Job Description

The Senior 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 Engineer will be a technical contributor and be independently responsible for project modules and deliverables. May include sustaining activity to support marketed products.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

• Designing, developing, qualifying and launching medical products utilizing a design control process.
• Executing studies in a clear, concise, and objective-oriented fashion in compliance with quality standards.
• Write, execute, and follow procedures / protocols.
• Design test methods, collect and present data using proper statistical techniques.
• Working with fellow and senior team members to achieve tasks.
• Concept, planning, and product feasibility for new products and product changes.
• Process development, validation, and verification.
• Designing products for manufacturability, cost effectiveness, and reliability.
• Assist in risk assessment activities for product and process development.
• Work with and manage suppliers/vendors for product/process development.
• Travel to visit vendors, clinicians, and to attend training.

Requirements

KNOWLEDGE, SKILLS AND ABILITIES:

• Mechanical CAD design/drafting experience, preferably SolidWorks
• Experience with Microsoft office tools such as MS-Word, Excel, PowerPoint, Outlook, etc
• 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:

• 3+ years of professional experience, preferably with medical devices.
• Experience in product design and CAD drafting, preferably SolidWorks.
• Working knowledge of ISO and FDA regulations.
• Bachelor's degree in engineering or equivalent science field.

PHYSICAL REQUIREMENTS:

• Must be able to remain in a stationary position at least 50% of the time.
• Must be able to stand for long periods of time in clinical settings.
• 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.
• Occasionally lift up to 25 pounds and transport to other offices. This may be performed with reasonable accommodation.
• View and type on computer screens for long periods of time.
• Must be able to read and manually conduct inspection processes and procedures with provided tools.

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