Medical Devices Packaging
We are looking for experts on medical devices packaging to understand the information related to primary packaging procurement.
Please find specific questions below:
1.How is packaging supplier performance measured by medical device manufacturers?
2.Do global medical device companies have regional r&d centres for packaging?
3.Is there a sustainability engineering department in medical device manufacturers?
4.How is the burden of feedstock commodity price changes reflected?
5.Do medical device manufacturers engage with global or regional suppliers? And why?
6.What are the outsourcing strategies they adopt for tail spend?
7.Do healthcare customers value sustainability? How do they measure it?
8.What is more important for the customer- cost or sustainability? Are they willing to pay for it?
This is a ad-hoc request with time constraint and hence any quick replies are appreciated.
Thank you.+26 Other Responses
Medical 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.
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
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 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