Principal R&D Engineer

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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The role of the Principal R&D Engineer is responsible for designing and developing new or revised medical devices, pharmaceutical products, and biological processes, taking into consideration problems inherent in the transfer of technology from research to manufacturing. Develop product manufacturing procedures for economical mass production in cooperation with pilot line and production departments. Leads and executes projects following the Design Control regulations for medical devices. Conducts tests and measurements throughout stages of development and production to determine control over applicable variables. Troubleshoots, and solves product and production process problems with existing and novel processes or equipment already in operation. Prepares and maintains reports to ensure product testing and processes are compliant and follow regulations.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

About Vision

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Johnson & Johnson Vision (MedTech) is recruiting for a Principal R&D Engineer , located in Groningen, The Netherlands. The engineer will be responsible for R&D activities related to the design and development of innovative intraocular lenses (IOLs).

You will be responsible for:

• Develop, improve and characterize products, processes, equipment, test methods and procedures and define requirements

• Lead in planning and execution of development projects, project design reviews (Design Control) and project gate reviews and close projects with predefined effectiveness checks.

• Lead engineering, validation and verification studies by setting up a test plan and protocol, test criteria, performing tests, analyzing, interpreting and reporting outcomes as well as identifying and solving technical issues.

• Plan, coordinate and evaluate the implementation of new or modified products and processes, including the creation of protocols, reports and procedures, risk assessments and performing training of employees.

• Analyze and assess product and process requirements (materials, process, quality, EHS, product specifications) and perform risk and root cause analysis

• Present results and progress of projects and activities in project meetings, partners and management meetings.

• Provide support following implementation of process and product changes, work closely together with other departments, including Operations, Quality Assurance, Manufacturing Engineering, Marketing and Regulatory Affairs as appropriate.

• Work according to assigned procedures to ensure compliance, rigorously applying current good manufacturing principles (cGMP), Design Control and applicable industry standards (ISO, ANSI) within the field of medical devices.

• Keep up with (changes in) relevant procedures and regulation, adjust, develop and maintain procedures, assist in internal and external audits. Resolve CAPA’s (corrective and preventive actions) and NCR’s (non-conformance reports).

Qualifications / Requirements:

• Master of Science or Engineering in relevant subject is preferred with minimal 6 years of professional experience in a highly regulated industry like medical device or Pharma.

• Bachelor of Science or Engineering in relevant subject with minimal 8 years of professional experience in a highly regulated industry like medical device or Pharma.

• Experienced in leading multidisciplinary projects or complex projects with significant business impact.

• Demonstrated knowledge in problem-solving methodology (DOE, Process Capability Analysis, Hypothesis Test Methods).

• Proficient in applying statistical methodologies and analysis using Minitab.

• Excellent verbal and written proficiency (at least at B2 level) in English, Dutch knowledge will represent an advantage.

Preferred specific knowledge and skills:

• Knowledge of process validation and/or systems validation.

• Proficient in the use of Microsoft Project.

• Analysis of complex datasets using Python or MatLab.

• Knowledge of high precision injection molding technology.

• Experience in rapid prototyping techniques using 3D printing.

• Designing 3D models using SolidWorks.

• Six Sigma Certified Green Belt / Black Belt.

• Knowledge in high precision machining (lathing and milling).