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Mechanical Engineer II

Overview

Our client is seeking a Mechanical Engineer responsible for the design and conformance of mechanical medical device equipment and materials. The Engineer will be involved in multiple projects simultaneously, with projects at different stages, at any given time. The ME is responsible for ensuring products are safe, effective, efficient, reliable, and profitable through its intended life. The ME must meet TPH and customer expectation in regard to cost, quality and time-lines and ensures that product development is carried out in compliance with medical device quality and safety standards. This position supports New Product Development, and Production projects with oversight by the Project Manager and Lead Engineer.

Responsibilities

Investigate and procure all data required to develop a design; Troubleshoot failures and issues on all projects and support reporting requirements, Develop practical solutions for project failures and issues.

Applies standard practices and techniques as needed, adjusts and correlates data, recognizes discrepancies in results, performs root cause analysis and follows operations through a series of related detailed steps or processes. Analyze and evaluate any issues with current products to develop effective solutions.

Use resources to allocated projects efficiency, working within the budget to deliver safe and efficient products on time. Estimate the cost of projects and the time required for completion allocating resources and time effectively.

Create engineering drawings and specifications for new components, products and mechanical designs working with internal and external customers through the development and approval process.

Ensure designs abide by all regulations, policies, work procedures, safety rules, security procedures and instructions.

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Qualifications

Bachelor’s degree in Engineering.

Capable of handling complex design assignments without technical oversight.

Demonstrated track record of successful project completion/implementation.

5+ years of experience in mechanical design and support.

Familiar with advanced Mechanical Engineering concepts, practices, and procedures and significant experience in application of this knowledge to the design of products.

Familiar with 3D modeling in Solid-works software.

Knowledge of vibration, temperature and shock testing.

Familiar with GD & T practices.

Familiar with manufacturing processes and the interaction of design with the method of manufacture to be used to produce the designed item.

Able to troubleshoot complex mechanical problems, live in a customer or factory environment.

Capable of managing projects with regard to performance, schedule and cost goals.Capable of directing and reviewing the technical activities of other engineers or technicians.

Expert in the use of standard and specialized tools associated with Mechanical Engineering.

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Provide post-release manufacturing support for product improvements, documentation updates, engineering updates (ECN’s), and cost reductions.

Problems are broad, complex and abstract, often involving company-wide issues. Must develop solutions using substantial creativity, resourcefulness, innovation, initiative, negotiation and diplomacy.

Experience with Document Control – (ISO 13485, 21CFR 820.40)Design Control – (ISO 13485, 21CFR 820.30)

Risk Management – (ISO 13485, 21CFR 820.30, ISO 14971)

Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.…) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.

#LI-TS1

#CB

Job Type
Full Time
Salary
N/A
Experience
N/A
Posted
66 days ago

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