Jabil Staff R&D Engineer in Clinton, Massachusetts
At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 250,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world’s leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.
NP Medical , a business of Jabil, has been improving lives for over 35 years by providing products that help patients receive affordable, life-sustaining therapy. We work closely with caregivers and patients to provide innovative, distinctive products that help reduce total cost of care in the clinical setting. Our solutions are intended to reduce complications, decrease caregiver errors and accidents, and promote positive patient outcomes. We are always committed to quality patient care. Whether in a traditional setting or with emerging digital and home-based therapies, we innovate to deliver transformative product solutions.
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 development cycle to enable growth of our medical device product portfolio. Primary responsibilities of the role include assessing user needs, defining design inputs, creating alternative product solutions and product specifications, developing product design and verification testing protocols, and executing design validation studies for new device platforms. Other activities of importance include the support of regulatory filings and contributions related to 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
The Staff Engineer, with the support of team members, will be responsible and accountable for the following areas of medical device product development within the fields of fluid / medicament administration and vascular access site management:
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
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, ISO14971, CGMP and other standards as they relate to the design, manufacture, and risk assessment of medical devices
Highly proficient w.r.t. 3D CAD, 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
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