Lead Manufacturing Engineer

2 weeks ago

California, Missouri, United States Blackhornvc Full time
Company Overview

Blackhornvc is a forward-thinking, innovative organization dedicated to revolutionizing the diagnostic landscape for fast-moving and immune-mediated diseases.

Our cutting-edge IntelliSep test is at the forefront of swiftly and accurately evaluating white blood cells, enabling healthcare professionals to assess a patient's risk of sepsis in a timely manner.

This groundbreaking test utilizes a biomechanical analysis of white blood cells obtained from a standard blood sample, delivering results in under 10 minutes. This rapid assessment provides physicians with critical information, empowering them to effectively triage patients suspected of sepsis and allocate their time to those who require immediate attention.

Moreover, our solution aids healthcare systems in optimizing resources, minimizing unnecessary treatments, and enhancing compliance with established guidelines.


Role Overview

As the Senior Manufacturing Engineer, you will play a pivotal role within the Operations team.

Your responsibilities will include acting as the primary technical liaison with our Contract Manufacturers (CMs), facilitating projects related to Capacity, Quality, and Cost in preparation for the product launch.

Your key responsibilities will encompass:

  • Supporting Design Control initiatives and preparations for commercial launch.
  • Collaborating with R&D to manage the product lifecycle of the in vitro diagnostic (IVD) system.
  • Conducting product testing, troubleshooting, and root cause analysis.
  • Implementing process control solutions for the IVD system.
  • Engaging in strategic supplier development projects and enhancing Design for Manufacturability (DFM).

This position necessitates on-site presence in the San Francisco office 4-5 days a week.


Key Responsibilities:
  • Serve as the primary technical contact for our Contract Manufacturer(s) during the initial commercial launch.
  • Identify and lead throughput expansion initiatives to meet production forecasts.
  • Oversee technical projects aimed at enhancing Quality and reducing Costs.
  • Manage design change deliverables to establish reliable manufacturing processes and risk management.
  • Collaborate with R&D and CMs on New Product Introduction (NPI) projects.
  • Support investigations into manufacturing non-conformance root causes and develop mitigation strategies.
  • Work with internal QA and CMs to maintain effective incoming QC inspections, in-line process validations, and lot release testing.
  • Assist in product lifecycle management (PLM) with R&D ENG, focusing on DFM opportunities and continuous improvement.
  • Lead projects to qualify additional or alternative suppliers as necessary.
  • Occasional domestic travel may be required.

Minimum Qualifications:
  • Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related field.
  • A minimum of 5 years of experience in product/process development within the Medical Device sector.
  • Proven experience managing contract manufacturers and suppliers.
  • Experience in developing product specifications, manufacturing work instructions, and managing non-conformance reports.
  • Knowledge of Risk Management (pFMEA), process controls, and validation.
  • Proficiency in Computer Aided Design (Solidworks).
  • Strong critical thinking skills and the ability to manage complex projects.
  • Excellent organizational and communication skills, effective in negotiation and conflict resolution.
  • Ability to prioritize tasks and drive process improvements in a fast-paced environment.

Preferred Qualifications:
  • Experience in developing and manufacturing capital systems, particularly IVD.
  • Experience in scaling up manufacturing processes.
  • Familiarity with principles of Design For Manufacturability (DFM).

EQUAL OPPORTUNITY EMPLOYER - Blackhornvc is committed to providing equal employment opportunities to all qualified applicants without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status.

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