At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe. Position Summary: We are seeking a highly skilled and experienced Engineering Lead to join our dynamic New Product Introduction (NPI) team for medical devices. This role will be responsible for collaborating with cross-functional teams in the introduction of innovative medical products to manufacturing, ensuring adherence to regulatory standards, quality requirements, and project timelines. The ideal candidate will have a strong background in engineering (mechanical, electrical, catheter, or biomedical), with significant experience in NPI for medical devices. You will lead the engineering efforts, collaborate with R&D, regulatory, manufacturing, planning and procurement, and quality teams, and drive product launch to manufacturing. Key Responsibilities: + Lead NPI Projects: Own and drive the technical aspects of the product launch process, ensuring that engineering milestones are met within scope, schedule, and budget. Provide leadership across all stages of product introduction. + Team Leadership & Mentorship: Collaborate with and mentor a team of engineers, providing guidance on technical challenges, process development, and best practices. Foster a culture of innovation and continuous improvement. + Cross-functional Collaboration: Work closely with R&D, regulatory, quality, supply chain, and manufacturing teams to ensure seamless integration of engineering requirements across all functions. + Product Deployment: Collaborate with the design, prototyping, and testing, and manufacturing launch of new medical devices, ensuring compliance with industry standards (e.g., ISO 13485, FDA regulations, IEC 60601). + Risk Management: Identify potential engineering risks early in the development and deployment process and implement mitigation plans. Lead failure mode and effects analysis (FMEA) and ensure design and manufacturing controls are followed. Direct and participate in DFx activities. + Regulatory & Compliance: Be familiar with medical compliance processes (IQ, OQ, PQ, etc.) Ensure all engineering deliverables and documentation are in compliance with relevant medical device regulations (FDA, ISO, CE). Support regulatory submissions and audits. + Technical Documentation: Develop and review technical documentation required for product approval, manufacturing, and post-market support, including design history files (DHF), risk management files, and validation reports. + Continuous Improvement: Promote the use of best engineering practices, tools, and processes for efficient product development. Identify and implement opportunities for process optimization. Qualifications: + Education: Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related field). Master’s degree preferred. + Experience: + 5+ years of experience in product development, with at least 2-3 years in a leadership or management role. + Proven experience leading NPI projects for medical devices, with a strong understanding of the development lifecycle and regulatory requirements. + Hands-on experience with design, prototyping, and testing of medical products (electromechanical, reusable and single use devices). + Experience in cross-functional teams, driving product design, development, and manufacturing in a regulated environment. + Technical Skills: + Familiarity in CAD (e.g., SolidWorks, AutoCAD) and simulation tools. + Strong understanding of manufacturing processes (e.g., injection molding, PCB design and assembly, mechanical assembly). + Strong understanding of DFx principles and practices. + Familiarity with medical device standards (ISO 13485, IEC 60601, FDA 21 CFR Part 820). + Leadership & Communication: + Strong leadership, mentoring, and interpersonal skills. + Ability to communicate complex technical concepts clearly to both technical and non-technical stakeholders. + Experience with project management tools. + Problem-Solving & Decision-Making: Strong analytical and troubleshooting skills, with a focus on finding innovative solutions to engineering challenges. + Travel + Ability and availability to travel 50% in order to support on-site product launch activities. + + Preferred Skills + Medical Catheters + Plastic Bonding + Adhesive Dispensing + Laser Welding + UV Bonding BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in. 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. Accessibility Accommodation If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com or calling 727-803-7988 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to. #whereyoubelong #AWorldofPossibilities