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.

Qualifications

Required Skills and Experience

Minimum of 8 years or Master's plus 6 years in manufacturing engineering, preferably in medical device, catheter, needle, or single-use disposable manufacturing environments Experience with precision mechanical assemblies, polymer processing, and joining processes (e.g., laser welding, bonding, reflow).

Working knowledge of Six Sigma tools, Cpk, DOE, statistical process control Root cause analysis experience (8D, Fishbone, DMAIC)

• Familiarity with ALM/PLM systems for ECO and risk management Basic coding proficiency in Python for data analysis or automation
• Strong communication skills across technical and non-technical teams
• Ability to manage multiple projects in a fast-paced NPI environment Willingness to travel occasionally to suppliers or manufacturing sites Required Education and Training BS in Mechanical Engineering, Materials Engineering, Biomedical Engineering, or related field

Preferred Skills and Experience

Experience in medical device manufacturing (ISO 13485)

• Familiarity with ISO 9001 and regulated product development environments Hands-on experience with catheter, needle, or minimally invasive device assemblies, including packaging and sterilization validation Experience with Agile and SAP systems or equivalent
• Demonstrated success in experimental design and structured problem solving Experience in Controlled Environment Rooms (CER)