Process engineering in a medical device manufacturing company involves more than just optimizing a process for better yield and lower inefficiencies. It includes risk management with regulatory and quality compliance on top of design controls, thus requiring multiple communication channels across numerous functional areas. This attention to detail ensures that the end product is safe and effective while cognizant of the allocated production budget and the opportunity cost of a poorly engineered process. Every stage of the process requires a deep knowledge of project management and process engineering.
So it’s no surprise that the Waddell group’s project consultants – many with a process engineering background – have worked with medical device companies across the globe to improve both processes and profits. Using a combination of lean manufacturing methodologies and the Six Sigma method, our experienced project management consultants identify and implement a clear plan and process suited to your organization’s vision and needs.
Engineering the perfect process for manufacturing new products, or introducing changes in the existing ones, is key to ensuring that a product reaches the market as early as possible while keeping the associated costs low. Poor processes cause significant rework and inefficiencies, leading to time and resource costs. Which eventually leads to a decrease in gross profit margins.
Industry Leading Project Managers Dedicated to Improving Your Process
Our project managers will seamlessly incorporate in your process:
- new or changed methods for creating product components.
- new cleaning requirements.
- assembly improvements.
- change of materials requirements (example: RoHS vs. Lead solder).
- yield improvements.
If needed, Waddell Group’s project managers will incorporate any other requirement without significant impact on the allocated budget and time frame. They’ll be able to do this while maintaining the role clarity of each member involved in the process, as well as the necessary quality and regulatory requirements.
The Waddell Group’s project managers and consultants have at least ten years of experience in the medical device industry across various specialties, including process engineering.