What are the responsibilities and job description for the Advanced Manufacturing Engineer II position at BRIOHEALTH SOLUTIONS INC?
About Us
We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enabling chronic MCS therapy to be accessible to more patients across the globe.
Job Summary
BrioHealth Solutions is seeking an experienced and driven Advanced Manufacturing Engineer to join our dynamic team. As an Advanced Manufacturing Engineer, you will play a pivotal role in the transfer of products and process technologies from R&D to Manufacturing ensuring safety, quality, and regulatory goals are met.Your expertise will contribute to the organization's operational efficiency and overall success.
Responsibilities
Design Transfer
- Collaborate with R&D, Manufacturing Engineering, and Quality to transfer new products into production
- Develop and implement robust manufacturing plans, from concept through commercialization.
- Design and optimize manufacturing processes, equipment, tooling, and fixtures to improve safety, quality, and efficiency.
- Support all validation activities, including protocol development and execution (PC/IQ/OQ/PQ).
- Lead efforts in pFMEA, DFM/DFA, risk analysis, and development of process control strategies.
Process Support & Continuous Improvement
- Partner with Manufacturing and Quality teams to investigate issues, identify root causes, and drive yield and throughput improvements.
- Apply knowledge of medical device assembly, cleanroom protocols, and advanced fabrication techniques.
- Develop and deliver training materials for newly implemented processes.
Supplier Management
- Build and maintain strong relationships with key suppliers of components, materials, and equipment.
- Evaluate and qualify alternative suppliers to support business continuity and innovation.
Cross-Functional Collaboration
- Lead and coordinate cross-functional teams to introduce and integrate new manufacturing technologies.
- Work closely with stakeholders in R&D, Quality, Regulatory, and Manufacturing to meet project and business goals.
- Identify technical risks and propose practical solutions while fostering trust across all levels of the organization.
Other Responsibilities
- Contribute to the development of intellectual property.
- Accept additional assignments as delegated by leadership.
Qualifications
- Bachelor’s degree in Mechanical, Manufacturing, Electrical Engineering, or a related field.
- Minimum of 2 years of experience in product or process development.
- Experience in medical device, pharmaceutical, or biotechnology industries highly preferred.
- Familiarity with FDA and ISO regulations (e.g., ISO 13485, 21 CFR Part 820, EU MDR) preferred.
- Strong background in quality systems, including DFM, DOE, SPC, and continuous improvement methodologies.
- Proficient in SolidWorks and Microsoft Office 365 applications.
- Excellent communication, organizational, and interpersonal skills.
- Detail-oriented with a hands-on approach and problem-solving mindset.
