BridgeMed Solutions, Inc is seeking an Heart Valve Assembler. Training will be provided. Must have professional SUTURE/SEWING experience.
Are you passionate about pioneering medical innovations? Join our dynamic team at BridgeMed Solutions, where we're revolutionizing healthcare through cutting-edge technology. We are an Irvine-based Contract Manufacturing Organization this is ISO and FDA certified. We are a privately owned company that specializes in tissue heart valve technology. We additionally custom produce transcatheter valves for various clients. Embrace the opportunity to make a meaningful impact on patient care while collaborating with talented professionals in a fast-paced startup environment. Apply now and be part of our journey towards transforming lives.
Job Title: Heart Valve Assembler I, II, III, IV
Experience: We are actively seeking candidates with medical device assembly experience or a comparable background. Must have professional SUTURE/SEWING experience.
Location: Local candidates only (must live in Orange County)
Job Type: On-site, Full-time: M-F 8:30AM - 5:30PM
Pay: Starts at $20-36 per hour DOE
Benefits: PTO, Sick days, Holiday Pay, Vision-Dental-Health Coverage, Free Lunch Fridays.
Duties & Responsibilities
Duties:
Heart Valve Assembler I - Assemble production heart valves with Quality
Heart Valve Assembler II - Assemble production heart valves, cross trained on multiple different products, train new employees as needed, work with engineers on R&D design.
Heart Valve Assembler III - Assemble production heart valves, cross trained on multiple different products, train new employees as needed, work with engineers on R&D design, lead-manage-and-schedule all valve productions, responsible for completion of all production projects.
Heart Valve Assembler IV - Assemble production heart valves, cross trained on multiple different products, train new employees as needed, work with engineers on R&D design, lead-manage-and-schedule all valve productions, responsible for completion of all production projects, Including components and treatments.
Responsibilities:
- Manufacture all production Heart Valves
- Perform tissue inspection.
- Work in a cleanroom environment.
- Operate manufacturing, testing, and inspection equipment.
- Safely operate and work with equipment, fixtures, tools, and chemicals.
- Expert in interpreting GMPs or SOPs is required.
- Provide team and supervisor with status updates on assigned responsibilities and goals, and when necessary, escalate issues in a timely fashion.
- Provide feedback on any opportunities for improvement.
- Maintain compliance with Quality System procedures and company policies.
JOB REQUIREMENTS
Required Education:
- High school diploma (or equivalent), or higher education
- English proficiency
Required Skills:
- Must have professional suturing experience
- Medical device assembly is a plus.
- Must be comfortable working in a team while maintaining a professional attitude.
- Able to work under minimal supervision while observing detailed work instructions.
- Able to adapt to changes in process or routine (flexibility in workflow).
- Must be punctual and have good time management.
- Strong attention to detail.
- Effective problem-solving skills
Physical Requirements
- Able to sit or stand for up to 2 hours at a time.
- Able to lift and carry up to 25 lbs.
- Good vision: Must be able to see clearly and work under magnifying lenses and microscopes.
Lives well bridged - Indeed!
We bridge lives by offering innovative & well thought out solutions to the medical device industry
We are the leading Contract Manufacturing Organization (CMO) in the transcatheter heart valve area. We custom produce Transcatheter Aortic Valve (TAVR), Transcatheter Mitral Valve (TMVR) and Transcatheter Tricuspid Valves as per client requirements based on their IP.
We not only custom produce the valves from scratch ( tissue to valve), but also fill the gap as in-house consultants offering help in various areas like biocompatibility, ISO 22442, sterilization, viral inactivation qualification, QMS, regulatory submissions and FIH studies. Often times working with our partners we can help our clients with stent, delivery system & FIH clinical trials also.
We have the unique talent of manufacturing, consulting, and strategizing services in the area of medical devices, especially transcatheter heart valves. Our specialty is customizing the solutions required based on the device and not recommending the whole “nine yards” for any device, thus saving our clients’ time and resources.
Our talented associates work with your R&D, Regulatory, Quality, and Manufacturing divisions (or “teams”) to provide cost and time saving strategies, whether it is for simple biocompatibility testing or deep dive consulting on viral inactivation studies for class III medical devices. We come with an in-depth knowledge with many years of experience and offer customized solutions to each of our clients on an as needed basis with the utmost integrity.
Salary :
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