Job Description
Sustaining Engineer OriGen Biomedical - 4.2 Austin, TX Job Details 22 hours ago Qualifications Developing medical devices Project team coordination Microsoft Excel ISO standards Technical writing within manufacturing CAD design (engineering design task) Collaboration with product development teams Design engineering Leading team collaboration initiatives Product design Quality standards in production Collaboration with manufacturing teams Engineering product development Design controls Biomedical regulatory compliance Productivity software Cross-functional team management Cross-functional communication FDA regulations Data analysis software Full 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 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. 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. 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 REQUIRED SKILLSETS
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 SolidWorks, 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. COMPETENCIES
Self-motivated Broad creativity and curiosity Problem-solving skills, including fish-bone diagrams, 5-whys, FEMA Project Management Ethical Conduct Communication and interpersonal skills Strategic Thought Adaptability DOE and Validation testing Decision making Corrective and preventative actions Computer-aided design (CAD) Statistical analysis MINIMUM QUALIFICATIONS
(KNOWLEDGE, SKILLS, & ABILITIES) 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) Close attention to detail Ability to work independently and lead or participate in a cross-functional team environment PREFERRED QUALIFICATIONS ISO 13485
experience, specifically design control Knowledge of EU Medical Device Regulation (MDR) 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 wear personal 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.
