Sr NPI Manufacturing Engineer

Job Description

Primary Function of Position
We are seeking a collaborative and technically strong Manufacturing Process Engineer to support next-generation needles and accessories for advanced bronchoscopic instruments. In this role, you will lead the development, validation, and continuous improvement of manufacturing processes for precision flexible needles, catheters, and single-use accessory assemblies. You will partner closely with Design Engineering, Materials Engineering, Quality, and Supplier teams to ensure robust, scalable processes that deliver exceptional product performance and patient safety.

Essential Job Duties

• Develop, release, and validate scalable manufacturing processes for next-generation, single-use and multi-use accessory assemblies.

• Support development of joining and forming processes such as laser welding, adhesive bonding, tipping, grinding, crimping, swaging, polymer reflow, and more.

• Define robust assembly and inspection methods for precision needle, catheter, and small-bore tubing subassemblies.

• Ensure high-quality build and test practices, including tensile, pull, puncture, and dimensional testing, as well as packaging and sterilization compatibility.

• Perform statistical analysis including Cpk, process capability analysis, DOE, ANOVA, regression analysis

• Monitor yield trends and implement corrective actions to improve manufacturability and reliability.

• Create and maintain pFMEAs and mitigate identified risks.

• Collaborate with automation, equipment, and test engineering to improve automated test coverage and data traceability.

• Partner with:

  • Mechanical and Materials Design Engineers on DFM/DFX reviews

  • Clinical and Human Factors teams to understand needle and accessory performance and usability needs

  • Supplier Engineering on tubing, extrusions, machined, molded, and packaging components

• Support early NPI ramp to launch

• Provide hands-on support to the production line during issue resolution and scale-up.

• Lead root cause investigations involving needles and accessories.

• Implement yield and cycle time improvements in needle and accessory assembly processes.

• Develop and revise detailed manufacturing process instructions for processes.

• Train technicians and manufacturing staff in new processes and quality standards.