Product Development Engineer

Genius Talent has partnered with a leading Med Tech Company that is in search of a Product Development Engineer. Reporting to Product Development leadership, the Product Development Engineer is responsible for leading the execution of medical device development projects to completion as well as managing and mentoring technical resources. The role delivers technical execution and managerial guidance, as well as independent technical deliverables necessary to facilitate the achievement of project milestones. We currently have openings for this position in Minneapolis, MN and Providence, RI. The role of the Product Development Engineer requires a well-rounded individual with the following skills:

• Technical management skill stemming from independent expertise in an engineering discipline (e.g., Mechanical, Electrical, Software, Biomedical).
• Systems Engineering for Medical Device development (i.e., experience authoring/creating and/or leading the authoring/creating of systems documentation that is essential to defining the requirements of a medical device product).
• Design Verification and Validation (i.e., experience defining/executing/leading V&V activities for medical devices essential to release of a medical device product).
• Process Validation, project management and client communication skills.

Responsibilities

• Lead the execution of medical device product development projects, and resources thereof, through all phases of development according to the project plan/contract.
• Drives execution of development strategies that successfully fulfill complex design specifications as well as medical device quality and regulatory (FDA & EU) requirements according to the scope of project contract.
• Lead multidiscipline technical teams through the process of designing and developing electro-mechanical medical devices with a high degree of competence and experience.
• Effectively communicate and collaborate with internal and external subject matter experts (SMEs) to facilitate proper (i.e., technically sound) execution of programmatic deliverables.
• Communicate product development status (technical and otherwise) and elevate programmatic issues to appropriate Director of Product Development.

Requirements

• Excellent verbal and written communication skills among clients, colleagues, and senior leaders.
• Strong presentation and interpersonal skills.
• Ability to lead technical teams/programs through the following development phases:
• Specification Development (i.e., Design Inputs)
• Design & Engineering Development (i.e., Design Outputs)
• Design Verification
• Design Validation
• Process Validation
• Manufacturing Transfer
• Ability to lead proper execution and/or utilization of the following documentation:
• Use Failure Modes and Effects (UFMEA)
• Design Failure Modes and Effects (DFMEA)
• System Design Specification (SDS)
• Trace Matrix (TMX)
• Ability to independently execute tasks associated with the design of electro-mechanical medical devices with a high degree of competence and experience (i.e., able to independently contribute consistent with candidate s area of formal education to technical deliverables). Note that the intent of the Product Development Engineering role is to lead execution of tasks. However, independent execution of tasks by the Product Development Engineer may be necessary, dependent upon each program s individual needs.
• Ability to apply medical device product development expertise towards satisfying the rigors and requirements of Design Verification and Validation of complex electro-mechanical devices. To this end, familiarity with the following standards, which are integral to the development and verification of many medical device products, is necessary:
• FDA QSR: 21 CFR 820 Medical Device Quality System Regulation
• ISO 13485 Medical Device Quality System Management
• ISO 14971 Medical Device Application of Risk Management
• ISO 10993 Biological Evaluation of Medical Devices
• ISO 11607 Packaging for Terminal Sterilized Medical Devices
• IEC 60601 Medical Equipment Basic Safety & Essential Performance
• IEC 62366 Application of Usability Engineering to Medical Devices
• IEC 62304 Medical Device Software Life Cycle

Education & Professional Experience:

• Minimum of a Bachelor's degree in an engineering discipline from an accredited College/University (e.g., Product Design, Mechanical, Electrical, Biomedical).
• Skills consistent with at least three (3) years of experience as an individual technical executor (i.e., engineer) with regard to the design of electro-mechanical medical devices.