Process Engineer

Job Highlights

Company Profile

STERIS advances global health and safety with innovative products and services for procedures, medical devices, vaccines, and life sciences.

Job Profile

The company is seeking a Process Engineer who will be responsible for establishing manufacturing process capability for new/reformulated/sustained products and supporting the execution of equipment qualification, cleaning, and process validation programs.

Prepare and revise batch records, operating instructions, and cleaning instructions, and conduct process improvement studies in the areas of operational productivity, process control, quality processing, employee safety, process yield improvement, and environmental impact in a lean environment.

Test new technologies, processes, controls, or prototype equipment and support implementation as appropriate to optimize liquid blending systems while providing indirect supervision of technicians, interns, and operators as required.

Education Level

• Bachelor’s Degree in Mechanical Engineering (BS) from an accredited four-year college or university

Work Experience

• 2-5 years of experience in process/industrial engineering, production support, or design transfer.

Duties/Responsibilities

• Collaborate with Operations and CI to identify needs and opportunities for improvement.
• Collaborate with quality for specific manufacturing processes through troubleshooting and implementation of corrective actions.
• Kaizen and lean events. SWI creation, revision, and validation. OPS projects that deal with process and fixture creation, modification, and improvements. Tools and fixtures documentation and modification.
• Maintain a safe working environment by fully implementing the World Class safety initiatives and culture of STERIS Corporation and enforcing these initiatives at all times.
• Monitor and provide solutions in terms of quality, yields, throughput, cycle times, process parameters, compliance, and safety and environmental requirements.
• Provide personnel training, development of manufacturing instructions, and start-up of new processes/equipment. IQ/OQ/PQ support.
• Responsible for conducting process studies, identifying opportunities for improvement, and supporting implementation of findings to optimize manufacturing processes.
• Responsible for research and testing of new technologies or processes appropriate for the support of new/existing product manufacturing. Complex process creation and maintenance (laser welding, etching).
• V&V process standardization (V&V transfer and test procedure standardization).

Skills/Knowledge/Abilities

• 3D CAD and mechanical drafting (SolidWorks).
• Familiarity with QMS, and familiarity with FDA (ISO 13485)/local regulations
• Project leadership skills, Lean/CI technical skills, and organizational skills are required
• Value stream and Process mapping.

Work Environment

• Fixture and tooling design
• Solid Technical writing
• Understanding of design for assembly.
• Working within a manufacturing environment

Benefits/Perks

• 401(k) with a company match
• Additional add-on benefits/discounts
• Continued training and educational programs
• Excellent healthcare, dental, and vision benefits
• Extensive Paid Time Off and added Holidays.
• Long/Short-term disability coverage
• Parental Leave

Employer’s Statement

STERIS is an Equal Opportunity Employer.