Senior NPI Automation Engineer

job summary:
Our client is seeking a Senior NPI Automation Engineer to serve as a Subject Matter Expert (SME) in high-speed automated assembly and test systems for medical device manufacturing. Acting as the critical technical and project management bridge between customer product designs, global engineering teams, and third-party automation vendors, you will hold complete responsibility for custom automation execution. In this high-impact role, you will author User Requirement Specifications (URS), create preliminary layouts, lead equipment quoting, evaluate part designs for automated assembly compatibility (DFM), and direct off-site builds, IQ/OQ/PQ validation, and seamless line transfers into global production sites on schedule.

This role requires approximately 50% travel and is offered as a 100% remote position. Candidates must be based in the Eastern or Southeastern United States.

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location: Atlanta, Georgia
job type: Contract
salary: $65 - 72 per hour
work hours: 8am to 4pm
education: Bachelors

responsibilities:

• Lead vendor evaluation and selection for custom automation equipment with Global Procurement. Drive vendor design reviews, off-site builds, FAT, and SAT.

• Act as the primary technical point of contact between external customer design teams, internal manufacturing engineering, and equipment vendors.

• Lead cross-functional teams through global equipment handovers, site launches, technical escalations, and smooth production transfers.

• Author detailed User Requirement Specifications (URS) for high-speed assembly, robotics, vision inspection, motion controls, and automated testing systems.

• Evaluate pre-designed customer products for automated assembly compatibility (DFM/DFA) to maximize throughput, reduce scrap, and optimize OEE.

• Specify equipment, tooling, fixtures, vision systems, and motion controls for new and existing automated lines.

• Author and execute equipment validation protocols (IQ/OQ/PQ) in compliance with FDA 21 CFR Part 820, ISO 13485, and cGMP standards.

• Conduct process risk assessments (FMEA), ensure traceability, and maintain audit-ready documentation for all installed automation.

Qualifications:

• B.S. in Mechanical or Electrical/Electronics Engineering (or equivalent) with 9+ years in high-speed automation design, sourcing, and implementation within medical device manufacturing.

• Demonstrated track record authoring URS documents and managing third-party custom automation integrators from RFQ through SAT.

• Hands-on experience authoring and executing IQ/OQ/PQ protocols for automated equipment in FDA-regulated environments.

• Direct experience serving as a customer-facing technical lead on NPI programs.

Preferred / Plus Qualifications:

• Fluency in both English and Spanish (written and verbal) is highly preferred due to LATAM operations.

• Formal project management training/experience or certifications (e.g., PMP, CAPM) is a plus.

Travel:

• Willingness and ability to travel internationally to manufacturing sites and vendor facilities across the U.S., EU, and LATAM.

qualifications:

• Experience level: Experienced
• Minimum 9 years of experience
• Education: Bachelors

 
skills:

• Automation Anywhere
• Engineering
  
  
  
  
  Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
  At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on us.fitly.work.
  
  
  
  
  Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
  
  
  
  
  This posting is open for thirty (30) days.
  It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.