Medical Device Development
We are looking for an expert in the area of medical device development, specifically for knowledge in:
plasma based therapeutic apheresis column development using antibodies/peptides
matrix/antibody coupling options and optimization
sterilization processes including aseptic technique versus end-sterilization for these devices
knowledge of regulatory issues also a plus.+10 Other Responses
Contract Sterilization Services
I am presently researching the contract sterilization services market employed for sterilizing medical devices (all classes of medical devices taken into purview and not specific to a particular device). The sterilization techniques (for medical devices) under consideration are: 1) ethylene oxide sterilization 2) gamma irradiation 3) e-beam sterilization 4)hydrogen peroxide plasma sterilization. I am looking to understand in depth, certain procurement aspects of contract sterilization services like : 1) typical contract structures and tenure of contract that such contract sterilization houses engage in with medical device companies 2) overview and components of supply chain from contract sterilization service providers perspective 3) presently employed engagement model practices 4) engagement model and contract structure best practices 5) market outlook of the contract sterilization service industry 6) negotiation or saving levers offered by the sterilization service providers 7) spend management practices adopted by contract sterilization houses 8) how are different regional markets performing in the contract sterilization services sector?+6 Other Responses
Medical Device Manufacturing Engineering
Job title: senior manufacturing engineer
job type: full - time
reports to: director of operations
location: windham, maine
are you a talented optical medical device manufacturing engineer ready to develop and execute manufacturing process plans for optics component manufacturing, continuously improve processes and plans using tools and methods such as statistical process control (spc) and design of experiments (doe), and conceptualize, design and execute tooling/process requirements? If so then read on!
- provide mfg. Engineering support of multiple projects
- manage apqp planning process for new programs
- oversee design and development of new products and processes
- conduct fmea, doe, spc analysis
- direct validation activities for new tools, process and equipment
- develop and submit validation packages for customer approval
- map work flows and develop process control plans
- train personnel to transfer new programs to production
**education and experience required**
- b.S. In mechanical engineering, optical engineering, materials science, and optical engineering, physics, chemical engineering or equivalent experience strongly desired.
- 5-8 years’ experience in engineering with experience in a manufacturing environment
- product development experience specializing in medical device and life science industry
- experience in development programs involving class ii & iii medical devices, 3d modeling,
- drafting experience using solidworks
- experience in iso13485 glp/gmp environment
- experience with design tools (solidworks, cad, 6 sigma principles and practices, fmea, statistical analysis, etc.)
- knowledge of design verification/validation activities (sterilization, biocompatibility, packaging, aging, etc.) strongly desired.
- metal stamping or medical device experience required
- minitab statistical software
- apqp process expertise
- engineering studies analysis
- map process control plans
- written work instruction level documents for manufacturing
- ability to work in a team, be proactive, and proven project management skills experience.
This is a growth position. If you are a talented optical manufacturing engineer with at least five years of experience working with lean manufacturing and medical devices, then we look forward to your resume! kindly attach your resume along with your response on zintro.
We offer: competitive salary, paid holidays, paid vacation, medical insurance, life insurance, supplemental insurance including: dental short term and long term disability, accident insurance and hospital confinement indemnity insurance, 401k with employer contribution.
Applicants must be authorized to work in the u.S.+3 Other Responses
Medical Device Prototype
Looking to design and manufacture a proof of concept alpha prototype for a medical device work with compressed air and abrasive powder for a dentalooking for subject matter expert (individual, team, or company) who can design, develop and build an alpha-prototype a device for dental surgical procedure based on our ip. The device utilizes abrasive powder under pressure in a focused controlled pattern to perform the invasive procedure in oral cavity.
The rfp will include the design and alpha prototype, manufacture of 1) a handheld operative hand piece or “working head” and 2) a controlled “pneumatic power control unit” which would include compressed air and vacuum source, abrasive powder distribution reservoir, rinse system (reservoir and pump), pressure/vacuum gauges analog or digital, regulators, control valves, control panel, fittings/tubing, electrical wiring and chassis.
Required expertise includes but not limited to
• cad design through solidworks or similar software to prepare a 3d design of the assembly and components/subassembly prints for manufacturing
• mechanical engineering, r&d, and product development experience preferably in the medical device industry.
• innovative strategist and problem solver who can develop customized, effective solutions to meet needs in challenging user requirements and mitigate procedural risk through design.
• ability to coordinates manufacturing/assembly, and testing to achieve client’s objectives on time, within budget, and to specification.
• fluidic designs: such as micro-fluidics, valves, manifolds, pumps-(e.G. Precision aspirate/dispense, diaphragm, solenoid, syringe, piston) reaction and mixing chambers, flow-cells, aspirate/dispense probes, fittings, tubing, flow calculations.
• pneumatic design: pneumatic power modules, motion/transfer devices, valves, manifolds, fittings, tubing, compressed air calculationsl procedure. Need a consulting firm who can develop a cad design, perform engineering analysis, prepare specifications of the design and source manufacturing of the alpha prototype and test the device for expected performance+16 Other Responses