Position Summary:

We are seeking a motivated and talented Process Engineer to join the Substrates Team within the Manufacturing Technology & Transfer (MTT) Group. The MTT team plays a critical role in Consumables Development and Manufacturing by developing, scaling, and deploying manufacturing processes for new products within production environments.

In this role, you will provide technical leadership for new product introductions and process development activities. You will collaborate closely with Research & Development, Quality, Manufacturing, Supply Chain, and Engineering teams to develop, transfer, and sustain robust manufacturing processes that support successful product commercialization.

Responsibilities:
• Partner with R&D, Manufacturing, Supply Chain, and Quality teams to design and develop robust, high-volume manufacturing processes using Critical Parameter Management (CPM) principles.
• Design, execute, and analyze controlled experiments, including Design of Experiments (DOE), to optimize processes, improve yield and quality, and implement solutions in production environments.
• Drive product and process change management activities, including product configuration within ERP systems, to support successful product launches.
• Conduct root cause investigations using methodologies such as 8D, model-based problem solving, and statistical analysis to identify and resolve technical and compliance-related issues.
• Serve as a subject matter expert for critical-to-quality (CTQ) and critical-to-performance (CTP) process characteristics.
• Apply process engineering tools and methodologies, including FMEA, SPC, Gauge R&R, Critical Parameter Management, and Design for Manufacturability (DFM), to improve process capability and robustness.
• Lead technical project teams, drive execution of key deliverables, and identify risk mitigation strategies to achieve project milestones.
• Define technical requirements, create process documentation, and facilitate the transfer of manufacturing and quality control processes from development through scale-up and commercialization in a regulated environment.

Requirements:
• Strong written and verbal communication skills, with the ability to effectively collaborate across multiple functions is required.
• Proven ability to achieve objectives in a cross-functional team environment is required.
• Excellent analytical, problem solving, and critical-thinking skills are required.
• Experience with statistics, Statistical Process Control (SPC), and Design of Experiments (DOE) is an advantage.
• Experience in high-volume manufacturing within a high-tech consumables or related industry is an advantage.
• Familiarity with product development processes and project management methodologies is an advantage.

Education and Experience:
• B.S./M.S. in Chemical Engineering, Bioengineering, Biomedical Engineering, or Material Science equivalent with 2+ years of relevant experience in production sustaining, process development, scale-up, and validation.
• PhD in Chemical Engineering, Bioengineering, Biomedical Engineering, or Material Science with relevant experience in process development. Experience with production sustaining, process development, scale-up, and validation is an advantage.

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.