Sustaining Engineer

Company

Ori Gen Biomedical, Inc., is a global leader in cryopreservation and cell culture. We collaborate with top researchers, clinicians, and business partners to enhance solutions, improve patient outcomes, and achieve customer satisfaction by providing safe and effective products that positively impact the quality of life.

The Sustaining Engineer will support on‑market Class I and Class II disposable, sterile medical devices with technical support, product training, improved processes, contingency planning, revalidation testing, and implementation of cost savings initiatives. The sustaining engineer will assist both manufacturing and development engineers to maintain our on‑market devices.

• Draft and execute test protocols to demonstrate product capabilities that meet customer needs.
• Manage the design history files of on‑market devices and keep to state‑of‑the‑art standards.
• Prepare and lead design reviews for design changes.
• Support verification and validation planning activities for on‑market devices, including supplier‑initiated changes, material changes, design changes, etc.
• Plan and execute continuous improvement activities focused on quality improvement and cost reduction.
• Consult with marketing and regulatory to identify new markets for devices and plan new validation and testing activities as necessary.
• Assess risk to the design, manufacturing process, and use of on‑market devices.
• Execute risk mitigation activities to reduce risk to patients as far as possible and document to current standards.
• Perform Root Cause Analysis of product‑related problems, plan, and implement corrective actions.
• Assist in complaint and discrepant material investigations with good documentation and reporting.
• Create supply‑chain contingency plans for critical raw material components of on‑market devices.
• Assist Development Engineering with variant development projects of on‑market devices including preparation of cost estimations, drawings, and samples.
• Provide product technical support to account managers and customer service.
• Train manufacturing technicians and quality inspectors to the use of products.
• Establish and maintain standards for released drawings and material specifications.
• Review revisions to Standard Operating Procedures and manufacturing instructions.
• Evaluate and document process risks that tie into validation.
• Other duties and/or projects as assigned.

• Knowledge of FDA regulations and GMP guidelines for medical device process validation.
• Proven skills in coordinating and managing day‑to‑day tasks and working in collaboration to accomplish deadlines and objectives.
• Proficiency in technical and layman writing.
• Works in cross‑functional teams to complete projects and testing.
• Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel.
• Proficient in computer‑aided design (CAD), preferably Solid Works, and statistical analysis software, preferably Excel and Minitab.
• Outstanding communication skills, both written and oral, and will be expected to communicate directly with production management, production technicians, engineers, and senior management.

• Self‑motivated
• Broad creativity and curiosity
• Ethical Conduct
• Communication and interpersonal skills
• Strategic Thought
• DOE and Validation testing
• Corrective and preventative actions
• Computer‑aided design (CAD)
• Statistical analysis
• Bachelor’s degree in Engineering OR Bachelor’s degree in STEM and 4+ years’ experience in engineering principals of medical devices / ISO 13485 environment
• 3+ years of applicable experience in sustaining, development, or design engineering
• Demonstrated ability to use effective and results‑oriented problem solving and critical thinking skills; strong troubleshoot ability
• Strong interpersonal and people skills
• Strong organization and time management skills with the demonstrated ability to meet deadlines
• Strong and effective communication skills (verbal and written)
• Ability to work independently and lead or participate in a cross‑functional team environment

• ISO 13485 experience, specifically design…