About the Company
We are a Class III cardiac device manufacturer and market leader based in Austin, Texas. Around 1,500 employees today and tripling that over the next three years. Every engineer we hire owns their area. There are no floaters here.
The Role
This Process Engineer III sits in our Final Assembly and Packaging area. You will own manufacturing processes, drive improvements, support equipment validations, and collaborate across engineering, quality, and operations in a fully FDA and ISO regulated environment. The role is floor-based and comes with real process ownership from day one.
What You Will Be Doing
- Owning manufacturing processes across final assembly and packaging
- Troubleshooting equipment and processes through hands-on root cause analysis
- Leading IQ/OQ/PQ validations and supporting new equipment start-up and debug
- Driving continuous improvement to cut errors and improve yields and cycle times
- Coordinating Engineering Change Notices for process, material, and design changes
- Supporting new product launches by providing process engineering input
- Partnering with quality on CAPA investigations and audit deliverables
- Developing and maintaining SOPs and operations documentation
What We Are Looking For
- Bachelor's degree in Engineering with 4 to 6 years of experience, or Master's with 2 to 4 years
- Process engineering experience in a regulated manufacturing environment
- Hands-on floor presence, someone who diagnoses problems and not just documents them
- Strong problem-solving skills including root cause analysis, SPC, CAPA, and process capability
- Lean manufacturing experience
Nice to Have
- GMP or GDP manufacturing environment experience
- Experience automating manual manufacturing processes
- Cleanroom process experience
- Experience troubleshooting industrial electronic hardware
- CAD software familiarity
- Green Belt in Lean or Six Sigma
Compensation and Benefits
- Base salary up to $120,000
- 7% annual bonus
- Equity participation, uncapped above target
- Full medical, dental, and vision
- 401K with employer contribution
- Employee stock purchase plan
- Unlimited PTO with 10 paid company holidays
- Tuition reimbursement
- Standard hours 7:30AM to 4:30PM