Senior Production Engineer
2 weeks ago
Blackhornvc is an innovative, growth-oriented company dedicated to transforming the landscape of diagnostics and healthcare solutions.
Our flagship product is at the forefront of revolutionizing the assessment of immune-mediated diseases, providing rapid and precise diagnostics that empower healthcare professionals.
This cutting-edge technology evaluates white blood cells through a biomechanical approach, yielding results in less than 10 minutes, thereby enabling timely and informed clinical decisions.
As a Senior Manufacturing Engineer, you will play a pivotal role within our Operations team.
Your responsibilities will include acting as the primary liaison with our Contract Manufacturers (CMs), ensuring the successful execution of Capacity, Quality, and Cost initiatives as we gear up for product launch.
Your key duties will encompass:
- Overseeing Design Control processes and preparing for commercial introduction.
- 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, scale-up efforts, and Design for Manufacturability (DFM) enhancements.
This role necessitates a presence in the office on a regular basis.
Key Responsibilities:- Serve as the main technical contact for our Contract Manufacturer(s) during the initial commercial launch phase.
- Identify and lead projects aimed at increasing throughput to meet demand forecasts.
- Manage technical initiatives focused on enhancing Quality and reducing Costs.
- Oversee design change processes to establish reliable manufacturing protocols and risk management strategies.
- Collaborate with R&D and CMs on New Product Introduction (NPI) initiatives.
- Support investigations into manufacturing non-conformance and implement corrective actions.
- Work with internal Quality Assurance and CMs to maintain effective quality control inspections and validations.
- Assist in product lifecycle management, focusing on DFM opportunities and supply chain resilience.
- Lead projects to qualify additional suppliers as needed.
- Willingness to travel domestically as required.
- Bachelor's degree in Mechanical, Electrical, 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.
- Expertise in developing product specifications, manufacturing instructions, and non-conformance reports.
- Strong background in Risk Management (pFMEA), process controls, and validation methodologies.
- Proficient in Computer Aided Design (Solidworks).
- Exceptional critical thinking and project management skills.
- Excellent organizational and communication abilities, particularly in negotiation and conflict resolution.
- Adept at prioritizing tasks and driving process improvements in a dynamic environment.
- Experience in developing and manufacturing capital systems, particularly IVD.
- Background in scaling manufacturing operations.
- Familiarity with Design For Manufacturability (DFM) principles.
EQUAL OPPORTUNITY EMPLOYER - Blackhornvc is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status.
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