Job Title: Design Transfer Engineer
Location: Salt Lake City, Utah
Company Overview: Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in the design, development, and production of medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for the vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.
At Biomerics, we are dedicated to our employees, because we understand that a strong, skilled, happy workforce is the foundation of a successful business.
Job Description: The qualified Design Transfer Engineer will be responsible for the transfer of class II medical and surgical devices in a dynamic, customer focused organization. The Design Transfer Engineer will be expected to work with customers to understand product and process specifications, develop and transfer manufacturing processes, and build and test devices to those specifications. All activities will be expected to be documented according to design control requirements in a design history file (DHF).
The Design Transfer Engineer may function as an individual contributor and lead a small cross functional team comprised of engineering, operations, and quality members to provide process and manufacturability input to designs throughout the product development process. The Design Transfer Engineer will support verification, validation, and regulatory submissions of these devices, then lead the transfer of the products to production, and ensure a smooth transition to the production engineering team. The Design Transfer Engineer will work within the constraints of budget, schedule, and scope while managing risk and ensuring adherence to established processes and regulations. This Design Transfer Engineer must have experience with device design and builds for cardiovascular medical devices (catheter-based balloons, stents, Atherectomy, Thrombectomy, and Microcatheters). Must have solid experience in handle design, deflectable device design, basic electrical, medical device design practice and project lead experience.
Roles and Responsibilities Include:
Interacting with customers during the quoting and project execution processes.
Work directly with suppliers in establish material sourcing.
Demonstrating knowledge of project management principals.
Developing manufacturing processes for medical device assemblies and create associated PFMEAs.
Providing engineering services in a phased development approach to develop & launch medical devices.
Develop the manufacturing processes and flow to meet product cost targets.
Provide manufacturability input to Product Development engineers during the product development process.
Develop fixtures and assembly aids for manual and semi-auto assembly processes.
Author and execute process validation activities.
Implement continuous improvement actions in conjunction with the Production Engineering team to ramp up production of new products to meet customer demand curves and cost targets.
Bachelor's Degree in Engineering or related field (Mechanical, Biomedical, Chemical) (Required)
A minimum of 5+ years of related work experience in the medical device field (Required)
The ability to influence a team toward business objectives (Required)
Must be able to function with little or no supervision (Required)
Experience working through all aspects of medical device design & development including design verification and validation, process validation, and technology transfer (Required)
A Six Sigma Green/Black Belt (Preferred)
The ability to perform statistical analysis using k-factors, PpK, and DOEs along with root cause analysis (Required).
Proficiency in solid 3-D modeling (i.e. SolidWorks) (Preferred)
Design for manufacturability and assembly (DFMA) (Preferred)
Proficient with medical process validation, including (IQ, OQ, PQ), test method definition, root cause analysis, test method validations, measurement systems analysis (MSA), root cause analysis and structured problem solving (Required)
Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, 9 Paid Holidays, 401k, Onsite Fitness Facility
Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted).