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.
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 Sr. Process Development 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.
As a Sr. Process Development Engineer on the Atia Vision team, you will be responsible for process development & optimization, verification & validation testing, and manufacturing documentation in support of product development and clinical testing in accordance with company’s Quality System.
Including but not limited to:
- Recruit and manage technicians and assemblers
- Develop mechanical aspects of manufacturing processes by applying engineering knowledge and product design, fabrication, assembly, tooling and materials
- Perform process optimization and manufacturing scale-up
- Design and validate fixtures and tools for manufacturing and inspection processes and optimize to reduce requirements for operator skill.
- Research, develop, modify, and test manufacturing equipment; perform IQ/OQ/PQ validations and gauge R&R.
- Improve manufacturing efficiency through planning and evaluation of work flow, space requirements and equipment layout.
- Provide day-to-day manufacturing support and decision-making; troubleshoot assembly process issues as necessary; respond with urgency to process and equipment issues.
- Establish and maintain manufacturing and inspection procedures; prepare process validation protocols and reports; execute process validations; collect and analyze 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 operators; assisting other technical associates.
- Design, execute, and analyze experiments using sound statistical methodology.
- Utilize required Quality System procedures; adhere to the Quality Policy and quality system requirements, including maintaining accurate documentation.
- Support product verification and validation activities by developing test protocols and writing test reports.
- 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.
- 5+ years of previous medical device experience.
- Experience with injection molding is preferred.
- 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.
- Must be proficient in SolidWorks
- Understanding and exposure to principles of product design, manufacturing, risk analysis, and product testing/reporting.
- Demonstrated ability to apply engineering fundamentals and statistical analysis to manufacturing process trending, improvement and troubleshooting.
- Familiarity with FDA QSR, ISO 13485, and the MDD.
- Excellent communication skills; ability to work independently or in project team setting.