Manufacturing Engineer

Praxt Talent LLC.; Salt Lake City (UT); On-site; USD 110,000 - 140,000; Full time

Job summary

Praxt Talent LLC in Salt Lake Valley, Utah, on-site, is seeking a Manufacturing Operations Engineer to drive line-level improvements and 90% yield on complex medical devices.

You will work in the cleanroom beside operators, own process setup and transfers, and collaborate across production, quality, automation, and R&D to simplify fixtures and instructions for faster, more reliable manufacturing.

Qualifications

• 5+ years of manufacturing, process, or NPI engineering in medical devices.
• Bachelor's degree in mechanical or manufacturing engineering.
• Hands-on experience working under 21 CFR 820 and ISO 13485.
• A track record of shipping line-level improvements: fixtures, process aids, and work instruction updates.
• Root cause analysis and structured problem-solving skills, including statistical analysis, DOE, and risk-based decision making.
• Comfort working in a cleanroom and building strong working relationships with operators and production leads.
• Enough familiarity with PLCs and automated equipment to explain what you need to an automation engineer (no programming required)

Responsibilities

• Line-level improvements beside operators in the cleanroom and ship improvements on a fast cadence: new fixtures, process aids, updated manufacturing instructions.
• Yield: push complex devices to 90% yield or better and keep working the problem until the numbers are met.
• Root cause analysis: find the root cause quickly using data, DOE, and risk-based judgment.
• Process work: run, refine, and stabilize processes such as braiding, lamination, forming, molding, coating, laser welding, reflow, and assembly; help bring up new ones including balloon bonding and adhesive joining.
• Production readiness: work on programs before transfer to full production, flag build issues, and recommend changes for speed and reliability.
• Automation readiness: set up processes so an automation team can automate them later, with clear requirements.
• Documentation: author the device master record package—manufacturing instructions, lot records, and quality documents; provide input to transfer team on validation plans and protocols.
• Fixtures and tooling: specify what a fixture or tool must do and work with engineers and toolmakers; building simple ones yourself is a plus.
• Cross-functional work: partner with production, quality, automation, and R&D to move programs from early builds to released products.

Skills

Manufacturing engineering

Process improvement

NPI engineering

Root cause analysis

DOE

Statistical analysis

Cleanroom experience

PLC familiarity

Cross-functional collaboration

Education

Bachelor's degree in mechanical or manufacturing engineering

Tools

PLC systems

Automation equipment

Job description

Manufacturing Operations Engineer, Medical Devices

Salt Lake Valley, Utah (on-site)

This job lives on the production line. You'll be next to the operators, making the build better every week. Our client manufactures minimally invasive medical devices, including catheters, sheaths, and delivery systems used in cardiology, pulmonology, and gastroenterology procedures. They build for some of the most recognized names in medical technology and also build and launch their own FDA-cleared products.

Growth is the headline. New customer programs are doubling the size of this engineering team, and the company was recently ranked among the fastest-growing companies in its state. It is privately held, debt-free, and promotes on merit: in the last year, an engineering manager moved up to associate director and one of their engineers moved into management. People who want to stay hands-on now have a principal-level technical track, too.

If you'd rather fix a process than just document it, read on.

About the role

You'll join a small operations team that gets new, highly complex devices running smoothly on the production floor. You'll be in the cleanroom beside the operators, finding what slows a build down or causes rejects, and fixing it fast. Nobody needs to ask you to improve a fixture, a process aid, or a manufacturing instruction. You just do it, and you keep at it until the line hits 90% yield or better.

You'll pick up each program before it transfers to production and stay with it through the transfer. After release, you'll support it for 6 to 12 months, then move on to the next one. This is not long-term sustaining work. You'll report to the leader of operations, who reports directly to the CEO and COO. You'll be given real ownership, and you'll be trusted to use it.

What you'll be doing

• Line-level improvement: Work beside operators in the cleanroom and ship improvements on a fast, steady cadence: new fixtures, process aids, and updated manufacturing instructions.
• Yield: Push complex devices to 90% yield or better, and keep working the problem until the numbers are met.
• Root cause analysis: Find the root cause of build problems quickly, using data, structured experiments (DOE), and risk-based judgment.
• Process work: Run, refine, and stabilize processes such as braiding, lamination, forming, molding, coating, laser welding, reflow, and assembly. Help bring up new ones, including balloon bonding and adhesive joining.
• Production readiness: Work on programs before they transfer to full production, flagging build issues and recommending changes that make the device faster and more reliable to produce.
• Automation readiness: Set up processes so a separate automation team can automate them later, and give that team clear requirements.
• Documentation: Author the device master record package: manufacturing instructions, lot records, and quality documents. Documentation is largely paper-based today. You'll also give input to the transfer team on validation plans and protocols.
• Fixtures and tooling: Spell out what a fixture or tool needs to do, and work with the engineers and toolmakers who build it. Building simple ones yourself is a plus.
• Cross-functional work: Partner with production, quality, automation, and R&D to keep each program moving from early builds to a stable, released product.

What you bring

• 5+ years of manufacturing, process, or new product introduction (NPI) engineering experience in medical devices (catheter experience is a plus, not a requirement)
• Bachelor's degree in mechanical or manufacturing engineering (strongly preferred)
• Hands-on experience working under 21 CFR 820 and ISO 13485
• A track record of shipping line-level improvements: fixtures, process aids, and work instruction updates
• Root cause analysis and structured problem-solving skills, including statistical analysis, DOE, and risk-based decision making
• Comfort working in a cleanroom and building strong working relationships with operators and production leads
• Enough familiarity with PLCs and automated equipment to explain what you need to an automation engineer (no programming required)

What sets our best people apart

• You don't wait to be told what's next. If a process can be better, you're already working on it.
• You own outcomes. Freedom here comes with responsibility, and you like it that way.
• You think like a future leader and want your scope to grow over time.
• Engineers who come from fast-moving NPI teams at contract manufacturers tend to thrive here. Spanish is a plus, since many operators, leads, and supervisors on the floor are bilingual.

Why this role

• Visibility: your leader reports directly to the CEO and COO, and your work is seen by the founders.
• Variety: a steady stream of new programs, including balloon catheters, microcatheters, and neurovascular devices, plus processes the team has never run before.
• Career paths: a proven fast track into management, or a principal-level technical track if you want to stay hands-on.
• A fast, decisive hiring process: one phone interview and one on-site visit.
• Full benefits: medical, dental, and vision insurance, HSA, life insurance, 401(k) with company match, and paid time off.

Location and work model

This is a full-time, on-site role in the Salt Lake Valley, Utah. You'll work in the cleanroom alongside operators, with your own workstation on the production floor, because that is where the improvements happen. Start and end times are flexible: the team is measured on results, not hours logged, and a heavy week can be balanced with a lighter one. Local candidates are preferred. Relocation support may be considered on a case-based basis.

Candidates must be authorized to work in the United States. Proof of eligibility is required at the time of hire.

We are an equal opportunity employer. Veterans and individuals with disabilities are encouraged to apply.