For our client, a Medical Device company, we are currently loking for a Process Development Engineer to reinforce its Product Process Development Team.
Process Development Engineer (m/w - 100%)
Work within product development team to develop manufacturing process for new products or processes :
- Define by data analysis or DOE optimized process parameters influencing product properties and then define recipes for processes such as but not limited to sterilization.
- Define heat treatment processes (part of sterilization cycle) allowing to guarantee product properties.
- Define strategy and execute initial validations of the special processes (sterilization)
- Development of manufacturing processes and scale-ups
- Define process parameters
- Define predictive models on process parameters to reach product performances
- Execute process development project tasks are accomplished within defined timelines, procedures, objectives, budget and required safety/compliance standards
- Research, develop and evaluate materials, processes and/or equipment
- Conduct feasibility studies to verify capability and functionality
- Participation on communication with notified body or agency?s
- Participation on assessments to evaluate processes changes or deviation on product performances
- Write and execute test procedures and SOPs
- Maintain complete and thorough documentation in accordance with required US and international standards (e.g., ISO compliance, GLP/GMP/QSR requirements, etc.) for assigned projects.
- Write and perform Validation plan strategy and process validations in collaboration with Validation team including methods for inspection.
- Manage and control Risk process analysis and appropriate recommendations to mitigate the risk.
- Engineering degree or equivalent. Combination of education and experience will be considered
- Trained to ISO 17665 - Knowledge of moist-heat sterilization
- Knowledge of ISO 13485 and GMP
- At least 4-5 years confirmed experience in product development activities and project management in a regulated field
- At least 4-5 years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation
- Industrial experience working in a GMP compliant setting
- Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Statistical design of experiments, process flow diagrams, device design controls, process simulation and other engineering software, etc. are preferred.
- Team player motivated by success of the company, goal-oriented, excellent communication skills, both written and oral
- Experience with regulatory filings for Medical Devices and supporting regulatory inspections
- English and French speaking
Have we piqued your interest? We look forward to receiving your application!