Manufacturing Engineer

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.

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.

• 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.

• 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…