Senior Mechanical Process Engineer

Biological Dynamics, Inc. is a biotechnology company committed to improving global health outcomes by detecting disease in its earliest stages. Our proprietary Verita™ platform simplifies access to biomarkers, nanoparticles, and nucleic acids, enabling differentiated multiomics applications. We are applying our proprietary methods with machine learning to detect early-stage cancer and other diseases. For more information, please visit www.biologicaldynamics.com.

Our talented staff thrive in an open working environment where curiosity, insights and vision are part of the equation. With an inclusive culture and comprehensive benefits package, we offer a terrific opportunity to discover, learn and grow. If you are ready to be inspired, challenged, and want to join a dynamic team where you can contribute to developing a revolutionary new way to understand diseases and save lives, you have come to the right place.

Job Summary

Biological Dynamics is seeking a Senior Mechanical Process Engineer to work onsite in San Diego, Ca.  The Senior Mechanical Process Engineer is responsible for developing internal and external manufacturing processes to achieve quality, cost, efficiency, and volume goals for Biological Dynamics.  The Senior Mechanical Process Engineer is responsible for hardware platform new product introduction and ongoing line support.  This position also reviews and troubleshoots device anomalies and deviations, as well as monitors and improves the performance efficiency of the manufacturing processes through analysis and data process validation and design of experiments (DoEs). 

• Responsible for product life cycle - New Product Introduction (NPI) and transfer engineering through to line support and obsolescence or hardware consumables and instrumentation.
• Develops, configures, and optimizes industrial processes from inception through to start up and certification. Designs, develops, and improves manufacturing processes, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety.
• Assists in identifying process requirements, process capability (Cp/Cpk) of processes and equipment, and evaluates process options for cost reduction or capacity improvement.
• Identifies, justifies, purchases, and incorporates new capital equipment based on process requirements.
• Applies analytical techniques including design of experiments (DoE), statistical process control (SPC) to diagnose process issues.
• Conducts analysis of variation (ANOVA) and develops solutions to improve process control by reducing variability and retargeting processes. Sets and monitors control limits and responds to out of control (OOC) events before they become out of specification.
• Analyzes and improves industrial processes to increase capacity, reduce cost, improve sustainability, and maximize profitability. Drives cost effective manufacturing utilizing lean manufacturing methods and tools (Kaizen, TMM, lean-six).
• Maintains an effective process change control environment. Conducts process risks analysis using process failure mode effects analysis techniques (PFMEA) to identify risk factors, develops, and implements process risk mitigation plans.
• Participates in teams or lead groups of manufacturing engineers and technicians to support the production and development for Biological Dynamics’s proprietary products and applications.
• Leads Quality projects under ISO 13485, 14971, FDA 510(k), PMA, and related standards.
• Writes and executes process and equipment validations (IQ/OQ/PQ).

Experience/Education/Skills

• Typically requires a minimum of 5 years of related experience and a Bachelor's degree in a scientific/engineering discipline, or 3 years of experience and a related Master's degree, or a scientific/engineering PhD, or equivalent combination of education and experience.
• Experience in process validation with writing protocols, report analysis, result presentation, risk assessment, IOPQ, and TMV.
• Strong project management skills including experience working on several projects simultaneously; initiative in taking on and completing projects and redistributing attention as necessary.
• Previous experience with statistical analysis software, i.e., JMP or Minitab required.
• Previous experience working in SolidWorks or AutoCAD preferred.
• Experience with following tools: Design for Manufacturability (DFM) practices, Statistical Process Control (SPC) and data analysis software, Process Failure Mode Analysis (PFMEA), Process Mapping, Root Cause and Corrective Action (RCCA) Process, Design of Experiments, ANOVA, Gage R & R preferred. 

The estimated base salary range for this role is: $95,000 - $105,000 annually. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. 

Biological Dynamics is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, religious creed, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law (such as cancer), genetic information, or any other characteristic protected by applicable federal, state or local laws and ordinances.

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