What a Manufacturing Engineer at a Medical Device Company wishes they had known before their Medical Device career
Emma's experience as a Manufacturing Engineer revealed the centrality of this role in medical device development, stating "how central we are to every single change," from product development to navigating regulatory affairs and global compliance. This highlights the extensive collaboration and multifaceted nature of bringing a "complicated class three medical device product" to market.
Regulatory Affairs, Quality Assurance, Supply Chain Management, Cross-functional Collaboration, Product Development
Advizer Information
Name
Job Title
Company
Undergrad
Grad Programs
Majors
Industries
Job Functions
Traits
Emma Stramberg
Manufacturing Engineer
Medical Device Company
Cal Poly SLO
N/A
Engineering - Biomedical
Biotechnology & Pharmaceutical, Manufacturing, Operations & Supply Chain
Operations and Project Management
Greek Life Member, LGBTQ
Video Highlights
1. Manufacturing engineers are central to all stages of product development and implementation, from initial process development to final production.
2. The role involves significant interaction with various departments, including regulatory affairs, quality assurance, supply chain, and trade compliance.
3. Understanding the complex regulatory landscape and its impact on product design and sales, especially in the medical device industry, is crucial.
Transcript
What have you learned about this role that you wish someone had told you before you entered the industry?
I wish I'd known how central we are to every single change that happens. This applies whether it's something in the process or product development stage.
Those aspects should be run by us. So, when it comes to the actual implementation or production stage, we know how it works there.
We get to work with regulatory affairs and learn about all the changing regulations. As we try to grow our business and expand into other countries, we learn what those local regulations look like and how they impact how we structure and sell our device.
Again, working with quality, supply chain, trade, and compliance – just all these different groups. I wish I'd known how many people it really takes to get a successful product out the door.
Especially with a complicated Class III medical device product, you want everything to be in tip-top shape. Knowing how central we would be to all the conversations and how integral we are to getting that product out the door has been really cool and eye-opening.
Advizer Personal Links
linkedin.com.in/estrambe