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You will be updated with latest job alerts via emailAs the Engineering Lead New Product Introduction (NPI) for Medical Devices you will play a pivotal role in launching innovative medical products into manufacturing. Youll be responsible for leading engineering efforts collaborating crossfunctionally with R&D Regulatory Quality Supply Chain and Manufacturing teams to ensure that products meet design intent regulatory standards and launch timelines. Your work will directly contribute to delivering highquality lifeenhancing medical technologies to market.
Lead NPI Projects: Own the technical of new product launches ensuring milestones are achieved on time within scope and budget.
Team Leadership & Mentorship: Guide and support a team of engineers fostering a culture of continuous improvement technical excellence and collaboration.
Crossfunctional Collaboration: Partner with R&D Quality Regulatory Manufacturing Supply Chain and Planning to align on product design process development and deployment strategies.
Product Deployment: Oversee design transfer from R&D to manufacturing including prototyping testing and process validation activities (IQ/OQ/PQ).
Risk Management: Lead DFx and FMEA efforts to mitigate technical and process risks ensuring robust design and manufacturing controls.
Regulatory & Compliance: Ensure all engineering and manufacturing processes are compliant with FDA ISO 13485 CE Mark and IEC 60601 standards.
Technical Documentation: Develop and review documentation such as DHFs risk management files validation protocols/reports and design transfer packages.
Continuous Improvement: Identify opportunities to improve engineering efficiency product quality and timetomarket through best practices and lean methodologies.
Education:
Bachelors degree in Engineering (Mechanical Electrical Biomedical or related field) required.
Masters degree preferred.
Experience:
Minimum 5 years of experience in product development with 23 years in a technical leadership or management role.
Proven track record leading NPI projects in the medical device industry with a deep understanding of the product lifecycle and regulatory landscape.
Experience in the design prototyping and validation of electromechanical and disposable/reusable medical devices.
Experience working in a regulated environment with crossfunctional teams.
Proficient in CAD tools (e.g. SolidWorks AutoCAD); familiarity with simulation and analysis tools.
Solid understanding of manufacturing processes including injection molding mechanical/PCB assembly plastic bonding adhesive dispensing laser welding and UV bonding.
Expertise in DFx methodologies (Design for Assembly Manufacturing Cost Test etc..
Strong knowledge of medical device standards including ISO 13485 FDA 21 CFR Part 820 IEC 60601.
Excellent leadership communication and mentoring skills.
Effective at presenting complex technical concepts to diverse audiences.
Skilled in project management tools and methodologies.
Strong problemsolving skills with a focus on innovation and practical solutions.
Experience with medical catheters and related bonding technologies (e.g. plastic UV laser).
Familiarity with cleanroom manufacturing environments.
Previous experience supporting regulatory audits and technical file submissions.
Benefits
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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.
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Required Experience:
Senior IC
Full-Time