Sr. Hardware, Manufacturing Engineer
About The Position
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.
Requirements
- 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
Nice To Haves
- 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.
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)
Benefits
- comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance
- Employees accrue fifteen days Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
