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Staff R&D Engineer

At NP Medical, our innovation comes from the creativity and efforts of our team which is backed by a trusted network of clinicians, inventors, partner companies and suppliers. The Staff R&D Engineer provides technical leadership and hands-on contributions throughout the product lifecycle to enable both the growth and maintenance of our medical device product portfolio. Primary responsibilities of the role include user needs assessment, defining design inputs, creating and refining product concepts and product specifications, developing design verification testing protocols, and executing design validation studies. Additional activities of importance include the support of design and process improvements for existing platforms and other post-launch product engineering initiatives. The individual must have a record of success within a medical device product development environment, command of medical device design controls and related regulatory requirements, a penchant for maintaining detailed documentation throughout all phases of research and development, work effectively in cross functional teams, and collaborate in a professional manner with internal and external stakeholders.

Essential Duties And Responsibilities:

• Establishment of User Requirements and Design Inputs
• Ideation, Concept Development, and Feasibility Testing involving rigorous trade-off analysis
• Prototype Design including elements of Human Factors Engineering, Formative Usability Testing, Robust Design Analysis
• Design for Excellence w/ associated deliverables inclusive of DFMA for high-volume injection molding, automation
• Alignment with Design Controls and Regulatory Requirements
• Test Method Development
• Design Verification and Validation
• Design Platforming and Issue Resolution
• Post-launch Product Engineering and Manufacturing Support

Job Qualifications (Education, Experience, Key Requirements):

• Bachelor's degree in Engineering required; Mechanical Engineering strongly preferred
• Minimum of 7 years of medical device product development experience required; single-use disposables strongly preferred
• Proven leadership competencies
• Analytical thinker having a history of pragmatic solutions
• Strong ability to communicate technical advancements and issues to all stakeholder groups
• Must have working knowledge of FDA requirements, including 21CFR820, ISO13485, ISO14971, CGMP and other standards as they relate to the design, manufacture, and risk assessment of medical devices
• Highly proficient in SolidWorks, tolerance stack-ups, geometric dimensioning and tolerancing
• Device development experience involving common medical device polymers and related processes
• Competent using statistical analysis software; Minitab preferred

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.