Sustaining Engineer I

OriGen Biomedical; Austin (TX); On-site; USD 75,000 - 95,000; Full time

Job summary

OriGen Biomedical, Inc. is seeking a Sustaining Engineer I to support on-market Class I/II devices with technical support and training. You will assist manufacturing and development engineers, improve processes, plan validations, and implement cost-saving initiatives.

The role emphasizes risk assessment, documentation, and cross-functional teamwork to ensure device reliability and regulatory compliance. This position involves hands-on support in a regulated environment and may require

Qualifications

• Knowledge of FDA regulations and GMP guidelines for medical device validation.
• Proven skills in coordinating and managing day-to-day tasks and meeting deadlines.
• Proficiency in technical and layman writing.

Responsibilities

• Draft and execute test protocols to demonstrate product capabilities.
• Manage design history files for on-market devices and maintain standards.
• Collaborate with marketing and regulatory to identify new markets and plan validation activities.
• Assess risk to design, manufacturing, and use of on-market devices.
• Perform root cause analysis of product-related problems and drive corrective actions.
• Create supply-chain contingency plans for critical raw materials.

Skills

FDA regulations

GMP guidelines

Technical writing

Cross-functional teamwork

Communication

CAD

Excel

Word

Project management

Education

Bachelor’s degree in Engineering or 4+ years in medical devices/ISO 13485

Tools

CAD (SolidWorks)

Microsoft Word

Microsoft Excel

Job description

COMPANY

OriGen 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.

POSITION SUMMARY

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

ESSENTIAL DUTIES AND RESPONSIBILITIES

• The essential duties and responsibilities of this position include, but are not limited to the following:
• 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.
• 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.
• 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.
• Perform Root Cause Analysis of product‑related problems, plan and implement corrective actions.
• Other duties and/or projects as assigned

REQUIRED SKILLSETS

Knowledge of FDA regulations and GMP guidelines for medical device 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, CAD, and Excel. Outstanding communication skills, both written and oral, and will be expected to communicate directly with production management, production technicians, engineers and senior management.

COMPETENCIES

• Self‑motivated
• Broad creativity and curiosity
• Problem‑solving skills
• Computer Aided Design software (e.g. SolidWorks)
• Project Management
• Ethical Conduct
• Communication and interpersonal skills
• Strategic Thought
• DOE and Validation testing
• Decision making
• Corrective and preventative actions
• Bachelor’s degree in Engineering OR 4+ years’ experience in engineering principals of medical devices /ISO 13485 environment
• 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

PREFERRED QUALIFICATIONS

• ISO 13485 experience

SUPERVISORY RESPONSIBILITY

This position has no supervisory responsibilities. This position may be required to lead/report on projects and ensure participants meet deadlines.

WORK ENVIRONMENT

This job operates in a climate‑controlled warehouse and/or professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. The noise level in the work environment is generally moderate however periods of higher‑level noise may occur. This job may also operate in a cleanroom environment. The cleanroom environment requires personnel to wearpersonal clothing completely covering the legs; company‑provided cleanroom attire; e.g. coat, bouffant, face mask, and gloves.

• Must be able to stand or sit for extended periods. Must be able to wear personal protective equipment when required

PHYSICAL DEMANDS & WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently required to stand, walk, climb, sit, stoop, bend, and reach with hands and arms. The employee must frequently lift and/or move up to 50 pounds and may be required to operate automated warehouse equipment; e.g. electric pallet jack, or forklift. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.