Manager- Process Engineer

We are seeking a highly skilled and motivated Process Engineer at managerial role to join our team at Morepen Laboratories Ltd, a leading organization dealing in manufacturing of home care diagnostics medical devices. The Process Engineer will play a crucial role in optimizing manufacturing processes, ensuring product quality, and driving continuous improvement initiatives. This role requires a strong understanding of manufacturing principles, medical device regulations, and process improvement methodologies.

Role & responsibilities

• Process Optimization:

* Analyze and optimize manufacturing processes to improve efficiency, reduce costs, and
enhance product quality.

* Develop, implement, and validate process improvements, including new equipment,
procedures, and technologies

• Technical Support:

* Provide technical support to production teams to resolve process issues, equipment
malfunctions, and quality concerns.

* Collaborate with cross-functional teams, including R&D, quality assurance, and
production, to ensure smooth integration of new products and processes.

• Compliance and Documentation:

* Ensure all processes comply with regulatory requirements, including FDA, ISO 13485,
and other relevant standards.

* Develop and maintain process documentation, including Standard Operating Procedures
(SOPs), Work Instructions, and Process Flow Diagrams.

• Process Development:

* Design and execute process validation studies, including installation qualification (IQ),
operational qualification (OQ), and performance qualification (PQ).

* Identify and implement best practices for process design, control, and monitoring

Preferred candidate profile

Qualifications:

• Education: Bachelors degree in Engineering (Mechanical, Electrical, Industrial, Biomedical, or related field). Advanced degree or certifications (e.g., Six Sigma, Lean) preferred.

• Experience: Minimum of [4-10] years of experience in process engineering and [2-4] years in managerial position within a medical device or regulated manufacturing environment.