Sr. Hardware, Manufacturing Engineer

We are seeking a hands-on Senior Hardware Manufacturing Engineer to support the design, development, and industrialization of tooling, fixtures, and production equipment for electro-mechanical medical devices. This role owns the hardware realization strategy—from early concept tooling through outsourced fabrication and production deployment.  You will work closely with R&D, Quality, Operations, and suppliers to translate process requirements into robust mechanical solutions, lead tool design activities, and fabrication activities (internally and externally), to ensure production systems are reliable, scalable, and compliant in a regulated environment. 

Keyt Responsibilities

• Lead hands-on manufacturing process development for electro-mechanical medical devices from prototype through production  
• Drive DFM/DFA reviews with R&D, ensuring designs meet manufacturability and regulatory requirements 
• Lead design, development, and validation activities for production tooling, fixtures, jigs, and test equipment ranging from simple manual tools to complex automated systems 
• Author and execute process validations (IQ/OQ/PQ) and support design transfer activities 
• Create and maintain production equipment documentation, including equipment specifications, PFMEA, equipment drawings, and BOMs.  
• Manage external machine shops, automation vendors, and contract manufacturers through RFQ, DFM review, and build iterations 
• Support supplier qualification and development, including on-site visits and process audits 
• Support low-volume pilot builds, production ramps, and continuous improvement initiatives 
• Train and mentor technicians and junior engineers on processes, tools, and best practices 
• Partner with Quality to support complaints, NCRs, audits, and inspections (FDA, ISO 13485) 

Let’s talk about Qualifications and Experience
Required:

• Bachelor's degree in mechanical, Electrical, Manufacturing, or Biomedical Engineering (or related field) 
• 7+ years of hands-on manufacturing engineering experience, preferably in medical devices or other regulated industries 
• Proficiency in 3D CAD (SolidWorks, Creo, or equivalent) with strong drawing and GD&T skills 
• Strong experience supporting electro-mechanical assembly in a production environment 
• Experience working with machine shops and contract manufacturers for custom fabrication 
•  Direct experience with process validation (IQ/OQ/PQ) and design transfer 
•  Working knowledge of GMP principles 
•  Demonstrated ability to troubleshoot complex manufacturing issues on the production floor 
•  Experience creating clear, compliant manufacturing documentation 
•  Strong collaboration and communication skills across R&D, Quality, and Operations 

Preferred:

• Experience performing tolerance stack-up analysis and design for reliability 
• Familiarity with fixture design for bonding, adhesive curing, laser welding, or   ultrasonic welding 
• Experience with contract manufacturers and supplier audits 
• Familiarity with IPC standards, GD&T, and tolerance analysis 
• Experience with automation, vision systems, or functional test