Senior Design Engineer - Medical Devices

Senior Design/Staff Engineer

Work Flexibility: Hybrid

What you will do:

Technical Responsibilities:

• Independently research, design, develop, modify, and verify components, modules and sub-systems for medical devices. Translate user needs to design inputs/ specifications and produce complex system level designs with some guidance.

• Conduct or design advanced prototyping and testing. Analyze and correct complex product design issues using independent judgment.

Business Responsibilities:

• Advance solutions by applying in-depth knowledge of customer needs, market and competitive offerings. Apply detailed knowledge of clinical procedures to author design inputs.

• Support Voice of Customer sessions internally and with clinicians. Demonstrate developing financial acumen.

Med Device Compliance:

• Be proficient with and mentor others in usage of industry standards, including design requirements and test strategies per applicable regulations.

• Lead creation and refinement of engineering documentation, such as the Design History file. Follow and mentor others on R&D procedures like design controls and risk management, per the Quality Management System.

General Responsibilities:

• Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success. Identify and support the creation of or improvements to procedures, policies, processes, systems, and technology.

• Support and execute segments of complex multifunctional teams to advance projects through the design /development/launch process. Deliver high quality results with passion, energy and drive to meet business priorities.

Collaborate with cross-functional teams to build partnership to achieve business objectives.

What You Need:

Required Skills:

• Strong technical ability to develop and optimize designs for mechanical / electro-mechanical assemblies incorporating DFM principles. Strong technical ability in creating engineering drawings, models, applying GD&T and CAE tools

• Adept at applying knowledge of materials and manufacturing processes to product design. Ability to communicate moderate complexity plans and technical information to team members.

• Design & Development of Instruments, Implants & cases & trays as per the medical device design control. Design & Development of medical devices packaging. New product development is a must.

• Skills / Engineering tools: 5-9 years of work experience in Creo, SolidWorks. MS Project Tolerance stack up

Certifications:

• GD&T

Minimum Qualifications (Required):
• Bachelor of Science in Engineering, Mechanical Engineering or BioMedical

Travel Percentage: 10%

Experience Level

Senior Level