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)

Pay rate:

-       Contractor: 25-30 eur/h

OR

-       Freelancer: (own payroll): 62-66 eur/h

Key Responsibilities:

·       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

Required:

·       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.  

Other:

·       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.