Job Description

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).

*This position will be up to 25-50% travel to Mexico*

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