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发帖数: 101 | 1 ****申请者必须有8年以上medical device experience in ISO 13485 environment****
请直接发送简历至e********[email protected]
Principal Mechanical Engineer
Globalink Manufacturing Solutions (GMS) is a contract manufacturer that
assists clients in North American and Western European Countries with
development and manufacture of custom products and components providing
complete manufacturing solutions. A recent emphasis is being placed on
assisting more Medical Device organizations with their manufacturing needs.
Job Description
As a member of the GMS team, this engineer requires the skills and abilities
to accept and commit to multiple product/component projects that are
inclined to be within the following phases of: initial concept design,
mechanical design, design verification, product development, or currently
manufactured elsewhere and is accountable to assist to secure these projects
and technically facilitate the required needs for a successful
manufacturing launch by GMS.
Responsibilites and Duties:
• Responsible for assigned product development and manufacturing
support under ISO quality management systems and periodically working under
medical device manufacturing requirements which complies with cGMP, FDA and
other safety requirements.
• Accountable for effectively planning, coordinating and executing
all Engineering aspects for successful product/component design, development
and ongoing support for manufacturing per assigned projects and clients.
• Periodic travel required to visit external vendors, affiliate
facilities and clients domestically and internationally.
• Responsible to support projects from conception through
commercialization by engaging in all phases of design, product development
and working with an interdisciplinary team of engineers and other cross
functional team members both internal and externally sourced.
• Accountable to develop effective working relationships with
various teams and individuals in a fast paced environment and achieving
timely results are key to this position.
• Will provide technical input for influencing product/technology
road maps.
• Determine priorities and implements cost reduction projects.
• Coordinate Engineering changes relative to routings, std cost etc
. Evaluate new process technologies.
• Responsible for obtaining cost data and producing quotations for
prospective projects.
• Will initiate corrective actions where required and assist to
determine the proper and final resolution.
• Accountable for project budgets, schedules and problem resolution
for manufacturing engineering projects.
• Responsible to review client drawings and documents for clear
interpretation. Make suggestions and negotiate dimensions/tolerances and
quality constraints for ease of manufacturing.
• Other duties as assigned.
Qualifications & Requirements:
• Bachelor Science in Mechanical Engineering or related Engineering
discipline at minimum. An MS or Advanced degree or PE license is an asset.
• A minimum of 8+ years experience in mechanical product design,
development and manufacturing within the regulated Medical Device industry
is required. (OTHERS NEED NOT APPLY)
• Strong product development and manufacturing background with
working knowledge and experiences accompanying a myriad of manufacturing
processes and methodologies.
• Experience in leading multiple projects from design through
commercialization launch is required.
• Experience as a Project Manager, Team Lead, or leading cross
functional groups is required.
• Knowledge of experimentation methods and statistical techniques
is an asset.
• Working knowledge of FDA requirements for Class I, II and III
medical devices is an advantage.
• Strong analytical skills, superior written and verbal
communication skills, excellent organizational skills, and effective
interface with project teams, clients and suppliers are highly desirable.
• Demonstrated skills in process development, process documentation
, tight tolerance process development, statistical process controls, and
validations are an asset.
• Working knowledge of many materials such as: Metals, Rubbers,
Plastics and material finishes are distinctive benefits.
• Experience running self-directed projects, maintaining timelines,
owning project budgets, and seeing projects through full life cycle product
development and into production.
• Design and develop innovative, safe, robust, practical and cost
effective mechanical design solutions using CAD applications is a distinct
advantage. (Solidworks preferred)
• Highly motivated self-starter with both a "sense of urgency" for
project completion, a "sense of ownership" of resulting designs and ability
to manage multiple projects at a time.
• Must be self motivated, able to work in a team environment and
demonstrate superior ability to supervise and lead others.
• Acceptable credit to allow use of company provided credit card.
• Acceptable driving record to allow use of the company vehicle.
Salary will commensurate with Experience. |
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