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 development 
• Lean manufacturing or Six Sigma experience. 

Why Join Us 

At ResMed, 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 ResMed, 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 position qualifies for the following benefits package: 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. 

Individual pay decisions are based on a variety of factors, such as the candidate’s geographic work location, relevant qualifications, work experience, and skills. 

At ResMed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.  A reasonable estimate of the current range for this position is: $117,000 to $175,000

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.