Sustaining Product Engineer

Position Summary

The Sustaining Product Engineer is responsible for the design, development, and continuous improvement of best-in-class electromechanical and optical products that provide superior visualization to healthcare professionals worldwide. This Product Engineer will drive sustaining work on our current product portfolio and add value by running new development projects that help drive cost savings. This role would require someone on site 4 days per week.

Essential Duties and Responsibilities

• Works independently with minimal guidance when applying engineering principles in the following areas of requirements: specifications; design and drafting; risk analysis; design reviews; prototyping; and design verification/validation.
• Manages sustaining engineering projects of moderate complexity to improve product safety/quality, reduce cost, address component obsolescence, or meet changing regulatory standards.
• Owns VAVE (Value Analysis/Value Engineering) metric by forecasting, executing, measuring, and reporting on VAVE projects to drive organizational cost savings.
• Designs and assembles prototypes to support product feasibility, voice-of-customer (VOC), and design verification activities.
• Manages bills of materials and drives engineering change orders.
• Collaborates with external design resources to ensure quality and performance.
• Creates test plan verifications and develops and executes test methods.
• Proactively anticipates, identifies, and mitigates product risks.
• Maintains regular communication with project teams, design partners, and management.
• Acts as a resource to junior engineers to support the team’s development.
• Provides resource estimates and commitments for engineering tasks as requested.
• Assures compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO 13485 regulatory requirements.
• Maintains in-depth knowledge of product lines and recommends improvements and/or best practices.
• Travels up to 5% domestically.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. This individual must be able to function in a fast-paced environment, where priorities may change rapidly.

Education and Experience

• Bachelor’s degree required, preferably in a related discipline (i.e. Mechanical, Electrical, or Optical Engineering).
• Minimum of 2 years of relevant work experience; product development is a plus; experience medical device or another highly regulated industry experience is a plus.

Skills and Abilities

• Strong CAD experience (i.e. SolidWorks) required.
• Experience with Product Data Management tools (e.g. Agile, MasterControl) is a plus.
• Ability to adapt to changing priorities in a fast-paced environment required.
• Ability to work independently and allocate time among several tasks required.
• Ability to solve complex problems independently required.
• Proficiency in Microsoft Office applications.
• Effective verbal and written communication skills in English required.