Sr. Hardware, Manufacturing Engineer; Onsite

Position: Sr. Hardware, Manufacturing Engineer (Onsite)
Location: California

Sr. Hardware, Manufacturing Engineer page is loaded## Sr. Hardware, Manufacturing Engineer locations:
Chatsworth, CA, United Statestime type:
Full time posted on:
Posted Todayjob requisition :
JR 049590

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 (Solid Works, 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 development
* Lean manufacturing or Six Sigma experience.
** Why Join Us
** At Res Med, we believe in **“Do it Best, Do it Together.”
** You’ll join a forward-thinking team driving innovation in medical device manufacturing — where engineering precision meets purpose. Together, we’re creating smarter, safer, and more sustainable solutions that help people around the world live healthier lives.

We are shaping the future at Res Med, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world’s best talent. We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members.

Employees scheduled to work 30 or more hours per week are eligible for benefits. This…