R&D Engineer
Job in
1013 ML, Amsterdam, North Holland, Netherlands
Listed on 2026-06-18
Listing for:
Get 360Pharma
Full Time
position Listed on 2026-06-18
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Process Engineer
Job Description & How to Apply Below
Purpose Driving activities related to the design and development of innovative intraocular lenses (IOLs) for the Research & Development team. Apply advanced skills of the field to construct industry leading products. Contribute to scientific projects and processes under general direction.
You will be responsible for:
Analyze product and process requirements (materials, quality, EHS) and perform risk and root cause analysis.
Develop and improve product designs, processes, equipment, test methods, and procedures; define technical requirements.
Plan and execute validation and verification studies, including test plans, protocols, data analysis, and issue resolution.
Implement new or modified products and processes, author SOPs, protocols, risk assessments, and train employees.
Participate in project planning, design reviews, and gate reviews; report progress and close projects per effectiveness checks.
Maintain compliance with cGMP, ISO standards; update procedures, support audits, and resolve CAPAs/NCRs.
Collaborate with Operations, QA, and Manufacturing Engineering to support implementation and design transfer.
Qualifications / Requirements Bachelor’s degree in Engineering or related field;
Master’s preferred.
Minimum 2–4 years in product and process development within a regulated industry (medical device or pharma).
Hands‑on experience with validation, verification, and compliance activities (cGMP, ISO).
Strong analytical and problem‑solving skills; familiarity with risk analysis and root cause methodologies.
Proficient in the use of Microsoft Office (Word, Excel) and Microsoft Teams.
Proficient in applying statistical methodologies and analysis using Minitab.
Verbal and written proficiency (at least at B2 level) in English.
Preferred specific knowledge and skills Analysis of datasets using Python or Mat Lab.
Designing 3D models using Solid Works.
Experience in rapid prototyping techniques using 3D printing.
Proficient in the use of Microsoft Project.
Verbal and written proficiency in Dutch.
Six Sigma Certified Green Belt / Black Belt.
Knowledge in high precision machining (lathing and milling).
Knowledge in high precision injection molding.
Required Skills Collaborating
Critical Thinking
Cross‑Functional Collaboration
Preferred Skills Analytical Reasoning
Computerized Equipment Skills
Data Reporting
Emerging Technologies
Engineering
Execution Focus
Gemba Kaizen
Mechanical Equipment
Process Control
Process Oriented
Product Improvements
Purchasing
Quality Standards
Research and Development
SAP Product Lifecycle Management
Situational Awareness
Teamwork
Technical Research
Technologically Savvy
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