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#1. Product Development Engineer
The Product Development Engineer performs technical activities of assigned
projects to ensure medical device is in compliance with applicable
regulatory requirements and quality control standards. Develops
specifications and requirements for new product introductions. Plans,
schedules, conducts, and coordinates design control activities. Prepares
and reviews engineering documentation and performs a variety of complicated
tasks requiring a wide degree of creativity and latitude.
PRIMARY DUTIES & RESPONSIBILITIES:
Create test protocols and perform product development and verification
testing.
Write high quality engineering test reports and engineering justifications.
Work with regulatory affairs (RA) and design assurance (DA) to ensure
delivery of protocols and reports that meet RA/DA requirements.
Update and maintain product specifications and other controlled documents.
Develop new methods of testing, training technicians and lab workers.
Support production and quality for product issues and engineering changes.
Analyze materials and data, troubleshooting, monitoring performance,
insuring quality control and creating documentation.
Manage biocompatibility and product stability testing, including and not
limited to managing an outside vendor to conduct testing and/or testing in-
house.
Work with Operations, Manufacturing, Quality and other parties to set up new
processes in support of new product development.
Attend appropriate meetings – technical and core team, providing updates as
required.
Stay up-to-date on industry standards, government regulations and new
developments in the FDA regulated medical device field.
REQUIREMENTS:
Master’s degree or Bachelor’s degree with 2+ years related experience and
background in Materials Science, Chemical Engineering or related disciplines.
Possesses strong technical understanding in materials science & analytical
chemistry.
PREFERRED QUALIFICATIONS:
Experience in R&D medical device, dental or FDA regulated industry is a plus.
Experience with 3D CAD, Solidworks or other design software is a plus.
Preferred experience with FDA design controls especially around Design
Validation and Design Verification.
Excellent communication skills (Technical, Oral, Written) and experience
leading projects in a team environment.
Proficient with Microsoft Word, Excel and Project is required.
#2.Sr. R&D Engineer
The Sr. R&D Engineer will plan and execute on engineering assignments for
new product designs, exercising good judgment and originality, as well as
technical expertise. This requires an understanding of clinical practice
and technique, knowledge of products currently in use and understanding of
applicable manufacturing methods.
PRIMARY DUTIES & RESPONSIBILITIES:
Support all initiatives related to the development of new hardware and
material technologies and concepts.
Provide technical leadership and project management over complex design and
development projects for dental devices.
Lead R&D collaboration projects with cross-functional team members and
outside research partners. Travel for collaborations if needed.
Create drawings and realize design and fabrication of lab testing equipment.
Perform researches and product development through design of experiments.
Perform technical assessment through reviewing literatures and patents.
Develop and design product features and part geometry.
Test, analyze and select optimum designs and manufacturing techniques.
Develop product performance specification requirements and design acceptance
criteria.
Analyze and develop potential manufacturing processes and procurement
specifications.
Manage the manufacturing of prototypes and proof-of-concept parts.
Manage competitive product analysis and testing.
Support the development of applicable regulatory documentation and
engineering activities related to medical device compliance.
REQUIREMENTS:
PhD Degree in Mechanical Engineering, Chemical Engineering or related
disciplines AND 2+ years of relevant experience OR
MS Degree in Mechanical engineering, Chemical engineering or related
disciplines AND 5+ years of R&D experience including:
Product development experience in Medical devices and knowledge of Design
Controls is required.
CAD skills are required, both in 3D modeling and 2D engineering prints.
SolidWorks experience is a plus.
Experience managing projects is required.
PREFERRED QUALIFICATIONS:
Demonstrated leadership and communication skills are required, as the
candidate will lead project development teams.
Ability to work well under pressure and able to utilize problem solving
techniques effectively is critical.
Ability to evaluate, prioritize and manage multiple activities is critical.
Strong attention to detail, organization and the ability to create clear and
effective documentation is critical.
Ability to effectively interface with cross-functional team members,
customers, clinical consultants, outside research partners, and vendors.
Strong problem-solving capabilities to solve practical problems; and deal
with a variety of concrete variables in situations where only limited
standardization exists; and to interpret a variety of instructions furnished
in written, oral, diagram, or schedule form.
Statistical skills are required to work with mathematical concepts such as
probability and statistical inference, and to apply concepts such as
fractions, percentages, ratios, and proportions to practical situations. |
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