Design Assurance Engineer (Medical Device)
Posting ID: 7372091
- Daily work includes both sustaining and project work - improving safety, quality, output and eliminating scrap and other forms of waste.
- Provide support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met. Further, monitor performance of equipment, machines and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues. Interface with Quality and Research and Development organizations to integrate new products or processes into the existing manufacturing area.
- Process validation and verification work is frequently required - knowledge of Process Validation Plans, IQ, OQ, PQ, Software validation, test method validation, gage R&R, and a clear understanding of FDA's QSR and cGMP, and a good understanding in statistics.
Qualification Requirements Skills
- Evaluate manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.
- Develop manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
- Inspection techniques including review and understanding of technical documentation and mechanical drawings.
- Knowledge of quality requirements for medical device manufacturing and requirements for inspection and testing.
- Application of risk management and principles of ISO 14971.
- Understanding of quality management systems for medical devices per ISO 13485
- Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout using principles such as Lean Manufacturing and Six Sigma methodologies.
- Assure product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes.
- Responsible for Design Control, Device Master Record & Device History Records, Standard Operating Procedures review/approval, Drawings/Specifications review/approval, Change Orders review/approval, Quality Systems Manual review and company-wide training.
- Responsible for authoring, reviewing and approving test protocols and reports for Design Verification and Validation activities
- Active participant and leadership in Design and Phase Review meetings per design control internal procedures.
- Participates in risk management activities including the development, creation and implementation of product process risk analyses, including: Design, Process and User FMEA's, product biological risk assessments and associated risk documentation per company internal risk management procedures.
- Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
- Organize and trend manufacturing data to help model cost and capacity to help plan and prioritize improvement projects.
- Training and guiding technicians and operators to execute protocols and procedures.
- Design and develop manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality.
- Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.
- Strong analytical, problem solving and project management skills.
- Demonstrated leadership capability in team settings.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Strong organizational skills, as well as attention to detail.
- Four-year technical degree required, preferably in Engineering.
- Class III, IIb Implantable Medical Device Experience is a plus
- Typical experience required is 4 plus years as an Engineer in a related field.
- Coursework in statistical analysis techniques
- Neurovascular experience is a plus
- Strong background in metals, plastics, extrusion, and/or adhesives is highly desired.
- 3D Modeling or CAD experience required (e.g. Solidworks)
- Microsoft Project, Microsoft Visio, and Microsoft Access proficiency are highly desired.
- A demonstrated ability to plan and run projects is highly desired
Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.
Recruiter: Sean Sun
Phone: (714) 347-1206