Job Summary:
">
We are seeking a highly skilled Medical Device Innovation Engineer to join our team. As a key member of our product development group, you will be responsible for leading the design and development of new medical devices, manufacturing processes, equipment, and systems.
">
About the Role:
">
">
* You will lead higher-level engineering efforts to design and develop new medical devices, ensuring that they meet user needs and regulatory requirements.
">
* You will collaborate closely with cross-functional teams to deliver high-quality, original solutions.
">
* You will translate multiple inputs from Regulatory, Quality, Marketing, Human Factors, etc., into product requirements, specifications, and detailed trace matrices.
">
* You will interface with Marketing, Health Care Professionals, Customers, and suppliers to identify product opportunities, develop product solutions, solve problems, and complete projects leading up to commercialization of new and/or modifications to existing products.
">
* You will provide appropriate direction or directly lead higher-level engineering efforts to design products, processes, equipment, tooling, and components using engineering principles on a Computer-Aided Design (CAD) system and evaluating them using analysis techniques such as Finite Element Analysis (FEA).
">
* You will perform product testing, create models, and prototypes to prove out new designs and changes to existing designs.
">
* You will lead higher-level Engineering Development projects as assigned, including Problem-Solving projects to resolve issues in Manufacturing or Product Performance.
">
* You will champion Continuous Improvement of manufacturing processes and equipment through the use of Lean Manufacturing and statistical data analysis techniques.
">
* You will lead or participate in project, design, and technical reviews.
">
* You will interview, recommend, and assist in the selection of department personnel.
">
* You will troubleshoot and coordinate improvements to existing products, manufacturing processes, machine test equipment.
">
* You will support regulatory submissions and clinical trials as required.
">
* You will ensure projects are developed and documented in compliance with the Quality Management System.
">
* You will develop, approve, and revise Quality System Documents, including SOPs, Work Instructions, and Validation Protocols & Reports.
">
* You will adhere to and ensure the compliance of companies Code of Ethics, all Company policies, QMS procedures, and housekeeping standards.
">
">
Requirements:
">
">
* Bachelor of Science in Mechanical or Biomedical Engineering, Professional Engineer certification or advanced degree preferred;
">
* 6 or more years of relevant experience in an engineering field related to manufacturing;
">
* Strong analytical, technical, and problem-solving skills;
">
* Hands-on experience preferred;
">
* Effective verbal and written communication skills;
">
* Team player with good interpersonal skills;
">
* Proficient in Microsoft Office Suite, SolidWorks or equivalent modeling system, statistical analysis, and computerized analysis applications;
">
* Ability to work independently with minimal supervision as well as in a team environment;
">
* Excellent communicator with ability to run meetings and workshops;
">
* Able to travel domestically and internationally.
">
">
What We Offer:
">
">
* An exciting opportunity to work on innovative medical device projects;
">
* A collaborative and dynamic work environment;
">
* Ongoing training and professional development opportunities;
">
* A competitive compensation package.
">
">
Contact Information:
">
For further information, please contact us at [insert contact information].
">
Keyword:
">
Innovation