Manufacturing Engineer

Manufacturing Engineer (Zelienople, PA)

Our client in medical devices currently is hiring two Contract to Hire Manufacturing Engineers- additions to staff in order to lead manufacturing improvement projects, develop and validate equipment and processes, create work instructions, manage risks and changes, and ensure production meets safety, quality, and regulatory requirements. The right candidates will be groomed for Direct Hires.

Under the supervision of the Manufacturing Engineering Manager, the Manufacturing Engineer will support manufacturing operations by developing, qualifying, implementing, and maintaining manufacturing equipment, processes, and procedures.

Summary:

Serve as the technical lead for assigned projects, planning, scheduling, organizing, and driving project activities through completion. These roles support cost-saving and continuous-improvement initiatives while helping ensure manufacturing processes meet product requirements, regulatory expectations, quality standards, and company policies.

Key Responsibilities:

Support CTW cost-saving efforts and continuous-improvement initiatives; identify and recommend actionable opportunities.

Serve as the technical lead for assigned projects and drive technical project execution.

Plan, schedule, organize, and coordinate project activities through completion.

Develop assembly and test procedures, written work instructions, and specifications for manufacturing, test, and inspection processes.

Review instructions and procedures with users, incorporate feedback, and update documentation as needed.

Develop, create, and qualify manufacturing and test equipment.

Design and improve processes to optimize flow, reduce variability, increase operating capability, and promote operator safety.

Coordinate with divisional and plant functional groups to evaluate and implement product and process changes.

Communicate change status to relevant functional groups and plant management.

Create and maintain PFMEAs and other risk analyses.

Identify when manufacturing equipment, processes, or support systems require validation to meet product requirements, regulations, quality standards, and company policies.

Lead equipment and process validation and qualification activities, including IQ, OQ, and PQ.

Maintain working knowledge of applicable company policies and procedures, ISO standards, and FDA requirements.

Preferred Qualifications:

Experience in a manufacturing environment within a regulated industry; medical device experience is preferred. All experience levels will be considered.

Experience leading technical projects.

Experience working closely with design engineering, quality engineering, and production personnel.

Knowledge and Skills:

Troubleshooting experience with electromechanical systems.

Ability to read and understand mechanical drawings and electrical schematics.

Strong verbal, written, and interpersonal communication skills.

Strong problem-solving and analytical skills, with attention to detail.

Familiarity with project management methodologies.

Familiarity with FDA regulatory requirements, GMP, ISO, Lean, process validation, and Six Sigma methodologies.

This is a chance to take ownership of meaningful manufacturing projects and improve the processes, equipment, and work instructions that support safe, high-quality medical device production. The roles are contract-to-hire, with the opportunity to be considered for direct hire, and candidates at all experience levels are welcome. The team is aiming for a start before Christmas, with a stretch goal of starting before Thanksgiving, and plans to move quickly with one virtual interview before making a hiring decision.

10444235