Manufacturing Engineer, Atia Vision
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 and manufacturing talent interested in working in a fast paced and innovative environment.
Manufacturing Engineer, Atia Vision
Atia Vision is an early stage Shifamed Portfolio Company focused on the development of novel accommodating intraocular lens to address the unmet clinical needs the fastest growing segment of the ophthalmology market. We are currently looking for a hands-on Manufacturing Engineer who is innovative in their creative thinking, proactive in their approach to problem solving, and a collaborative team player. This position represents an exciting opportunity to join the Atia Vision team as we advance the product platform.
Including but not limited to:
- Provide day-to-day manufacturing support and decision-making; troubleshoot assembly process issues as necessary; respond with urgency to process and equipment issues.
- Develop manufacturing processes by applying engineering knowledge on product design, fabrication, assembly, tooling and materials.
- Create and maintain process documentation (DHR, MPI, QS, TM, etc.).
- Develop process optimization for efficiency and manufacturing scale-up.
- Complete equipment qualifications by performing IQ/OQ/PQ and developing appropriate equipment specifications.
- Perform gauge R&R, ATMV, VTMV on manufacturing inspections.
- Improve manufacturing efficiency through planning and evaluation of work flow, space requirements and equipment layout.
- Assure product and process quality and stability by performing process validations and process capability studies.
- Establish manufacturing and inspection procedures; prepare process validation protocols and reports; execute process validations; collect and analyse process data and trends and implement changes.
- Drive and provide support to quality processes and applying formal problem-solving techniques to determine root cause, and implementing solutions (non-conformance, CAPA, change management, audits, product complaint investigations, etc.).
- Provide training to associates, technicians and assemblers.
- Design and validate fixtures and tools for manufacturing and inspection processes.
- Design, execute, and analyse experiments using sound statistical methodology. Participate in risk management activities, including development and ownership of process FMEAs.
- Utilize required Quality System procedures; adhere to the Quality Policy and quality system requirements, including maintaining accurate documentation.
- Support company goals and objectives, policies and procedures, and regulatory requirements (FDA regulations, ISO 13485, MDD, etc.).
REQUIRED EDUCATION & WORK EXPERIENCE:
- Bachelor’s in Mechanical Engineering, Industrial Engineering or equivalent experience.
- 3-5 years of previous medical device experience, preferably in ophthalmology industry.
- Experience developing and executing process and/or equipment validations.
- Proven ability to prioritize, initiate, and drive projects to completion.
- Experience with quality system documentation requirements and test protocols.
- Demonstrated ability to apply engineering fundamentals and statistical analysis to manufacturing process trending, improvement and troubleshooting.
- Excellent communication skills; ability to work independently or in project team setting.
Please email your résumé and details to: email@example.com.