Principal Mechanical Engineer(Onsite)

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.
2
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.
3
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.
5
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]
6
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.
7
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:

Email: Himanshu.goswami
Gtalk: Himanshu.goswamiom