Job details
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
