Summary:

We are seeking a hands-on Process Development Engineer II to join the Manufacturing Technology & Transfer (MTT) team.

This role develops, characterizes, scales, transfers, and sustains manufacturing processes for new consumable products. The primary technical scope includes precision adhesive and epoxy bonding, laser drilling and laser dicing, die or component singulation, automated pick-and-place, wire bonding, and consumable cartridge assembly. The engineer will work cross-functionally with R&D, Manufacturing, Quality, Supply Chain, Equipment Engineering, Facilities, and EHS to establish capable, scalable, safe, and compliant processes from development through production ramp.

Responsibilities:

• Own process development workstreams for new product introduction, from early feasibility and process definition through characterization, validation, transfer, and production ramp.

• Develop high-volume mechanical operations and assembly processes involving adhesive bonding, epoxy-based assembly, laser drilling, laser dicing, die or component singulation, automated pick-and-place, wire bonding, and consumable cartridge assembly.

• Translate product requirements and critical-to-quality characteristics into process requirements, control strategies, acceptance criteria, and manufacturing specifications using Critical Parameter Management principles.

• Plan, execute, and analyze controlled experiments, including design of experiments (DOE), to establish process windows, optimize performance, and improve yield, quality, reliability, and cycle time.

• Support the selection, development, qualification, and transfer of production equipment, tooling, fixtures, materials, automation, and inspection or metrology methods.

• Apply standard process-engineering tools, including process failure mode and effects analysis (PFMEA), control plans, statistical process control (SPC), Gage R&R, and process capability analysis (Cp, Cpk, Pp, and Ppk, as applicable).

• Perform structured root-cause analysis using methods such as 8D, fault-tree analysis, cause-and-effect analysis, and data-driven problem solving; implement and verify corrective actions.

• Generate clear technical documentation, including development plans, experiment protocols, technical reports, work instructions, process specifications, validation documentation, and manufacturing transfer packages.

• Drive product and process change control, and risk management, required for successful product launch and lifecycle support.

• Provide technical direction across project teams, identify technical and schedule risks, recommend mitigations, and communicate decisions and tradeoffs to stakeholders.

• Serve as a technical resource for critical process and product characteristics, supporting troubleshooting, supplier collaboration, production ramp, and sustained process performance.

Requirements:

• Bachelor's degree in Mechanical engineering, Manufacturing Engineering, Materials Science, Electrical Engineering, Bioengineering, Biomedical Engineering, or related technical field.

• Two or more years of relevant industry experience in manufacturing process development, new product introduction, process characterization, production support, scale-up, manufacturing transfer, improvement, qualification, or validation.

• Hands-on experience developing or sustaining at least one relevant process area, such as precision mechanical assembly, adhesive or epoxy bonding, laser micromachining, dicing or singulation, automated pick-and-place, wire bonding, or consumable assembly.

• Working knowledge of statistical methods, DOE, SPC, process capability, and measurement system analysis.

• Demonstrated ability to troubleshoot process interactions, analyze data, document conclusions, and implement practical manufacturing solutions.

• Strong written and verbal communication skills and demonstrated effectiveness working across engineering, manufacturing, and quality functions.

Preferred Qualifications:

• Master's degree in a relevant engineering or scientific discipline.
• Experience with adhesive selection and characterization, surface preparation or activation, precision dispensing, cure-process development, fixturing, and bond-strength testing.
• Experience with laser drilling, laser dicing, heat-affected-zone management, singulation, dimensional metrology, and defect reduction.
• Experience with automated assembly equipment, machine vision, motion control, pick-and-place, force-displacement monitoring, wire bonding, and in-line inspection.
• Experience developing high-volume manufacturing processes for consumables, medical devices, life-science products, semiconductor packaging, MEMS, or other regulated or high-reliability products.
• Experience with equipment and process qualification or validation, including installation qualification, operational qualification, and performance qualification (IQ/OQ/PQ), or an equivalent lifecycle framework.
• Experience with design for manufacturability and assembly (DFMA), supplier development, design transfer, and production ramp in a regulated manufacturing environment.

The estimated base salary range for the Engineer 2 - Process Development role based in the United States of America is: $82,500 - $123,700. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long-term growth in the role; therefore, most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.