Sr. Mechanical Design Engineer

We are looking for talented professionals to succeed and grow with us as we create the next generation of medical devices. Individuals seeking the ability to apply their talents towards unique, effective, and economical device solutions must apply. Our engineering services group values innovative and creative people who are looking for the challenges found in a diverse product portfolio. As a valued employee, you will join a dedicated team bringing the next generation of Medical Devices to market.

Summary:
Leads project-level activities in the ideation, development, design, implementation, test and transfer to manufacturing of medical devices in support of programs and organizational initiatives.
Requirements:

• Bachelor's degree in Mechanical Engineering or equivalent
• 3+ years of Leading product design and development.
• 7+ years of Direct experience with the product development process ranging from requirements development, prototyping, verification and product release. Experience in medical device design or other regulated industries
• 7+ years of leading/contributing completion of DHF document deliverables.
• 7+ years of working in development of devices in compliance to IEC 60601-1 standard
• 3+ years working under ISO 14971 Risk Management for Medical Device Standard

Strong Candidate in addition to requirements:

• 3+ years of planning, assigning, and directing work
• Responsible for appraising performance
• 3+ years in contract manufacturing environment

Essential Duties and Responsibilities

• Strong analytical and problem solving background.
• Identifies and efficiently resolves technical problems and issue.
• Leads and communicates to a client for small scale programs.
• Researches and analyzes experimental data to understand design issues and set a direction for issue resolution.
• Delegates and sets work direction for technicians and designers.
• Creates test protocols and reports for verification testing.
• Proficient in CAD (Solidworks preferred), Labview and general test and measurement equipment preferred.
• Able to complete engineering tasks in a timely fashion, and manage time budgets for tasks.
• Effectively communicates project technical status, time and schedule for tasks including estimates to complete.
• Proficient with documentation control and change order process.
• Works with suppliers and manufacturing facilities to design for manufacturability.