Title:  Sr. Engineering Specialist

Job Summary

In this fully onsite position you will be responsible for supporting execution of new projects and continuous improvement activities for manufacturing and support equipment.  Support manufacturing through the implementation of projects to continually improve existing facilities, equipment or processes. Execute on implementation of long-term corrective actions to meet or exceed internal and external standards and regulations. Provide high-level troubleshooting assistance to maintenance personnel for complex equipment issues.

Essential Duties and Responsibilities

• Under guidance and leadership, work with internal and external teams to:

• • Scope project requirements in support of new equipment and process optimization development projects.
  • Collaborate on creation of user and equipment requirements.
  • Support development, execution and documentation of project assignments in compliance with committed timelines and project goals, and per established governance policies and procedures.
  • Execute facility Strategic Plan related to equipment replacements or upgrades

• Provide engineering assistance to keep production equipment operating at an optimum efficiency.
• Evaluate existing equipment and facility systems, looking for methods to improve performance, efficiency, reliability or accuracy and present recommendations for same.
• Analyze problem areas with existing equipment and prepare design changes or recommend component replacement as required to resolve problems.
• Assist in mechanical, pneumatic, hydraulic, and electrical design modifications of equipment.
• Assist with preparation and execution of all necessary validations and/or engineering evaluations as needed for manufacturing equipment.
• Support equipment improvements for safety and reliability, cost reductions/savings, scrap reductions, quality improvements etc. through the implementation of LEAN concepts.
• Create/modify work instructions, technical documents, engineering studies, and non-conformance reports as needed to support production.
• Maintain clear communication paths with stakeholders, providing routine project review updates as needed.
• Impacts quality of own work and the work of others on the team; works within guidelines and policies.
• Performs other duties as assigned based on business needs.

Education

• Bachelor’s degree in Engineering or related schooling and work experience may be substituted for Engineering degree required    

Work Experience

• Minimum 5 years Progressive maintenance and leadership experience may be substituted for educational requirements. required and
• Experience with FDA regulations in relation to Facilities, Maintenance and Equipment repair required and
• Experience in managing projects required and
• Experience with automation systems required

Preferred Knowledge, Skills and Abilities

• Medical device development and manufacturing background 
• Experience in plastic injection and or medical device manufacturing 
• Experienced in qualification/validation writing and execution
• Knowledge of manufacturing processes, workflows, and industrial techniques
• Background in PLC’s and related systems – AB, Siemens, Mitsubishi
• Understanding of industrial utility systems – electrical, water, pneumatics, etc
• Experienced in equipment level diagnostics and repairs
• Must have effective problem solving and interpersonal skills
• Must have knowledge of sound engineering principles and practice
• Must possess the ability to plan work and supervise others, as needed

License and Certifications

• Certification in one or more of the key building trades. preferred

Travel Requirements

Physical Requirements