Process Development Engineer IV (Staff)

Biolinqorporated•San Diego, CA

About The Position

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

Requirements

BS Degree in Mechanical Engineering, Bioengineering, Chemical Engineering, Manufacturing Engineering, or scientific discipline required
Minimum 8-12 years related experience, including years of higher-level education (MS, PhD)
Experience in design of experiments and statistical tools (ANOVA, t-test, etc.)
Experience with Fishbone, A3, 5Y, and other root cause investigation tools
Strong understanding of process interactions (inputs, outputs) that are both technical and system related
Expertise with scaling manufacturing processes to commercial volumes
Experience with budgeting, cost management, modeling, and preparing business proposals (ROI, NPV) for new initiatives seeking executive approval
Strong understanding of FDA 21 CFR Part 820 and ISO 13485 quality and regulatory standards
Experience with lean manufacturing and six sigma methodologies (preferred)
Experience with design for manufacturability concepts and product development lifecycle (preferred)
Experience with standard electrical, mechanical, and wet lab test equipment (preferred)
Strong leadership skills, including the ability to set goals, allocate resources to appropriate priorities, and provide constructive feedback to foster positive relationships
Proficiency in Microsoft Office tools
Proficiency with JMP, Minitab, or equivalent statistical software
Experience with ERP, MES, and other manufacturing systems
Proficiency in BMRAM or equivalent asset management system
Expertise in several specialty skillset, including injection molding, welding, analytical chemistry, microscopy, metrology, adhesives, or electronics packaging
Role model for what kindness looks like. Actively levels up those on the team through example setting, guidance, and support. Empowers others to make effective decisions
Excels at identifying solutions to accelerate team’s learning of the problem space
Strong organizational planning and ability to hold others accountable. Breaks down silos within and across teams to ensure forward progress and collective success
Ability to take decisive action and deliver tangible results in a cross-functional organization. Leadership aptitude of teams, projects, and programs

Nice To Haves

Experience with lean manufacturing and six sigma methodologies (preferred)
Experience with design for manufacturability concepts and product development lifecycle (preferred)
Experience with standard electrical, mechanical, and wet lab test equipment (preferred)
Proficiency in Solidworks or equivalent CAD software (preferred)
Experience with MS Project, Visio, and other project management tools (preferred)
Experience with manufacturing database, controls, and vision (preferred)
Experience with Altium or other electronics design software (preferred)

Responsibilities

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