Advanced Process Manufacturing Engineer

Steris Corporation•Mentor, OH

11d•Onsite

About The Position

Provide Engineering/Manufacturing technical expertise in support of the total operations functions, goals, objectives, and projects of the STERIS Endoscopy division of STERIS. Responsible for establishing and maintaining manufacturing processes and procedures, including capacity planning, tooling, process development, routings, cost reductions, and quality improvements. Helps give technical expertise to Engineering teams through mentorship, acting as a reviewer, and aiding in the guidance of strategic initiatives. Some travel is required, estimated at 2 or 3 weeks per year.

Requirements

Bachelor of Science degree required in Engineering or related technical field.
Minimum of 10 years of manufacturing engineering experience.
Minimum of 7 years’ experience in medical device manufacturing or equivalent field.
Lean manufacturing experience required; Six Sigma experience is a plus.
Understanding of the medical device regulatory, document, and quality control issues.
Proficiency in AutoCAD, SolidWorks, or equivalent drawing program.
Familiarity with 3-D Programming & Analysis Package required—SolidWorks preferred.
Strong interpersonal skills and verbal and written communication skills.
Ability to lead and facilitate cross functional teams.
MiniTab experience is a plus.
Experience with toos such as SPC, PFMEA, and IQ/OQ/PQ Required.
Supplier audit experience is preferred.

Nice To Haves

Six Sigma experience is a plus.
MiniTab experience is a plus.
Supplier audit experience is preferred.

Responsibilities

Support all Company Quality Policies including ISO 13485, MDD, and FDA.
Develops methods, standards, procedures, plans, processes, programs, and schedules to meet operational needs.
Designs tooling, current products, fixturing, facilities and systems.
Maintains the integrity of the above listing based on changing requirements and needs.
Identifies and analyzes engineering related problems and/or opportunities.
Determines and implements economical solutions to problems and opportunities which consistently continue to meet our customers’ needs and requirements.
Conducts cost analysis, cost justification, and feasibility studies for product and process changes including investigation of innovative technologies.
Performs training of operators and other personnel, as needed.
Participates in cost reduction programs.
Ensures operations and practices conform to safety regulations.
Coordinate tests to verify performance and/or conformance to manufacturing standards.
Audits/maintains systems to ensure integrity of Company and customer quality standards and requirements.
Effectively evaluates and own commination with new vendors. Give guidance to peers and customers on current and future manufacturing capabilities.
When needed, act as representative for operations in audit settings.
Give feedback on division level decisions and initiatives.
Lead smaller teams of Engineers or manufacturing personnel to support department goals and enhance manufacturing experience competency.