Job Description

Work Flexibility: Hybrid or Onsite

Designs, validates and brings new products to market. Specifies precise new product functional requirements; designs, tests and integrates components to produce final designs; and evaluates the design's overall effectiveness, cost, reliability and safety. Designs, develops, executes and evaluates fitness-for-use testing, product specifications and process validation plans; creates and reviews material part specifications and bills of materials. Collaborates with internal manufacturing partners, contract manufacturers, designers and product specialists to optimize designs for manufacturability. Utilizes CAD (Computer Aided Design) or CAE (Computer Aided Engineering) systems to model new designs and produce detailed engineering drawings.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. This position requires professional mastery of a specialized field of expertise that typically requires a college degree or equivalent. The job requires professional knowledge gained through substantial applicable work experience, to supplement formal knowledge, in order to apply principles and concepts of own subject/technical discipline in resolving issues as they arrive. The job requires good analytical skills as well as evaluative judgement based on the analysis of factual and qualitative information in complicated or novel situations. This job typically requires a degree or equivalent and a minimum of 4 or more years experience.

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.

Technical 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.
• Bachelor of Science in Engineering, Mechanical Engineering or BioMedical & 4+ years of work experience

Preferred Skills / Engineering tools:

Experience with ProEngineer or similar software is preferred.

Travel Percentage: 20%