Process Engineer II

Biolinq Incorporated•San Diego, CA

33m•$80,000 - $100,000•Hybrid

About The Position

The Process Development Engineer II in Technical Operations is responsible for ensuring the ongoing quality of manufactured products through monitoring, controlling, and troubleshooting manufacturing processes and systems. This will be accomplished through the implementation of controls, specifications, process improvements, and/or corrections where appropriate, all while maintaining strict regulatory and quality system compliance. The successful candidate will drive operational excellence by applying scientific and statistical methods to enhance product quality, reduce costs, improve product yields, and ensure efficient technology transfers.

Requirements

BS Degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Science, or a related field.
Minimum 3-5 years of related experience.
Experience in process development methodologies, including DOE, statistical analysis, and characterization techniques.
Working knowledge of statistical software (e.g., JMP) for data analysis.
Strong knowledge of Design Controls, Process Validation (IQ/OQ/PQ), and Risk Management (ISO 14971).
Experience with high-volume manufacturing processes such as micro-assembly, automation, dispensing, adhesive bonding, or precision printing.
Familiarity with materials commonly used in medical devices (polymers, adhesives, metals) and their processing behaviors.
Experience working in GMP environment and adhering to quality and regulatory standards.
Proficiency in Microsoft Office tools.
Consistent character of respect. Garners trust through teamwork and communication with others.
Creative and forward-thinking mindset.
Self-awareness about strengths and areas of development.
Ability to prioritize, multi-task, and meet deadlines.
Ability to work in a fast-paced and dynamic environment.
Desire for self-growth and willingness to adapt to and tackle new challenges.

Nice To Haves

Experience with standard electrical, mechanical, and wet lab test equipment

Responsibilities

Collect and analyze production data using statistical process control (SPC) and other statistical methodologies to drive data-backed decisions that improve product quality and process reliability.
Optimize data acquisition and analysis tools and systems.
Assist in the development, characterization, and optimization of critical manufacturing processes for Biolinq’s device assembly.
Analyze existing production processes to identify constraints, bottlenecks, and improvement opportunities using scientific and statistical methods.
Execute Design of Experiments (DOE) and process characterization studies to establish robust process parameters and specifications.
Partner with the Quality team to ensure all manufacturing processes comply with FDA regulations, ISO 13485 standards, and company quality policies.
Perform root cause analysis and implement corrective actions for manufacturing issues using methodologies like PFMEA, Control Plans, and CAPA.
Support the validation of test methods and manufacturing equipment (IQ/OQ/PQ).
Partner closely with R&D to influence material selection, tolerance analysis, and assembly methods that enhance manufacturability.
Collaborate with the Quality team to ensure all process development activities comply with Design Control requirements and applicable regulations (ISO 13485, FDA QSR).
Work with the Supply Chain team to evaluate new materials and supplier capabilities from a technical process standpoint.
Coordinate with Quality Assurance, Maintenance, and Production teams to troubleshoot issues and implement corrective actions efficiently.
Work closely with Operations Engineering to support the development and execution of scale-up strategies to transition validated processes from pilot lines to commercial manufacturing and ultimately to contract manufacturers (CMs) or internal high-volume manufacturing.
Ensure all process documentation, including work instructions and specifications, are technically accurate and compliant with design outputs.