Product Development Engineer

**Summary** The Product Development Engineer is responsible for the design, development, testing, and commercialization of innovative products throughout the entire product lifecycle. This role translates customer and user needs into engineered solutions while ensuring compliance with FDA regulations, ISO standards, and internal quality system requirements. The engineer collaborates with cross-functional teams to develop product requirements, executes verification and validation activities, maintains design documentation, and solve complex technical challenges. Additionally, this position supports the identification, protection, and management of intellectual property through invention disclosures, patent documentation, and patentability assessments. Success in this role requires strong technical expertise, project management skills, effective communication, and a commitment to delivering safe, high-quality products that meet customer and business objectives. **Essential Duties & Responsibilities** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. - Design, develop, and sustain products in accordance with business objectives, customer requirements, and applicable regulatory standards. - Translate user needs into design inputs, engineering specifications, and product requirements. - Execute product development activities throughout the product lifecycle, including concept development, prototyping, verification, validation, commercialization, and design changes. - Apply Design Control and Risk Management principles in compliance with FDA regulations, ISO 13485, ISO 14971, and company procedures. - Develop and maintain Design History File (DHF) documentation, technical records, test plans, protocols, reports, and related product development documentation. - Design and conduct engineering, verification, and validation testing; analyze results and recommend product improvements. - Utilize CAD, modeling, and prototyping tools to develop and evaluate product designs. - Investigate and resolve technical issues using sound engineering principles and structured problem-solving methodologies. - Support intellectual property activities through invention disclosures, patent documentation, and evaluation of potential patent and competitive landscape considerations. - Participate in design reviews, risk assessments, and cross-functional project teams to ensure product quality, compliance, manufacturability, and performance requirements are achieved. - Collaborate with Quality, Regulatory, Operations, Manufacturing, Supply Chain, Marketing, and other stakeholders to support product development and commercialization efforts. - Manage project tasks, timelines, risks, and deliverables, and communicate project status and technical findings to stakeholders and leadership. - Perform other duties as assigned. **Education and/or Experience** - Bachelor of Science in Industrial Design, Mechanical Engineering, Biomedical Engineering, Product Design, or related technical discipline. - 3+ years of product development, design engineering, or R&D experience. - Experience participating in product development projects from concept through commercialization. - Knowledge of engineering design principles, materials, manufacturing processes, and product testing. - Proficiency with CAD software (SolidWorks preferred). - Strong analytical, problem-solving, and technical documentation skills. - Effective communication and collaboration skills in a cross-functional environment. **Preferred Qualifications** - Experience in the medical device, healthcare, consumer products, or other regulated industry. - Experience with FDA Design Controls, ISO 13485, and Design History Files (DHF). - Knowledge of ISO 14971 risk management principles. - Experience developing and executing verification and validation…