Senior Manufacturing Automation Engineer

About the role

The Senior Manufacturing Automation Engineer will own and lead automation projects for regulated medical device manufacturing, ensuring safety, quality, and scalability. You will act as the technical bridge between R&D, Operations, Quality, and equipment suppliers.

Key responsibilities

• Own equipment lifecycle from concept through retirement, including supplier selection, FAT, SAT, qualification, and sustaining support.
• Author and execute URS, validation protocols (IQ, OQ, PQ) and manage deviation resolution.
• Design fixtures, nests, adapters and poka‑yoke devices to improve ergonomics and reliability.
• Lead cross‑functional design reviews and serve as primary technical interface with automation vendors.
• Develop SOPs, work instructions, PM recommendations and support CAPA activities to maintain GMP, FDA and ISO 13485 compliance.

Required profile

• Bachelor’s degree in Mechanical, Manufacturing, Electrical, Mechatronics or related field.
• 7+ years of automation or equipment engineering experience in a regulated medical device environment.
• Proven track record owning manufacturing equipment through installation, qualification and change management.
• Strong ability to read mechanical drawings, electrical schematics and pneumatic diagrams.

Required skills

• SolidWorks CAD proficiency.
• Experience with machine‑vision systems such as Cognex or Keyence.
• Knowledge of robotics, servo motion, pneumatic systems, sensors and PLC/HMI control.
• Familiarity with FDA regulations, GMP, ISO 13485, risk management and change control processes.

What we offer

• Competitive salary $115,000‑$145,000 USD per year, commensurate with experience.
• Comprehensive medical and dental coverage, FSA/HSA options, 401(k) match.
• Generous vacation accrual and paid holidays.
• Opportunity to impact life‑changing medical devices in a fast‑growing environment.