- Execute assigned project elements with an emphasis on manufacturing systems and procedures required for the manufacture of new products.
- Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Company new product development procedures.
- Project manage the introduction of new capital equipment and support the associated qualification and validation activities.
- Evaluate process layouts in terms of supporting new process integration while ensuring best utilization of floor space ensuring optimum process flow.
- Ensure quality of process and product as defined in the appropriate operation and material specifications.
- Will assist in the selection of components and equipment based on analysis of specifications, reliability and regulatory requirements.
- Support capital acquisition activities.
- Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
- Conduct MSA studies for new products and new processes.
- Provide training for manufacturing team members.
- Ensure adherence to GMP and safety procedures.
- All other duties as assigned
- B.S in Mechanical Engineering or related engineering discipline with with 2 or more years’ experience.
- Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
- The individual should enjoy working in a fast paced, dynamic and results orientated team environment.
- Strong communication skills with the ability to effectively work cross-functionally and externally as required.
- Basic knowledge of manufacturing processes, materials, product and process design.
- Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
- Experience in an FDA regulated or regulated industry beneficial.
- High level of PC Skills required. Excellent attention to detail.
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