Our team is made out of experts in Regulatory Affairs, Quality Assurance, Clinical Evidence, medical instruments and implantable devices. We will taylor our team based on your specific project needs
Mauricio Rodriguez, P.Eng. M.Eng.
Mauricio, the founder of Enerxen Inc., is a highly accomplished Professional Engineer with a career spanning over 15 years in the medical devices industry. With a keen focus on Development, Quality Management Systems and Regulatory Affairs, Mauricio has made significant contributions to the field.
Mauricio has worked in various roles for major medical device companies in both Canada and the USA. His extensive industry experience paved the way for his entrepreneurial journey, where he became the founder and owner of Enerxen Consulting Inc., Mauricio brings a wealth of knowledge in evaluating and designing complex systems and processes, all while maintaining a strong grasp of quality systems engineering principles.
Mauricio’s skill set extends beyond technical expertise. His leadership skills shine through in his roles as a project manager, and demonstrated mastery in training facilitation.
Mauricio specializes in several critical areas within the medical device industry, including Quality Systems, Risk Management, Post-Market Surveillance and Continuous Improvement (CAPA). His dedication to ensuring quality, mitigating risks, and driving continuous improvement exemplifies his commitment to the highest standards in the field.
With a career that has taken him from renowned companies in both the US and Canada to the establishment of Enerxen Inc., Mauricio is a valuable asset to any team, and his contributions are vital to the success of Enerxen Inc
With over 15 years of dedicated experience in the medical device industry, stands out as a seasoned Quality and Regulatory Manager. Her career is marked by a profound expertise in dynamic environments, specifically focusing on Software as a Medical Device (SaMD) and AI/ML medical devices. Otty’s extensive background has equipped her with a deep understanding of the complexities and challenges in these cutting-edge sectors.
Her journey in the industry is distinguished by her significant contributions to the implementation of electronic Quality Management Systems (eQMS). This has not only showcased her proficiency in ensuring compliance and maintaining high standards of quality, but also her ability to navigate and lead within the rapidly evolving landscape of medical technology.
Otty’s leadership and strategic approach have been instrumental in driving quality improvements and regulatory compliance across the organizations she has been part of. Her role extends beyond managing systems; she’s a catalyst for change, constantly pushing the boundaries to incorporate innovative solutions in the realm of medical devices.
In summary, Otty Angulo’s career is a testament to her unwavering commitment to excellence in the quality and regulatory aspects of the medical device industry, with a special focus on the emerging fields of SaMD and AI/ML technologies.
Melissa is a seasoned regulatory affairs expert with over two decades of experience in the medical device industry. Her extensive background spans various facets of regulatory affairs, making her a valuable asset to our team. With a strong focus on dental devices, implantable medical devices, in vitro diagnostics, and quality systems, Melissa has a proven track record of excellence.
Throughout her career, Melissa has taken the lead on numerous critical initiatives, including overseeing regulatory submissions (PMA devices, endovascular devices and orthopedic implants), coordinating FDA inspection activities for international manufacturing sites, and spearheading FDA Warning Letter resolution efforts. She has also played a pivotal role in remediation activities related to CAPA, complaints, validation, and design control, showcasing her strengths in these areas.
Melissa’s expertise extends to defending external audits, including those conducted by the FDA and Notified Bodies, as well as conducting audits herself. Her proficiency in Validation Review, Cleanroom and Sterilization processes, and Labeling Review further solidifies her reputation as a regulatory authority.
She possesses an in-depth knowledge of quality systems compliance with FDA, ISO 13485, European MDR, Health Canada Medical Device and Tissue regulations, Japan JPAL, California FDB, China SFDA, Brazil ENVISA, and US Tissue Bank requirements. Additionally, Melissa has an impressive international product submission record, covering regions such as the US, Europe, Canada, Australia, Japan, China, Brazil, and Mexico.
Melissa’s expertise isn’t confined to paperwork; she has a deep understanding of various medical devices, including dental and orthopedic implants, human and animal bone and tissue products, patient-specific products using CAD/CAM technology, and computer/software products. With her wealth of knowledge and experience, Melissa is a driving force behind our regulatory affairs success.
Mateo Rodriguez, BBA
Mateo contributes to Enerxen’s business administration and development activities and works with Enerxen consultants to coordinate projects from companies around the globe. A key part of his responsibilities include managing financial matters with our clients. Mateo has accounting, project management, and enterprise management experience.
Marekting and B.DEV
Mitchell is a dynamic addition to our team with a strong educational background and a wealth of experience. Currently pursuing a Bachelor of Commerce degree, specializing in marketing, with a minor in communication at Toronto Metropolitan University, his passion for marketing, strategic thinking, and dedication to results make him a perfect fit as our Marketing and Business Development Assistant.
Mitchell has led advertising campaigns, shaping the company’s voice and branding. Proficient in data-driven decision-making, he leverages tools like Adobe Suite and Google Analytics to craft and evaluate campaign performance. Mitchell’s entrepreneurial spirit shines through, having successfully secured a government grant for a small business startup, highlighting his determination and innovation.
Student – Remote: Job ID # Studentfall001
- Assists in developing systems for monitoring quality and ensuring compliance.
- Collaborate across functions and sites, leveraging quality knowledge to troubleshoot problems, interpret data and determine next steps based on risk-based approach.
- Manage non-conformances, complaint records, and corrective and preventive actions (CAPAs)
- Support harmonization and remediation activities
- Assist with regulatory activities
- Follows guidance and direction to ensure ISO/Quality system compliance with 21 CFR part 820 and ISO 13485:2016
- Manage maintenance, completeness and accuracy of Quality records
- Create and review quality processes and procedures
- Collect, analyze, trend and report out on quality metrics
- Drive a culture of continuous improvement
- Supports complex, cross-functional quality issues in a variety of subject matter areas (e.g. electrical, mechanical, chemistry and software)
- Proactively investigating, identifying, and implementing best-in-class Quality Engineering practices.
Bachelor’s or Master’s Student in Mechanical Engineering, Biomedical Engineering, Quality Systems Engineering, or related technical discipline, preferred.
Skills / Highlights
- Excellent communication, collaboration and interpersonal skills with the ability to facilitate team interactions, partner with and influence key stakeholders.
- Work with diverse teams
- Knowledge of continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
- Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
- Knowledge of quality standards (e.g., 21 CFR Part 820, ISO 13485, ISO14971) and Quality Management System design
- Quality tools e.g. FMEA, Risk Analysis, Root Cause Analysis
- Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project)