job summary: Join our client's dynamic team as an NPI Engineer Lead - Medical Product, playing a key role in bringing innovative medical devices to market. Collaborate closely with cross-functional teams to drive product development from design through manufacturing, ensuring full compliance with regulatory standards. Lead technical initiatives, mentor engineering staff, and manage risk assessment, prototyping, testing, and process improvements. Candidates must have experience in medical process and product development, with specific expertise in medical devices. Experience with catheters is highly preferred! APPLY TODAY! location: SAINT PETERSBURG, Florida job type: Contract salary: $55 - 67 per hour work hours: 8am to 4pm education: Bachelors 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.Collaborate with and mentor a team of engineers, providing guidance on technical challenges, process development,and best practices. 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).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.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.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.Promote the use of best engineering practices, tools, and processes for efficient product development. Identify and implement opportunities for process optimization. Qualifcations: Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field). Master's degree preferred. 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. 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).strong leadership, mentoring, and interpersonal skills and has the ability to communicate complex technical concepts clearly to both technical and non-technical stakeholders. 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 DispensingLaser WeldingUV Bonding qualifications: Experience level: ExperiencedMinimum 5 years of experienceEducation: Bachelors (required) skills: Professional EngineerProfessional EngineerMechanicalProject ManagementPlasticsCADManufacturing Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days.