ABOUT SHIFAMED
Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical technology incubator focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
As Shifamed's portfolio of companies continues to expand, we are looking for creative medical device engineering talent interested in working in a fast paced and innovative environment.
Myra Vision is an early stage Shifamed portfolio company developing a next-generation intra-ocular device. We are currently looking for a hands-on, entry-level R&D engineer who is a creative thinker, problem-solver, and a collaborative team player. This position represents an exciting opportunity to join the Myra Vision team in its early stage and help us develop a product from proof of concept to being ready for clinical use.
POSITION DESCRIPTION:
Myra Vision is a Shifamed Portfolio Company focused on the development of a next-generation minimally invasive glaucoma surgery (MIGS) device. We are currently looking for a Sr. Process Development Engineer. This position represents an exciting opportunity to join the Myra team at an early stage where you will creatively design and develop processes involving both an implant and a delivery system. As a Sr. Process Development Engineer on the Myra team, you will be responsible for hands-on design, development, and manufacturability of the company’s products including specific products, subsystems, and components. You will be directly involved in development and problem-solving in a wide range of areas including assembly handling methods, component manufacturing, process optimization, equipment selection and operation and verification & validation activities.
Given that many of the essential functions of this role must be provided on site or in person, this role requires full COVID-19 vaccination (subject to any exemptions or accommodations due to medical or religious reasons).
POSITION RESPONSIBILITIES:
Including but not limited to:
Provide creative solutions to satisfy unmet clinical needs through creation of innovative processes and methods of manufacture
Work as part of a cross-functional team to develop, optimize, verify, and validate processes through bench, in-vitro, and in-vivo testing
Develop appropriate methods of manufacture during iterative design development, verification and validation testing
Effectively document work throughout the development process inclusive of lab notebooks, design reviews, Manufacturing Process Instructions (MPIs), equipment qualifications, and process validation
Develop new manufacturing processes as needed, refine the process (through DOE and other methodologies) and implement the process into the production setting
Select and manage critical suppliers and vendors
Provide technical support for regulatory/clinical, marketing, and/or sales efforts
Guide and mentor other less experienced team members
REQUIRED SKILLS & HANDS-ON EXPERIENCE:
Design for manufacturing
Creative micro or nano scale engineering problem solving and process development
Micromachining and microfabrication processes for metals and polymers
Design and fabrication of assembly fixtures
Process development on both a prototype and manufacturing level
Lab and cleanroom environment
Excellent communication skills; ability to work independently or in project team setting
PREFERRED SKILLS & HANDS-ON EXPERIENCE:
Nitinol material properties and processing
Development of ophthalmology products
Micro and/or nano scale assembly
Process ownership from concept to commercialization
Semi-conductor fabrication and processing
Tool and fixture design on SolidWorks or equivalent
REQUIRED EDUCATION & WORK EXPERIENCE:
Bachelor's or Master’s Degree in Engineering
5+ years of medical device industry experience.
Previous experience working with medical device development
Experience working under quality systems designed to meet governmental regulations
Ability to work independently or in team setting required