Job Description
:
Confluent Medical Technologies is a financially healthy and rapidly growing medical device company whose employees are passionate about providing life-saving solutions to our customers through a collaborative and high-impact work environment. Our moderate size, diversity of technologies, and broad material science capabilities provide an environment in which our employees can develop broad skill sets and directly influence product development and manufacturing outcomes.
We are looking for a Mechanical Design Engineer II to join our Warwick, RI team.
1. As a uniquely qualified candidate, you will be responsible for production planning and inventory control for multiple products while prioritizing operations to ensure maximum performance and minimum delay.
2. This individual will take a lead role in continuous improvement, product flow and capacity improvement to improve the overall efficiency of manufacturing while service level targets.
Summary:
3. As a uniquely qualified candidate, you will:
4. Design and develop sub-assembly process from feasibility through an NPD stage gate process ensuring the process is robust and transferable to manufacturing achieving performances, cost and quality targets.
5. Conduct IQ/OQ/PPQ and other activities related to the implementation of new processes and equipment.
6. Design and develop fixtures using Solidworks and CAD required to support equipment and process needs.
7. Interact with customers, medical device engineers and quality/regulatory departments. Interact with outside vendors, suppliers, and consultants.
8. Works independently under the direction of the textile process development engineering manager.
9. Participates in the creation of risk management and design control documents - per ISO 13485 including process flow charts, PFMEA, and control plans.
10. Provide technical support to sales, customers and operations Assists in the development of new processes and capabilities.
11. Work with the mechanical engineered based secondary processes development and fixture design activities related to new process development efforts for implantable textile structures for medical device applications from feasibility through optimization and validation to transfer to production.
Education and Experience:
12. BS in Mechanical Engineering, Bio Medical Engineering or equivalent.
13. Minimum of 3-5 years of experience in Engineering with process development and fixture design.
14. Familiarity with Solidworks and CAD systems.
15. Green belt six sigma preferred.
16. Some medical device design and development experience preferred.
17. Some direct experience with Knitting, Weaving, Braiding or Non-woven product development preferred.
18. Must be capable of handling multiple projects/tasks at the same time.
19. Hands on aptitude to dive in and develop processes that are robust and transferable to manufacturing.
20. Must be capable of handling multiple projects/tasks at the same time.
21. Have passion and enthusiasm for developing new products & processes.
22. Proven problem solving skills
23. 1 year experience in a regulated industry. Medical device preferred.
Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.
We regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position.
Confluent Medical Technologies is an equal opportunity employer.
Only qualified candidates will be contacted.