Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with new product development procedures.
Project manage the introduction of new products and processes 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.
Develop and model product costing in collaboration with Finance teams.
Develop and track project timelines, deliverables, and hold team accountable for meeting deadlines.
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.
Minimum Qualifications
Bachelor's degree in an engineering discipline
Around 4-6 of experience in a technical role and project leading activities
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.
Highly organized individual that can track simple to mid-complexity projects and set team priorities
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 (Medical device preferred)
Experience with International Manufacturing preferred
High level of PC Skills required (MS Project, Visio, PPT, Word)
Excellent attention to detail
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