Assists in optimization of current processes, and development of new processes in support of R&D, Manufacturing and Product Development.
Provides support and guidance on validation activities related to manufacturing/test equipment and processes.
The process engineer will conduct a gap analysis of existing sealing equipment and Establish/Document a validated test method and qualified sealing equipment to ensure reliable seal strength measurements in compliance with ISO 11607 and ASTM standards.
Requirements:
Bachelor's degree in engineering or equivalent work experience. Minimum of 3 (three) years direct process engineering experience in medical device industry. Good analytical and problem-solving skills.
Excellent written and verbal communication skills with good presentation and technical writing skills.
Collaborative attitude with the ability to work well in a team environment.
Strong engineering, design, and analysis skills.
Working knowledge of tooling and manufacturing processes.
Experience with medical devices from concept to commercialization.
Experience qualifying sealing equipment through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to validate its performance within the defined operating ranges.
Understanding of FDA Quality Systems Regulations.
Skills :
Accurate Ability to perform work accurately and thoroughly.
Communication (Written /Oral) Ability to communicate effectively in written and oral form.
Excellent report writing skills essential.
Problem Solving Ability to find a solution or deal proactively with work related problems.
Interpersonal Ability to develop and sustain positive relationships with internal as well as external customers.
Advanced computer skills including MS Office applications (Word/Excel) and Minitab statistical analysis software are required.
Knowledge of statistical techniques and sampling for process validation and process monitoring desired.
Experience with Agile PLM or other documentation management system desired.
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