Johnson & Johnson
Senior R and D Process Engineering
Senior R&D Process Engineering
Working on several projects and products with the focus on the new product: lenses
Location: Groningen, the Netherlands (remote work negotiable, desirable at least 1/week on a site)
Paygrade Level: 25
Working hours: 32-40/week
The contract for 9 months (extension offer per performance)
- Contractor: 25-30 eur/h
- Freelancer: (own payroll): 62-66 eur/h
· Contributes to the manufacturing readiness activities as a team member of the NPI development projects.
· Contributes to planning and execution of engineering activities to ensure manufacturing process readiness for transfer NPI products.
· Works closely with R&D Engineering Subject Matter Experts to effectively define strategies and execute in compliance with Design Control Procedures.
· Conducts hands-on process development and engineering using strong experiment and statistical analysis techniques.
· Takes ownership in executing product and process development strategies.
· Authors and review protocols and technical reports under Design Control for NPIs.
· Partner with cross-functional team members to define the impact of regulatory requirements and medical device industry trends/practices.
- Process validation experience
- Understanding ISO regulations (medical devices: 13485, 11979…)
- Executing end-to-end processes
- Preparing documents, understanding regulatory requirements, data analytics, protocols, reposts
- Reviewing and approving documents from other engineers
· SAP knowledge very desirable
· Tools: SAP, MiniTab, Agile
· Statistical experience
· Pharma, medical devices, ophthalmology experience highly desirable
· Experience with statistical design and analysis of experiments.
· Working knowledge of process development.
· Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, Physics or another science discipline.
· 3 years in a similar role, being previous experience in the medical device industry highly preferred.
· Strong communication, organizational, and interpersonal skills.