION and/or EXPERIENCEBachelor's degree in Engineering (Mechanical, Biomedical, Materials, Polymer, Industrial, or related field) or equivalent practical experience.Ten (10) or more years of demonstrated experience in medical device development within a CDMO, OEM, or regulated manufacturing environment. Experience with metal machining & plastic injection molding preferred.Strong understanding of design controls, risk management, verification/validation, and GMP manufacturing principles.Experience with technology transfer, scale up, and process validation for medical devicesFamiliarity with regulatory pathways (e.g., 510(k), PMA, CE Mark) and associated documentation requirements.Proven ability to lead cross functional teams and manage client facing technical programs.SUPERVISORY RESPONSIBILITIES Supervises 1 to 6 individuals.LANGUAGE SKILLSFluent in English; additional languages are a plus. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, employees, clients, customers, and the general public.KEY PERFORMANCE INDICTATORS (KPIs)On-time delivery of project milestones and design-control deliverables.Successful technology transfer and scale-up outcomes, measured by first-pass yield, readiness, and manufacturing acceptance.Audit performance, including number of findings, closure timeliness, and recurrence rate.Budget adherence and accuracy of cost-to-complete forecasting.Customer satisfaction scores and repeat business indicators.CAPA effectiveness and closure timelines.Quality of technical documentation, including completeness, accuracy, and regulatory readiness.Supplier performance metrics (e.g., qualification status, audit outcomes, on-time delivery of components/services).WORK ENVIRONMENTThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the essential functions of the job, the employee is required to work in a sedentary office environment. The employee may also be regularly exposed to moving mechanical parts. The employee is frequently exposed to vibration. The noise level in the work environment is usually moderate.QUALIFICATIONSTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.This job description is intended to describe the essential job duties and requirements for the performance of this job. It is not intended as an exhaustive statement of all duties that may be assigned or required.Your benefitsHealth Management: Your health and well-being are important to us. Take advantage of our diverse health offerings, such as the health clinic.Training and Development: Our focus is on the continuous growth of our team members. We want to ensure that everyone can reach their full potential, which is why we offer tailored training programs for various roles. This helps you achieve peak performance and boosts your professional success!Food: Our sites offer vending machines with a variety of snacks and food options for you to enjoy - perfect for added flexibility during shift work, ensuring convenient access to refreshments at any time.Flexibility: Flexibility leads to efficiency - that's what we believe. That's why mobile work is possible.

Created: 2026-04-02