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 ResponsesMedical Devices Development
Job title: program manager
location: windham, maine
this full time job post has been authorized by zintro.
The program manager should have many years of experience around managing oem product development programs specific to the optical endoscope medical device market. Assume overall accountability for all aspects of a project and ensure success. Serve as liaison and central point of contact for client, vendors, management and engineering. Apply expertise to coordinate cross-functional project team activities, ensure timely completion of tasks and deliverables, and meet project deadlines and objectives. Advise the product engineering team on decisions regarding which deliverables are critical to the success of the project and prioritize accordingly.
Additional details of job description available upon request.
**essential knowledge, skills & abilities**
• special knowledge, skills and abilities:
• demonstrated project leadership for new product development of medical devices
• demonstrated experience working within iso 13485 and 9001
• experience managing multiple development projects simultaneously
• demonstrated experience with tools such as fmea, risk analysis, time and budget tracking, scheduling, prioritization
• excellent written and verbal skills. Must clearly communicate with team members, clients, vendors, and senior management regarding technical details and projects status
• good organizational, multi-tasking and team building skills
• demonstrated design experience in area of engineering expertise as well as broad practical knowledge of related disciplines
• strong ms project user, understand dependencies, critical path
• manage internal/external technical resources
**must have**
• bachelors degree or significant experience in a technical discipline is preferable
• minimum 8 years of product development and project engineering experience
• many years of experience around managing oem product development programs specific to the optical endoscope medical device market.
**we offer**
• competitive pay, paid holidays, paid vacations, medical insurance, life insurance, supplemental insurance including: short term and long term disability, accident insurance and hospital confinement indemnity insurance, 401k plan, direct deposit.
Please note: we are seeking to hire a full-time employee and are not interested in responses from those only interested in consulting.
This job is not eligible for visa sponsorship.
+7 Other ResponsesDesign And Prototyping Of Medical Devices
Position description: lead – ortho neuro spine
department: r&d
lead – ortho neuro spine will be responsible to develop strong talent to grow recon business that includes hips and knee, trauma, spine and navigation. Person will develop strong r&d infrastructure to manufacture, design, prototype, develop products for ortho neuro spine business. Person will also be responsible to develop strong process for development of medical device.
Key responsibilities:
• develop products and build strong teams
• to ensure having the right quality systems compliant to 21cfr820, iso13485 and iec62304
• will be responsible to hire the right talent, build a strong team and engage the team
• work closely with us r&d leaders to develop product pipelines and create product roadmap
• collaborate with sales & marketing to develop product roadmap
• work closely with support groups like ra/qa, finance and hr
• lead a team of 50 – 100 people
• to ensure timely deliverables to our internal customers
position description: lead – hospital infrastructure
department: r&d
lead – hospital infrastructure will be responsible to develop strong talent to grow hospital infrastructure business that includes patient care and handling and operating room -suite product lines. . person will develop strong r&d infrastructure to manufacture, design, prototype, develop products for hospital infrastructure business. Person will also be responsible to develop strong process for development of medical device.
Key responsibilities:
• develop products and build strong teams
• to ensure having the right quality systems compliant to 21cfr820, iso13485 and iec62304
• will be responsible to hire the right talent, build a strong team and engage the team
• work closely with us r&d leaders to develop product pipelines and create product roadmap
• collaborate with sales & marketing to develop product roadmap
• work closely with support groups like ra/qa, finance and hr
• lead a team of 50 –75 people
• to ensure timely deliverables to our internal customers
• capable of ‘thinking outside the box'
• proven experience as a project lead/ manager with good supervisory and team work skills in a fast paced/dynamic environment.
• have worked on r&d for operating room devices e.G. Surgical lights, video management, tele medicine, beds and stretchers
+3 Other ResponsesNeuromodulation Medical Devices
We are looking for insights from multiple experts from medical device companies that will help us better understand the neuromodulation space, across brain and pain therapies.
We are interested to speak with experts from the sales, strategy, marketing, and research and development sectors and in the executive, director, vice president, senior principal, and senior manager level.
This is a paid 1-hour phone interview for $250. Please provide a brief answer as to your relevance to the space below:
phase 1:
1. Please describe your role at the company.
2. How familiar are you with neuromodulation medical devices? Please explain.
3. How familiar are you with sales and/or marketing strategies for neuromodulation medical devices? Please explain.
Phase 2:
1. Please describe your role at the company.
2. How familiar are you with neuromodulation medical devices? Please explain.
3. How familiar are you with new technologies and innovations in neuromodulation medical devices?
3. How familiar are you with approaches to r&d in neuromodulation medical devices?
**please note that we are only interested in your personal point of view and are not seeking confidential information.
***referrals are highly appreciated
+83 Other ResponsesMedical 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 ResponsesMedical Device Regulatory Affairs & Quality Assurance
To plan, file, and prepare regulatory, and 510k submissions for fda on new or substantially changed products. In addition the incumbent will prepare technical files in support of ce marking, and maintain compliance with applicable device regulations including support of fda udi requirements. Finally the incumbent will serve as regulatory representative on selected project teams for new product design as well as project teams for process development, developing departmental sops/policies regarding regulatory requirements and processes.
Please note: we are seeking to hire a full-time employee and are not interested in responses from those only interested in consulting.
Competitive salary and benefits. Relocation offered.
Job responsibilities:
manage daily activities of regulatory affairs and quality assurance personnel
implement all regulatory and quality assurance activities according to in-house procedures and regulatory requirements
establish qa procedures for internal and vendor compliance with the fda and international regulatory requirements, quality regulations and guidelines
communicate with regulatory agencies; provide oversight to ensure that the company is 100% compliant with us and international regulatory requirements
lead regulatory affairs and quality assurance during fda inspections, notified body audits and internal audits; participate in all respective agency audits and responses to support audit findings or other respective actions related to such audits
determine the types of regulatory submissions or internal documentation that are required, in situations such as proposed device changes, and maintain regulatory clearances and approvals with necessary filings and communications
prepare fda premarket submissions (including fda 510k) and technical files as required for new and updated products
qualifications:
**must haves**
bachelor’s degree in a scientific or engineering field or equivalent combination of experience.
Minimum of 5 years working in the medical device industry within regulatory affairs role is required.
Must have direct, lead role fda/iso audit experience
must have proven ability to prepare and submit documents to fda, such as 510(k) premarket notifications, investigational device exemptions (ides), and premarket approval applications, (pmas); must have proven successful ce marking of devices through design dossier or technical file process.
Location: greater philadelphia area, pa
+25 Other ResponsesMedical Device Industry
Hi zintro expert,
the zintro blog needs you!
*a brief answer to the prompt about 1-2 paragraphs including your full name
*participation is voluntary no payment will be involved
*if chosen, you will be named in the post and we'll include a link to your zintro profile which will generate more visitors for you
topic and prompt
georgia tech plans to develop an incubator aimed at nurturing the next generation of medical device companies. It is part of a broader expansion by the advanced technology development center (atdc), a 30-year-old business technology incubator that has produced several atlanta tech companies including suniva, cardiomems and vendormate.
Atdc's plan includes opening multiple satellite offices in midtown, where it will focus on building startups in niches, such as microelectronics fabrication, advanced manufacturing and clean tech.
By creating industry-focused incubation space, the atdc hopes to create a cluster of like-minded startups that can feed off each other. The atdc will provide customized space, adjacent to existing georgia tech research centers, that will have special equipment, laboratories and loading docks.
What are your thoughts?
Getting your name and expert opinion published on our blog is a great marketing opportunity. If interested, please send a response to the prompt via znotes within 1-2 days. Don't forget to include your full name.
If you have any questions, please let us know.
Thank you!
the zintro blog team
wondering what the post would look like? Here is a sample:
http://blog.Zintro.Com/2014/08/14/rosetta-completes-10-year-trip-deep-space
/>
+6 Other ResponsesAutomation
This is a full-time job opportunity as a automation engineer, located in marlboro, massachusetts.
Interested candidates must attach their latest resume along with their response/cover letter over here on zintro.
***job description:
we are looking for an automation engineer with experience in development, commissioning and maintaining of automated work cells for manufacturing medical devices. This position will offer the opportunity to work with specialized equipment for high throughput medical device manufacturing in a close team-work environment with engineers, scientists and technicians.
Reports to: director, manufacturing engineering
*** key responsibilities:
- support start-up and commissioning of equipment and work cells for medical device manufacturing
- developing drawing and detailed technical documentation with specifications
- maintenance of manufacturing equipment, including plc programming, automation and trouble shooting
- integrate several pieces of equipment together under one control system/workcell
- specify equipment and suppliers capable of performing needed processes, capable within required tolerances.
- develop and execute protocols for validation of processes; installation, operational, and process qualifications.
- manage multiple projects in manufacturing environment from maintenance of existing machines to specifying, purchasing and set up of new equipment.
- work closely with cross functional teams to improve process efficiencies, product quality and reduce costs
- train and support personnel on equipment, automation and work instructions.
***education/experience requirements:
- bachelor’s degree in engineering, computer, science or related technological field
- 5+ years of relevant work experience in automation, experience in operations/manufacturing environment, preferably medical devices.
- good hands-on systems integration experience, plc and hmi programming and configuration, troubleshooting, and start-up and commissioning of work cells
- multi-disciplined engineering understanding of manufacturing, mechanical, electrical, software, etc. Engineering principles.
- good knowledge of a) plc programming proficiency b) industrial communications c) material handling and machine automation d) drive systems e) vision systems and control loops f) integration of different equipment aspects (software and hardware).
- familiar with manufacturing processes like laser welding, heat staking, engraving and plastics processing
- experience and knowledge in manufacturing products under iso 13485, and fda/cgmp/gamp software validation procedures or similar regulated environment
- exposure to or direct experience with regulated environments (i.E. Osha, epa)
- a team-oriented player who collaborates and communicates effectively in a cross-functional, multi-cultural, interdisciplinary environment
- experience in managing small to medium-sized projects.
- experience authoring and reviewing standard operating procedures, work instructions and other controlled documents.
Interested candidates must attach their latest resume along with their response/cover letter over here on zintro.
Note: this full-time job does not provide visa sponsorship.
+9 Other ResponsesMedical Device Manufacturing Engineering
Job title: senior manufacturing engineer
job type: full - time
department: engineering
reports to: director of operations
location: windham, maine
**job details**
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!
**primary function**
- 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 ResponsesMedical Device Industry
Newly established us-based medical device company is looking for an expert with in-depth knowledge of finance, marketing and preparation of business plan within medical device industry. The expert will be engaged to develop a quality business plan that is intend to be used for securing $5 million or other similar amount for initial seed funding of the company’s business model. The deliverables will include but not limited to: (1) a comprehensive business plan document; (2) a business plan financial plan that is aggressive yet realistic; (3) market data that will support the business plan; (4) necessary legal information documentation appropriate to such fundraising activity; and (5) investors presentations and briefs. The expert will be compensated upon the completion of work with shares of the company’s common stock. Please apply with skills details.
+17 Other ResponsesPennsylvania Medical Devices Engineering
Job title: senior engineer - medical devices
this full-time job post has been authorized by zintro.
Competitive salary and benefits. Relocation offered.
Senior design engineer directs, coordinates, and exercises functional authority for planning, organization, control, integration, and completion of engineering project within area of assigned responsibility by performing the following duties personally or through subordinate supervisors.
Designs, drafts layouts and drawings of medical devices, assemblies, and systems from specifications, source control drawings, sketches, models, prototypes or verbal instructions for both new and existing product design.
**confidentiality**:
this position requires strict confidentiality. The senior design engineer will be privy to sensitive company records, as well as the executive managements personal, private information. Information in these areas will not be discussed with anyone inside or outside the company. Confidentiality is a condition of continued employment. Additionally, to apply for this position, the candidate cannot have any on-going non-compete agreements.
Additional details of job description available upon request.
Qualifications:
**must haves**
- b. S. Mechanical engineering or equivalent.
- minimum of 7-10 developing medical devices and design engineering experience is required.
- excellent attention to detail and ability to multi-task.
- strong written and verbal communication skills.
- highly proficient in microsoft office programs.
- must be able to work with customers to define and document requirements, - address technical concerns and provide project status.
- ability to make technical presentations internally and to customers.
- able to work with minimal supervision, both alone and in teams.
- strong project management experience.
** desired**
- basic knowledge of anatomy and physiology
- background in medical device industry a plus.
- background in medical designs a plus.
- may assist in overseeing and assigning work to other positions.
Please note: we are seeking to hire a full-time employee and are not interested in responses from those only interested in consulting.
Competitive salary and benefits. Relocation offered.
+8 Other ResponsesMedical Devices Business Startup
Search for a ceo
a very early stage medical device start-up is looking for a ceo. This ceo should be experienced in start-ups, medical devices and funding. This person should be located in usa, preferably on east coast. Compensation is available only in shares until funding is raised.
+15 Other Responses
