Process Engineer

Job Description

Avery Dennison Medical is seeking a Process Engineer to work with internal customers to find opportunities for process, product, safety, environmental, and facility improvements at our manufacturing location in Northeast Ohio. This role will support daily product and process operations, and provide engineering and technical expertise to production facilities in order to improve plant safety and efficiency, decrease scrap, improve quality, and support new product development.

• Use lean principles to successfully complete projects.
• Support and/or lead the improvements of existing products and the scale-up of new products.
• Lead and participate in capital and process improvement projects. Responsible for all engineering aspects: process, equipment, controls, timelines and collaboration with vendors.
• Perform and participate in risk analysis activities (FMEA, PSSR, MOC, etc.) as the need arises to support project work.
• Lead and conduct problem-solving efforts and propose resolutions.
• Understand and ensure compliance with cGMP, ISO 13485, and FDA CFR 21 Part 820 regulations.
• Support validation process as appropriate.
• Assist in investigation of customer complaints and non-conformances as the need arises.
• Present information and effectively connect with divisions and multi-functional partners.
• Perform other tasks as assigned.

Qualifications

• Bachelors of Science degree in an engineering discipline (mechanical, chemical, biomedical, or electrical).
• 2-3 years experience in highly regulated industry setting and sophisticated training in engineering and project management.
• Knowledge of facilities, systems, and infrastructure within an industrial setting.
• Excellent verbal and written communication skills.
• Empathic, effective in giving/receiving feedback.
• Great teammate, able to coordinate efforts across functions, plants, and divisions. Strong project management skills and ability to run multiple concurrent priorities.
• Experience with statistical analysis, statistical process controls (SPC and DOE).
• Ability to resolve root cause and corrective/preventive actions with problem solving techniques such as FMEA, fishbone diagram, 5 whys, etc.
• Strong PC skills – MS Office, MINITAB, etc.
• Be flexible in work hours to support a 24/5 operation as needed.

• Member of PMI, ISPE, ASME, or AICHE and EIT, PE, CAPM, PMP, or LEED certification.
• Familiar with medical device regulations and industry guides such as: CFRs, ISO, ICH, and GAMP,
• Experience with AB ladder logic and AutoCAD experience.
• Web handling experience.
• Green Belt / Black Belt certification.
• Project management experience.

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Additional Information

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status or other protected status. EEOE/M/F/Vet/Disabled. All your information will be kept confidential according to EEO guidelines.