Job DescriptionWe are seeking an entry-level Biologist to support our Product Sales and OrderProcessing team within a regulated medical device environment. This role is ideal for arecent graduate with a biology or life-science background who is interested in gaininghands-on experience in medical devices, sales operations, and customer support.Job Title: Entry Level BiologistExperience: 0-1 years of experience, experience in medical device is a plus. Location: Local candidates only (must live in Orange County)Job Type: Full Time, 100% In-HouseSalary: $20-23 DOE (Non-Exempt)Benefits: PTO, Sick days, Holiday Pay, 401k, Health-Vision-Dental Coverage, Principal Duties and Responsibilities:Responsibilities Process customer orders, quotes, and sample requests accurately and on time Support the sales team with product information, documentation, and customerinquiries Enter and maintain orders in ERP/CRM systems Coordinate with internal teams (Sales, Quality, Manufacturing, and Logistics) toensure timely order fulfillment Track order status and communicate updates to customers Assist with preparation and organization of product documentation (IFUs, productspecifications, certificates) Maintain records in compliance with FDA and ISO 13485 quality systemrequirementsQualificationsRequired: Bachelor’s degree in Biology, Biological Sciences, Biotechnology, or related field 0–1 year of experience in medical device, biotech, pharmaceutical, or regulatedlab environment (internships welcome) Strong attention to detail and organizational skills Proficiency in Microsoft Excel, Word, and Outlook Strong written and verbal communication skillsPreferred: Familiarity with FDA or ISO 13485 quality systems Experience with ERP or CRM systems Interest in sales operations, customer support, or medical devicecommercializationPhysical Requirements
- Ability to stand for extended periods
- Ability to lift up to 50 lbs
- Manual dexterity for handling small components
Lives well bridged - Indeed!
We bridge lives by offering innovative & well thought out solutions to the medical device industryWe 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.