The Mechanical/Design Engineer is responsible for leading moderately complex projects to support OEE within Finishing Manufacturing. Specifies and develops new manufacturing equipment and/or design improvements to existing equipment, and employs automation where feasible and practical. Able to coach/train junior Engineers and technicians on the engineering process and design theory.  This position will be able to be an active participant/leader of URS development, vendor selection, and design reviews for new equipment and sub-systems from 3rd party automation vendors. This Engineer may lead smaller teams of junior Engineers, either directly, or indirectly.

This position will sit in Rochester, NY.

The Responsibilities

• Lead/participate in current machine OEE improvements.

• Support large capital projects by participating in design reviews, suggesting improvements, leading working sessions, and providing feedback to the project manager.

• Develop URS documents for automated equipment.

• Support Maintenance and Technicians with troubleshooting of mechanical issues on current automated equipment.

• Ensure compliance with FDA and cGMP for self, team, and vendors.

• Carry out duties in compliance with all local, state, and federal regulatory bodies including FDA, EPA, OSHA, DEP and DEA.

• Perform other work-related duties as assigned.

Required:

• BS in mechanical engineering or other related discipline with 5-7 years of work experience or MS with at least 3 years of experience.

• Minimum 5 years of experience in an automated manufacturing support or automation build role.

• Strong electrical & mechanical aptitude with troubleshooting experience.

• Adept with MicroSoft Office tools (e.g. Word, Excel, Project, PowerPoint, etc.)

• Ability to manage competing priorities in a results-driven environment.

• Ability to lead teams and meet project deadlines.

• Ability to travel 30% overall, with periods of up to 80%.  Some international travel is expected.

Preferred:

• Experience working in an FDA Medical Device Manufacturing Facility with associated FDA and ISO regulations.

• Direct experience with motor drive systems, process controls systems, manufacturing equipment and vision systems.

The Key Working Relationships:

• Internal Partners: Capital Equipment Project Manager, Staff Mechanical Design Engineer, Quality Engineering, Validation group, Line Engineering
• External Partners: Automation Vendors, Suppliers