Senior Engineering Manager - Product Development Design Engineering
The position supports new product development by executing engineering tasks and collaborating cross functionally to bring new drug delivery systems into a production environment. Products include hand held mechanical unit dose drug delivery devices for ophthalmic, intranasal, and oral applications. This position requires a candidate with extensive product development experience in the medical device arena and will play a crucial role in the development of a rapidly growing engineering operation with responsibility for projects in engineering, design, process development, verification/validation testing, and document control.
You will be a part of the team responsible for ensuring the timely, cost responsible and ultimate successful delivery of the devices being developed. You will need excellent communication skills, project management skills and the ability to work in a corroborative atmosphere.
RESPONSIBILITIES:
Project Management
●Actively participate in all phases of the product development process, from idea creation through to transfer to manufacture
●Assist in defining product requirements, communicate and resolve technical issues, and create and present project reviews and updates
●Monitor
and report costs for design area and estimate cost affected by
design. Recommend capital expenditure and production methods for
existing or enhanced products or processes
●Effectively
collaborate with cross-functional team members comprised of quality,
manufacturing, marketing, clinical, regulatory, and materials people
to bring product from conception to production
●Develop preproduction quality assurance processes used during new product development projects and design changes to existing products
●Lead small one or two discipline project teams as needed to accomplish project objectives as well as provide supervision to technicians
●Perform Risk Analysis
Product Design
●Design plastic components for medical devices using SolidWorks, and FEA tools such as COSMOSWorks and Mold Flow
●Designs will incorporate complex mechanisms, reliability, esthetics, ergonomics, human factors, and cost
●Select sound techniques to solve problems and make recommend techniques to improve existing products/processes including recommendations of materials and process specifications
●Work with suppliers and molders in the design of injection molded components.
●Rapid prototyping, machined, and injection molded parts
●Test, analyze, and solve engineering product development problems.
●Assess designs for validity and conformance to specifications.
Documentation
●Maintain product files and other relevant documentation to comply with quality standards
●Documents design reviews, FMEA meetings, weekly meetings, and communication to suppliers.
●Maintain drawings within the Device Master Record (DMR)
●Revise drawings and documentation using the Change Control Documentation (CCD) process
●Supply Regulatory department with technical assistance for Regulatory Submissions and inquires.
Other
●Utilize engineering laboratory equipment, and assist in developing test methodologies and standards
●Design/develop fixtures to aid in assembly and production
●Perform other tasks as required
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required
●Bachelor's degree in Engineering is required
● Minimum of 12 years related experience and/or training.
●8+ years of industry experience in a medical product development and design environment
●8+ years work experience as a Design Engineer utilizing design control procedures with medical products
●6+ years experience with Solid Works including experience with surfacing techniques and advanced modeling
●5+ years Project Management experience with medical devices required
●This is a hands-on position and you must be currently and actively engaged in product development and have the ability to work effectively with small product design teams of 2 to 10 people.
●Proven project management skills and experience, including design control procedures and Medical Device regulatory procedures.
●Experience in performing FMEA’s, verifications and validations for medical devices products and processes
●Experience with products manufactured with annual volumes of 5,000 to millions
●Tolerance analysis and structural analysis using CAD and FEA software, respectively is preferred.
●Knowledge of plastics applications, associated tooling design, mold processing, and properties of plastics
●Organizes Design Reviews and follows through on their completion and communicate thoughts and ideas clearly to all constituencies
●Knowledge of manufacturing assembly, Quality Assurance, machine shop, plastics, metals, materials
●Print reading ability, ability to figure out auxiliary views, multi-view sketching or drawing;
●Metrology - ability to use calipers, micrometers, gauge pins and optical comparator.
●Hands-on experience electro-mechanical systems and formed and machined parts, a plus
●Experience with microfluidics or physical sciences, a strong plus
SOFTWARE REQUIREMENTS
●Expertise in SolidWorks is required
●COSMOSWorks, Mold Flow
●Experience with MatLab and Labview, a plus
●Fluent Computational Fluid Dynamics (CFD) experience is a plus
●Knowledge of Microsoft Office at an Intermediate or higher level
To apply for this position, please click here.Laboratory Technician II
Currently seeking a Laboratory Technician II who very hands on, mechanically adept, and used to working in a demanding and quickly changing environment.
Tasks include developing and executing test protocols and procedures. Preparing test jigs and instruments, collecting test data, and documenting test results.
The ideal candidate will be familiar with regulations applicable to medical devices and pharmaceutical device manufacturing.
RESPONSIBILITIES
●Provide technical support to research, device design, and manufacturing engineering.
●Conduct engineering tests to aid the design and development of drug delivery systems
●Contribute to the development and execution of testing protocols and procedures in support of the development of engineering designs and manufacturing processes.
●Operate production and testing equipment, instruments, tools and fixtures
●Prepare and execute equipment, test, and process validation protocols
●Collect data and document results of tests
●Communicate results coherently and effectively
●Performs additional duties as assigned by supervisor to including general maintenance of the laboratory environment in accordance with industry standards and practices
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required
●Minimum of 8 years experience as a laboratory, engineering, research or production technician.
●Minimum AA in engineering technology, science or equivalent.
●Must be hands on, very mechanically adept and a problem solver capable of thriving in a fast paced, quickly changing technical environment. Ideal candidate will have a strong background in industry or the military as a technical associate.
●Familiarity with working in a regulated industry such as consumer goods, pharmaceuticals, or medical devices is preferred as a laboratory, engineering, research or production technician. A good candidate may also come from a high technology production or technical military trade background.
●Basic understanding of test and measurement equipment is essential.
●Ability to troubleshoot and problem solve test equipment and process problems.
●Experience in operating electro-mechanical testing equipment, conducting tests, and generating experimental data.
●Experience in handling chemicals.
●Good understanding of laboratory and manufacturing safety practices.
●Basic understanding of Solidworks drawings.
●Must have competence with MS Office (Excel)
●Excellent decision making/problem solving skills
●Ability to develop and modify basic engineering drawings a plus
●Reliability and timeliness is essential
● Experience with medical products a plus
SOFTWARE REQUIREMENTS
●Microsoft, Excel, Word
●SolidWorks knowledge a plus
To apply for this position, please click here.
Electrical Engineering Technician
An emerging medical device company based in Austin, Texas is currently seeking an Engineering Technician to join our dynamic research and development team in developing the next generation of manufacturing controls for advance drug delivery production systems, and electro-mechanical device prototypes. The successful candidate will be a team player willing to meet the daily technical challenges and become an integral part of this dynamic engineering team.
Reports to: VP of Engineering
The Engineering Technician will collaborate with R&D Mechanical Engineers and Scientists in all phases of the design, development, production, testing, operation, and maintenance of drug delivery devices, mechanical equipment, tools, and industrial process machinery. This individual must have a broad range of knowledge including PC software, programming, fabrication technologies, machine operation, design concepts, electronics theory, and an understanding of scientific principles and procedures.
Responsibilities include:
-Design and create Electronic Schematics
-Design and develop Electronics Prototype controls systems
-Control Panel Design and Fabrication
-Microcontroller Programming
-PLC Ladder Logic (Unitronics Model V570)
-Linear Actuators/Servo Motor Drives
-User Interface Design & Conceptual Design
-Systems Integration
-Process Troubleshooting
-Support Prototype Device Fabrication
-Knowledge of Analog and Digital Electronics
-Temperature Controllers, Thermocouples, Cartridge Heaters
-Managing and working with vendors
-Data Acquisition
-Other Duties as Assigned
Software Requirements:
-PC Programming languages: Java, HTML, C, C++
-National Instruments LabView
Compensation:
Competitive compensation commensurate with experience