Description

JOB SUMMARY:

The Senior Principal Engineer is responsible for the design of components and assemblies for medical devices as part of the new product development team and will be involved with all phases of the product development process, from concept through commercial launch. The Senior Principal Engineer will be the owner and expert in large, fundamentally critical technologies and products/processes and be a leader for projects or substantial project sub-modules.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

Key contributor and leader to new product development projects.
Contribute to project planning, including schedule, resource needs and allocation, and budget estimates.
Design, develop, qualify and launch medical products with innovative and market changing technology.
Execute studies in a clear, concise, and objective-oriented fashion in compliance with quality standards and using proper statistical techniques.
Write, execute, and follow procedures/protocols.
Concept, planning, and product feasibility for new products and product changes.
Process development, validation, and verification.
Design products for manufacturability, cost effectiveness, and reliability.
Lead risk assessment activities for product and process development.
Key decision maker in strategic vendor partnerships for single source or specialized technical processes.
Travel to visit vendors, clinicians, and to attend training.
Manage resources effectively to accomplish project goals.
Mentor and develop the technical skills of less experienced engineers.
Facilitates difficult decision making, communicates and backs that decision.
Anticipate technical issues during development and make high level decisions to avoid them.

Requirements

KNOWLEDGE, SKILLS AND ABILITIES:

Expert CAD design/drafting experience, preferably SolidWorks.
Working knowledge of ISO And FDA regulations.
Good working knowledge of small-scale plastic/metal design and manufacturing technologies, materials and mechanism design.

EDUCATION AND EXPERIENCE:

Bachelor’s degree in mechanical or equivalent science/engineering field. Masters preferred.
12+ years of experience, preferably in medical devices.
Excellent verbal and written English communication skills.

PHYSICAL REQUIREMENTS:

Must be able to remain in a stationary position at least 50% of the time.
Occasionally move about inside the office and travel to and from office buildings to access file cabinets, employee offices, office machinery, etc. This may include, but is not limited to, bending and walking.
Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
Ability to listen and speak with employees and vendors. Must be able to exchange accurate information in these situations.
View and type on computer screens for long periods of time.

This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.