Process Development Engineer IV

Overview

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.

Responsible for activities and area goals through design, development, and transfer at the component and finished product level.

• Support R&D on identifying critical to quality attributes (CQAs), test development, characterization, and specifications.
• Validate critical in-process test methods to demonstrate suitability for intended use.
• Identify opportunities to scale and automate test methods for capacity and capability.
• Develop trace matrix linking user needs, design, inputs, and system and sub-system requirements to process specifications (PSD).
• Identify “leap” technologies enabling scale, demonstrate proof of concept and business case, and down-select for implementation into manufacturing pipeline.
• Manage equipment lifecycle through requirements (URS, ERD), concept, site acceptance (FAT, SAT), and induction (EB, IQ).
• Develop processes, fixtures, and equipment that meet business and manufacturing needs.
• Design experiments to baseline, characterize, and optimize process variables.
• Define preventative maintenance and setup procedures for new equipment.
• Develop test plan, qualification templates, and risk assessments for process validation.
• Complete initial line qualification activities to support regulatory filing and product launch (MVP, OQ/PQ/PV).
• Develop production control plan to monitor product consistency in manufacturing.
• Develop pilot manufacturing layout and cell design for product flow.
• Support delivery of pre-commercial builds for unreleased product or process iterations.
• Release documents for build traceability of new product or process iterations (MPI, DHR).
• Provide capital requirements for capacity and budget planning.
• Integrate lessons learned and opportunities from current product into future generations.
• Provide input to ensure product is designed for manufacturability and assembly (DFM).
• Maintain repository of key insights and tribal knowledge for sustaining engineering team.
• Characterize noise factors (storage, environment, etc.) and process cliffs for scaling robustness.
• Collaborate with R&D and Supply Chain to model product cost for anticipated volumes.
• Assess viability of product and process to meet manufacturing and business needs.
• Document engineering tradeoffs and deferred changes for process transfer.
• Complete supporting documents for design transfer (DHF, DMR, etc.).
• Provide technical input for product- and manufacturing-related non-conformances, risk management, and manufacturing strategy.
• Re-evaluate manufacturing release criteria for yield and/or performance improvement.
• Participate in review meetings to align on production performance and strategic initiatives.
• Implement new manufacturing equipment to support scaling, including at key suppliers.
• Execute strategic initiatives to increase capacity and meet anticipated scaling needs.
• Implement advanced manufacturing strategies to support maturation of technologies and competencies needed for high-volume manufacturing.
• Design or modify equipment and fixtures to mitigate variation sources in manufacturing.
• Complete change impact assessment to align implementation plan for proposed changes.
• Evaluate and implement 2nd source materials for manufacturing supply risk.
• Develop qualification process to evaluate performance of incoming raw material lots.
• Support evaluation, selection, development, and qualification of key suppliers.
• Develop test methods and material specifications for critical components.
• Characterize product impact of sterilization, shipping, and storage for commercial flexibility.

• BS Degree in Mechanical Engineering, Bioengineering, Chemical Engineering, Manufacturing Engineering, or scientific discipline required.
• Minimum 8-12 years related experience, including…