Confluent Medical Technologies is seeking a Textile Process Development Engineer to design prototype medical textile-based structures and develop feasible manufacturing processes to meet customer requirements. NOTE: This is not fiber manufacture, this is textile manufacture, utilizing knitting, braiding and weaving technologies.
The ideal candidate will have previously worked as a Textile Engineer with medical device or textile manufacturing arena. Exposure to the Validation Process in conjunction with the FDA is a plus. Excellent interpersonal, organizational, and communication skills are required. The ability to fluidly shift focus between technical details and “big-picture” thinking is critical to this role.
As a uniquely qualified candidate, you will:
· Design and develop prototype medical textile based structures and processes to demonstrate feasibility for meeting customer needs.
Duties and Responsibilities:
· Works independently under the direction of the textile R&D prototype engineering manager.
- Interact with customers, medical device engineers to understand the unmet needs and offer solutions.
· Selects preliminary materials, manufacturing techniques in developing textile components and related value added processes
- Interact with outside vendors, suppliers, and consultants.
· Provide technical support to sales, customers and operations
· Assists in the selection of new technologies, equipment, and processes.
· Assists in the development of new processes and capabilities.
· Develop and execute design and process validation activities including IQ, OQ and PQ protocols, testing and reports.
- Supports the creation of risk management and design control documents – per ISO 13485 including process flow charts, PFMEA, and control plans.
Education and /or Experience
- BS or MS in Mechanical Engineering, Biomedical Engineering, Textile Engineering or equivalent.
· Minimum of 2-3 years developing textile solutions for new products with focus on front end prototype/feasibility. Ideally covering braiding, knitting, weaving, and non-woven.
- Hands on aptitude to dive in and develop prototype samples/processes to demonstrate feasibility. Must be capable of handling multiple projects/tasks at the same time.
- Have passion and enthusiasm for innovation.
o Proven problem solving skills
· Minimum of 3 years’ experience in a regulated industry. Medical device preferred.
· Experience working with bio-absorbable polymer based implantable medical devices preferred.
· Experience in the cardiovascular and/or orthopedic implantable medical device industry preferred.
· Knowledge of Design/Process Excellence (Six Sigma black belt certified is a plus) preferred.
· Under the direction of the Process Engineering Manager, be responsible for process development – from proof-of-concept prototypes to sustained manufacturing validation - planning, and coordinating engineering activities, studies and programs in support of standard production and new product development.
· Process implementation for applications such as laser cutting, laser welding, and deburring small medical components.
· CAM programming improvements using SMARTCAM and Cagila. Develop post processors and streamline HMI interfaces.
· Mechanical process developments, product selection, evaluation, and capability testing, along with selecting other equipment and tooling, reviewing and evaluating for overall effectiveness.
· Support and provide equipment guidelines and tooling modifications for process improvements.
· Be responsible for laser cutting and welding process development, including programming, motion system tuning, optimization, parameter development, troubleshooting
· Follow health, safety and environmental programs for preventative maintenance – adhering to safety protocols and ensuring that all hazards are properly managed.
· Develop strategic processing goals and objectives and integrate processes into value streams.
· Request capital appropriation based on sound testing and demonstrated feasibility.
How much should you know?
· BS degree in a relevant discipline and 3-4 or more years of related engineering experience. Or:
· MS degree and 2 or more years of related engineering experience.
You will have an edge if you . . .
· Are experienced with CAM programming and development.
· Have a mechatronics background.
· Have laser experience.
· Have solid background in SolidWorks.
· Have significant engineering expertise.
· Experience in the medical device industry.
· Experience with Nitinol.
· Possess good English communication skills – both written and oral.
Confluent offers very competitive compensation and benefits and is proud to have a distinguished reputation across Silicon Valley and throughout the medical device industry around the world! We welcome eager and ambitious team players to apply!
Confluent Medical Technologies is one of a handful of companies that design and manufacture implantable medical devices in the United States, including fabrics, stents, shunts, ports and balloons. At Confluent, we have experienced significant growth over the past 5 years and are continuing to grow. If working with a smart and creative team that designs and builds products that improve quality of life interests you, then consider a career with Confluent Medical Technologies.
Qualified candidates will be contacted. No phone, fax or email inquiries from potential applicants, external recruiters or other interested parties, please.
We regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position.
Confluent is an equal opportunity employer.
Job Type: Full-time
Pay: $70,000.00 - $115,000.00 per year
- Regulated Industry: 2 years (Preferred)
- Health insurance
- Dental insurance
- Vision insurance
- Relocation assistance
This Company Describes Its Culture as:
- Outcome-oriented -- results-focused with strong performance culture
- Team-oriented -- cooperative and collaborative