Associate Manufacturing Engineer

BD - Zelienople, PA

Full-time - Entry Level

Zelienople, PA

5,001-10,000 employees

Miscellaneous Manufacturing

About the position

We are the makers of possible. BD is one of the largest global medical technology companies in the world, and our purpose is to advance the world of health. This mission requires the imagination and passion of all our team members—from design and engineering to manufacturing and marketing of our billions of MedTech products each year. We believe that the human element across our global teams is what allows us to continually evolve. Join us and discover an environment where you will be supported to learn, grow, and become your best self. As a Manufacturing Engineer, you will work under the supervision of the Manufacturing Engineering Manager and be responsible for supporting manufacturing by developing, qualifying, implementing, and maintaining manufacturing equipment, processes, and procedures. In this role, you will lead the sustaining engineering effort for assigned product lines, coordinating with divisional and plant functional groups to evaluate and implement changes to products and processes. You will communicate the status of these changes to functional groups and plant management, ensuring that specifications and procedures for manufacturing, testing, and inspection processes are developed and maintained. Your responsibilities will also include designing and developing processes to optimize flow, reduce variability, improve operating capabilities, and ensure operator safety. You will identify the need for validation of manufacturing equipment and processes, leading the validation and qualification efforts (IQ, OQ & PQ) and updating PFMEA/Risk analysis as necessary. This position is dynamic, and duties may change at any time to support the business needs.

Responsibilities

• Lead the sustaining engineering effort for product line(s) as assigned.
• Coordinate with divisional and plant functional groups to evaluate and implement changes to products & processes.
• Communicate status of changes to functional groups as well as plant management.
• Develop and maintain specifications and procedures for manufacturing, test and inspection processes.
• Design and develop processes to optimize process flow, reduce variability, improve operating capabilities, and ensure operator safety.
• Identify need for validation of manufacturing equipment/process and support systems to meet product requirements, regulations, quality and company policies.
• Lead the validation/qualification effort for equipment and processes (IQ, OQ & PQ).
• Update PFMEA/Risk analysis as necessary.

Requirements

• Bachelor's degree in an engineering discipline.
• Excellent communication (verbal & written) and interpersonal skills.
• Ability to read and understand mechanical drawings and electrical schematics.
• Experience working closely with design engineering, quality engineering and production personnel.
• Familiarity with FDA regulatory requirements, GMP, ISO, lean, process validation and six sigma methodologies.
• Good logic and reasoning ability to define problems and find logical solutions.
• Ability to evaluate and resolve daily issues by exercising sound judgement.

Nice-to-haves

• Experience with troubleshooting electromechanical systems.
• Experience in a manufacturing environment in a regulated industry (medical device preferred).
• Fixture design experience.
• Lean manufacturing process design.
• Equipment validation experience.

Benefits

• A career at BD means being part of a team that values your opinions and contributions.
• Encouragement to bring your authentic self to work.
• A culture in which you can learn, grow, and thrive.