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 person 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. Qualifications:
• BS engineering degree or equivalent training and a minimum of 5 years of relevant design engineering experience
• SolidWorks and COSMOSWorks
• Aesthetic design, ergonomic design, and human factors research
• Document control procedures
• Rapid prototyping, machined, and injection molded parts
• Excellent communication skills with an ability to interface with clients
• Engineering laboratory equipment, test methodologies and standards
• Computational Fluid Dynamics (CFD) experience is a plus
To apply for this position, please click here.
Products will include hand held mechanical unit dose drug delivery devices for ophthalmic, intranasal, oral, lyophilized applications and unit dose form fill seal (primary) drug-packaging systems.
This person will play a crucial role in the development of a rapidly growing engineering operation, including primary responsibility for projects in the areas of engineering, design, process development, validation testing, and document control.
Key Responsibilities:
• Assist with the review of product development progress and evaluates results.
• Leadership responsibility on the research, development and qualification of materials, additives, and manufacturing methods for new and established products in all product categories.
• Define problems, collect data, establish facts, and draw valid conclusions then make recommendations and/or decisions based on the facts. ~Recommend necessary improvements and corrections to evaluation and qualification test specifications, technical analyses, and designs, to insure successful project completion.
• Review test reports for R&D projects to insure accuracy and correctness.
• Monitor and control assigned projects to assure compliance with approved procedures, methods, quality standards and regulations.
• Perform failure analysis and evolution of thermoplastics materials.
Qualifications:
• Bachelor of Science in Mechanical Engineering, BSME.
• 5+ years experience in design, development (R&D), and validation of medical devices with an emphasis in drug delivery a plus.
• Strong background in SolidWorks, Cosmos (FEA) and Computational Fluid Dynamics (CFD) modeling is required.
• Knowledge of the injection molding and thermoforming molding processes.
• Strong verbal, written, and presentation communications skills, ability to interface with clients and vendors, as well as experience with standard document control procedures.
• Familiarity with engineering laboratory equipment, test methodologies and standards.
•Experience with FDA quality systems in Class I, and Class II 510(k) medical devices, 21 CFR 820 (QSR), and design control is a strong plus.
The candidate will demonstrate a successful track record of hands-on involvement in delivery of technical project results in a fast-paced, creative environment with demanding schedules.
To apply for this position, please click here.
Senior Product Development Design Engineer
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.Currently seeking a Senior Mold Maker with mold design capability (MasterCAM) for a fast paced, continually improving mold shop/tool room that operates under time pressures.
Tasks include designing and fabricating complete molds, mold inserts and mold components from engineering prints and 3-D CAD models using milling, turning, grinding, sinker EDM and CNC systems.
The ideal candidate will be able to manage all machine assets, prioritize jobs based on critical factors, and assign work to team members to optimize the departments output.
RESPONSIBILITIES
●Monitor and maintain proper inventory levels for tool shop supplies and mold components.
●Train and assign work to lower level toolmakers and/or technicians. Includes the review of work performed
●Responsible for the quality of the finished work to meet the customer' satisfaction
●Work with R&D on mold making of development project including providing input into design process.
●Consult with Engineering on new projects
●Works with and exhibits an understanding of detailed 3D plastic parts design and engineering mold design
●Sound knowledge of mold design, tool steels, and plastic material, i.e., flow properties, shrink rates and processing characteristics to aid in the mold design and review process
●Ability to read interpret mold drawings and prints or CAD files and uses PC to plan sequences for timely completion of job
●Fabrication, assembly, disassembly, clean, repair, polishing molds and their components
●Perform preventative maintenance, modifications, in-press mold diagnosis, and repair for injection molds
●Understanding of mold-building process to design for manufacturability
●Program, set-up, and operate various equipment such as sinker EDM's, mill (conventional & CNC), surface grinders and lathes (conventional & CNC)
●Fabricate tools, fixtures, and components to support manufacturing and R&D.
●Plans machine operations that will continue during unattended work hours
●Perform basic repairs and preventative maintenance on equipment in tool shop
●Responsible for programming the EDM sinker machine to produce mold components, checks the electrodes for accuracy before burning, and decides the overburn of electrodes
●Performs additional duties as assigned by supervisor to include the duties of general machining and fabrication
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 15 years related experience and/or training.
●15+ years experience with injection mold tooling including mold bases and mold inserts
●15+ years experience using milling, turning and grinding equipment
●10+ years experience designing mold components including procurement of catalog components
●10+ years experience using wire and sinker EDM systems
●10+ years experience using CNC machining centers
●7+ years experience using MasterCAM and/or similar programs
●5+ years experience with molding of small precision components
●Ability to work in team environment as contributor and leader
●Experience with high quality, extremely small, and detailed injection molded parts
●Ability to read, evaluate and work from engineering drawings
●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
● Familiarity with Haas CNC Machines
SOFTWARE REQUIREMENTS
●Microsoft, Excel, Word
●SolidWorks knowledge a plus
●MasterCAM (version 9 or greater) - Required
To apply for this position, please click here.