Sr Manufacturing Engineer

Responsibilities

• Manage and/or participate in cross-functional teams to provide daily Manufacturing Engineering support of Automated, Manual assembly processes and project-specific goals.
• Work with manufacturing and quality personnel on a daily basis to review and disposition production defects and provide potential process and/or equipment corrective actions to ensure production schedules and quality expectations are met.
• Provide daily production support to set up, troubleshoot, repair, and monitor automated manufacturing assembly equipment.
• Review manufacturing equipment and processes for improvement potential using statistical data and analysis of equipment condition, then effectively manage change projects.
• Lead process improvement projects related to existing manufacturing processes.
• Prepare IQ, OQ, PQ validation protocols and reports to support implementation of new, existing, and upgrading equipment.
• Support new process development, product quality improvement, and integration projects.
• Maintain excellent communications with Manufacturing, Quality, Maintenance, Safety, Planning, and Metrology departments on an as-needed basis.
• Perform process and equipment root cause investigations utilizing 6M, 5Y root cause investigation tools, and summarize findings, recommendations in CAPA/NCR reports.
• Develop and maintain excellent communications with Manufacturing, Quality, Maintenance, Safety, Planning, and Metrology departments on an as-needed basis.
• Scope and develop capital plans to improve equipment and monitor process Overall Equipment Efficiency (OEE) to provide improvements.

Requirements

• Bachelor's degree in Mechanical Engineering, Electromechanical, Mechatronics, or Electrical/Controls Engineering.
• 3-5 years of relevant experience in manufacturing engineering, with preference given to those with medical device industry experience.
• Experience in equipment IQ, OQ, and PQ and/or process validation.
• Experience with DOE (with Minitab).
• Experience with computer and software validation CSV, SOP development, change control of medical devices, and custom equipment validation.
• Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
• Knowledge of FDA 21 CFR Part 820, EU 217/745 (EU MDR), ISO 13485, ISO 14971, IEC 60601.

Qualifications

• Strong mechanical aptitude and ability to perform reverse engineering of mechanical fixtures.
• Excellent communication skills with the ability to interact with various departments within the organization.
• Ability to lead and contribute to cross-functional teams.
• Proficiency in Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
• Experience with process validation lifecycle (from process characterization, operational qualification to performance qualification).

Skills

• Computer and software validation CSV
• SOP Development
• Change control of Medical Devices
• Custom equipment validation experience

Benefits

• Flexible schedule
• Competitive salary
• Health insurance
• Employee discounts

Pay

• $70,000 - $90,000 annually

Schedule

• Full-time