Sr. R&D Electrical Engineer - New Product Development - Medical Devices
Sr R&D Electrical Engineer, New Product Development
Our client is a mid-sized ($500M+) medical device firm seeking a Senior Electrical Engineer with demonstrated experience developing medical electrical devices and accessories. The incumbent will work with multi-disciplinary product development teams to design, develop, and commercialize medical electrical equipment and accessories. The company will provide partial relocation assistance to the right candidate.
* Leader and major contributor to the development of hardware and software solutions and the relevant specifications, verification and validation testing for medical electrical equipment.
* Demonstrate systems capabilities by designing test methods, verifying test properties, and documenting results.
* Detailed understanding of IEC 60601-1 and IEC 60601-1-2 electrical safety and EMC compliance standards, and knowledge in designing and testing compliant systems.
* Supports the technical aspects of the product development process.
* Functions as a key contributor and core team member across functional groups to execute product development projects.
* Develops technical solutions to a wide range of complex problems that turn ideas into clinically and economically valued business solutions.
* Delivers clear communications both written and verbal in a logical and succinct manner. Can effectively present project plans and results to various management functions. Can author technical (controlled) documents; overcomes language and cultural boundaries to develop and maintain two-way communications with both internal and external manufacturers.
* Demonstrates experience in executing product changes regulated by design control; can translate customer requirements into validated market requirements and verifiable product requirements; interacts with clinicians to gain feedback on existing products and identify possible improvements.
* Develops a strong working knowledge of functional areas outside of R&D required for Product Development, Commercialization, and Sustaining Engineering, i.e. Quality, Regulatory, Product Safety, Finance, Sales, Marketing and Clinical.
* Drives decision-making efforts based on technical findings and/or threats in the marketplace; makes decisions while factoring input and perspective from team members.
* Provides leadership in developing & maintaining relationships with strategic external partners.
* Complete all work in a safe manner consistent with Company Health safety & quality protocols.
* B.S. in Electrical Engineering or Systems Engineering.
* 7 years of systems engineering experience in medical product development environment.
* Excellent written and oral communications.
* Knowledge of Quality Systems requirements for medical devices, with strong skills in Requirements Management and Risk Management.
* Ability to travel up to 25%, some international.
* Advanced degree in Electrical Engineering (M.S. or PhD.)
* Experienced in medical developments related to interventional pain.