Malinda Elien
About Malinda Elien
Malinda Elien is a Principal Technical Program Manager with extensive experience in the Medical Device industry, specializing in Quality Management Systems and FDA filings. She has held various engineering and management roles, including positions at Stratos Product Development and Cenorin, and has a strong academic background in Aeronautics and Astronautics from MIT.
Current Role at Fresh Consulting
Malinda Elien serves as the Principal Technical Program Manager at Fresh Consulting, a position she has held since 2022. In this role, she oversees technical programs and ensures the successful execution of projects. Her responsibilities include managing cross-functional teams and aligning project goals with client expectations. Prior to this, she worked as a Senior Technical Program Manager at the same company from 2020 to 2022, further solidifying her expertise in program management.
Previous Experience in Engineering and Project Management
Malinda Elien has extensive experience in engineering and project management within the Medical Device industry. She worked at Stratos Product Development as a Project Manager from 2011 to 2015 and as a Senior Mechanical Engineer from 2010 to 2011. Additionally, she served as the Director of Engineering at Cenorin from 2018 to 2020 and as a Project Manager for 8 months in 2018. Her career began at Microscan, where she worked as a Mechanical Engineer for 11 years.
Education and Expertise in Aeronautics and Astronautics
Malinda Elien has a strong educational background in Aeronautics and Astronautics, having studied at the Massachusetts Institute of Technology (MIT). She earned her Bachelor of Science (SB) degree from 1996 and later achieved a Master of Science (SM) degree from 1999. This robust foundation in engineering supports her expertise in Quality Management Systems and FDA filings, particularly in the Medical Device sector.
Certifications and Professional Contributions
Malinda Elien is a certified Project Management Professional (PMP), which underscores her commitment to project management excellence. She has contributed to the field by authoring an article titled 'Debunking the
Background in Medical Device Development
Malinda Elien has a comprehensive background in Research and Development (R&D) within the Medical Device sector. She has worked on durable medical equipment and has experience in reprocessing reusable plastic medical devices. Her track record in product development highlights her ability to navigate the challenges of the medical device industry effectively.