Job Summary

With minimum supervision from direct supervisor, performs a variety of engineering assignments to meet quality standards in the most cost efficient manner. May supervise and provide technical assistance to exempt and non-exempt personnel. Will work closely with production and quality departments and have manufacturing engineering responsibility for products at production level. Also will have the responsibility to qualify equipment or processes. Responsible for the approval of procedures change request and qualifications documents. Many projects are broad in nature, the employee uses discretion to design project tasks to bring project to completion and work effectively with cross-functional teams.

Job Details/Responsibilities

• Daily support to manufacturing activities to meet established goals.
• Accountable for the equipment maintenance, setups & troubleshoot.
• Responsible to provide necessary information to maintain appropriate spare parts inventory and evaluation of replacements for obsolete components. Report equipment downtime and scrap per unit metrics.
• Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions. Work with finance to define project costs and financial analysis.
• Responsible for writing, executing and approving equipment/process qualifications. Also, responsible for writing and approving change requests.
• Perform investigations of equipment and process issues to identify root cause, implement controls to eliminate causes, and assess the effectiveness of the controls.
• Ensure compliance with all Company procedures and all applicable regulatory agency requirements.
• Other duties as assigned.

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• • Knowledge of FDA, GMP, and ISO guidelines is required.
  • Strong statistical techniques knowledge (DOE, SPC) is required.
  • Strong computer software knowledge (Microsoft Word, Excel, Power Point).
  • Knows concepts, practices, and procedures of a particular field of specialization.
  • Effective communication and presentation skills.
  • Fully Bilingual (English and Spanish).
  • Willing to travel and work under pressure.

Qualifications/ Background Experiences

• • BS in Engineering, master degree is a plus.
  • Minimum 7 years of experience in a related engineering role (preferably in the medical device industry).
  • PE license is a plus.

Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.