Senior R&D Engineer, Catheters
About our Company
Founded in 2015, M4D LLC is a premier design, developer, and manufacturer of neurovascular medical device technologies. Our mission is to improve and save people’s lives by innovating and integrating medical device technologies into marketable therapies. We are passionate about our commitment to manufacturing quality products and proud about our contributions to the healthcare community. Our ability to work creatively and swiftly allows us to continuously innovate and deliver on our mission!
If you are someone looking to make an impact on people’s lives, passionate about being innovative, and want to partner with outstanding talent, we would like for you to join us! You would be an excellent fit if you are a self-starter, result-driven, adaptable, highly organized, innovative thinker, enjoy collaboration, and solutions oriented.
Summary of Position
We are hiring a Senior R&D Engineer to join our team and play a critical role in designing and developing new access products.
This is a permanent, on-site, full-time position based at M4D LLC, Lake Forest, CA.
Prior experience working with neurovascular catheter (especially balloon catheters) is not necessary but highly advantageous.
This position will report directly to the R&D Manager. Specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and product development needs.
Responsibilities
• Provide technical leadership for the design and development of medical devices
• Assist in the transfer of new products from R&D to production
• Establish processes and manufacturing documentation for new catheter products
• Identify processes/materials to fabricate new products
• Use CAD software (Solidworks preferred) for part and assembly design and detail drawings
• Perform experiments to determine validity of designs
• Provide technical leadership for development projects
• Define product requirements
• Design and development of tooling
• Perform or manage design verification, equipment qualification and product and process validations
• Prepare and maintain product documentation including DHF, drawings, BOM, test protocols and reports, DCOs, etc.
• Supervise and advise team members and technicians as necessary
• Comply with applicable FDA and international regulatory laws/standards • Work directly with physicians to determine design inputs and/or design changes
• Other duties as assigned or required
Qualifications
• Bachelor’s Degree in mechanical or biomedical engineering or equivalent experience.
• 3-10 years industry experience with a medical device company
• Demonstration of excellent communication (written and oral) skills
• Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
• Prior experience with non-invasive medical devices (catheters).
• Ability to present/teach detailed technical information, to all levels of company personnel and customers
Pay Range
$100k to $130k
Interested in applying? Fill out the attached application and attach with your resume.