Principal Mechanical Engineer(Onsite) Location : Raleigh, North Carolina

Principal Mechanical Engineer(Onsite)

Location : Raleigh, North Carolina

Interview : Phone+Skype

Job Description : Technical Lead

Technical leadership of system features and functions

as applicable to a medical device. Expectation is this

leadership requires collaboration and leading of other

engineering groups.

Mechanical Engineering

Take leadership of projects in development, managing

all team members assigned to projects to keep them

moving forward on schedule.

Provide engineering analysis, feasibility reports and

studies to assist advanced development projects.

Provide broad mechanical engineering technical

expertise through various phases of product life cycle.

Innovation

Develop, design, and test innovative concepts and

solutions which align with the needs of the clinic,

patient and business.

Collaborating with the engineering and marketing

department on product feasibility.

Provide mechanical engineering subject matter

expertise in designing and building test setups and

fixtures for various Advanced Development projects.

4 Documentation Maintain accurate documentation throughout the design

process per GDP and GMP.

Write product requirements and specifications to

support feature.

Plan, design, execute and report on system

experiments as related to feature development and the

product roadmap.

Test Methods

Prove product design by developing test plans,

adjusting design, running performance calculations,

maintaining quality standards and approve prototypes.

Validation of the test tool or setup is usually required.

Job Description | Global [Enter Division]

Prototype manufacturing

Lead engineering prototype builds, including generating

BOMs, ordering parts and materials, and training lab

technicians.

Work closely with pilot manufacturing line and

operations group to develop a device build process.

Good laboratory practice

proficiency.

Complete knowledge in operating critical lab equipment

such as oscilloscope, microscope, acoustic tank, force

balance, translation stage, impedance analyzer, pulse-

echo fixture, cryostats, and training others.

Experience testing PCBA and soldering parts.

Essential Skills

Lead Self Lead Others

Time Management

Digital Acumen

Problem Solving

Emotional Intelligence

Resiliency

Communication

Leadership

Collaboration

Project Management

Motivate & Influence

Technical & Functional Skills

Thorough understanding of test method validation, GR&R, GD&T, and statistical analysis

Solidworks or other CAD experience

Understanding and application of ISO Quality System requirements and FDA regulations for

medical device manufacturing

Familiar with a variety of manufacturing processes including mechanical and electromechanical

Minimum Qualifications

Bachelor s Degree in ME, IE or EE or other relevant Engineering discipline

10+ years of related design and manufacturing experience in the medical device and / or

component development industry

Design Control experience including design and process verification and validation.

Experience in manufacturing and assembly process development and validation (IQ, OQ, PQ)

Injection molding, die casting, metal stamping and / or machining knowledge, including

fixtures gauges and tooling experience

Preferred Qualifications

Practical knowledge of Six Sigma methodologies or SPC. Green or Black Belt certification

Familiar with project management methods and tools

Travel Requirements

Up to 20%

Physical Requirements

This position requires you to sit, stand and perform general office functions. You may also be required to

lift up to twenty-five pounds occasionally. Bending, stooping and reaching are also frequently required.

Equal Employment Opportunity

It is our policy to provide equal employment opportunity for all applicants and colleagues. This policy

includes our commitment to ensure that all employment decisions are made without regard to race, color,

religion, gender, national origin, disability, pregnancy, veteran status (including Vietnam era veterans),

age, sexual orientation, gender identity, or any other non-job-related characteristic protected by law

Himanshu Goswami

Sr. IT Technical Recruiter

Stellent IT

Phone

3217856032

Email : Himanshu.goswami

@stellentit.com

Gtalk : Himanshu.goswami

@stellentit.c

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