Product Development Engineer

Position Summary 

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Vesco Medical is seeking an experienced Product Development Engineer to independently lead technical workstreams and assigned medical-device development projects from concept through commercialization and post-market support. This position will develop products, manage design-control deliverables, execute verification and validation, and collaborate with internal teams and external manufacturing partners. Direct medical-device development experience, working knowledge of FDA requirements, and demonstrated experience in an ISO 13485-compliant quality management system are required. 

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Primary Responsibilities 

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• Lead assigned medical-device projects and technical workstreams from concept through design transfer, commercialization, and sustaining support. 
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• Translate customer, clinical, business, and regulatory needs into clear user needs, design inputs, engineering specifications, and acceptance criteria. 
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• Develop product concepts, drawings, prototypes, test methods, tolerance analyses, and manufacturing requirements. 
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• Own design-control deliverables, including development plans, design reviews, traceability, design outputs, verification and validation documentation, and Design History File records. 
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• Plan and execute bench testing, characterization studies, reliability testing, verification, and validation; analyze results and author technical reports. 
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• Apply ISO 14971 risk-management principles, including hazard analysis, design FMEAs, risk-control definition, and risk-control verification. 
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• Develop project plans, schedules, budgets, and risk registers; communicate status and escalate material risks or schedule concerns promptly. 
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• Work with suppliers and contract manufacturers to specify components, tooling, processes, inspection methods, and production controls. 
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• Apply design-for-manufacturing and design-for-assembly principles to improve product safety, quality, reliability, scalability, and cost. 
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• Support design transfer, pilot builds, process validation, and production implementation in collaboration with Operations and Quality. 
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• Lead or support root-cause investigations, nonconformances, complaints, CAPAs, supplier changes, and product improvements. 
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• Prepare technical documentation supporting FDA submissions, including 510(k) submissions and responses, as applicable. 
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• Ensure development work complies with Vesco procedures, FDA requirements, the Quality Management System Regulation, ISO 13485, and other applicable standards. 
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• Provide clear technical communication to management, project teams, customers, suppliers, and other stakeholders. 
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Required Qualifications 

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• Bachelor's degree in mechanical, biomedical, electrical, plastics, manufacturing, or another relevant engineering discipline. 
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• At least three years of product-development engineering experience in the medical-device industry. 
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• Demonstrated experience working within an ISO 13485-compliant quality management system. 
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• Working knowledge of FDA medical-device requirements and design controls under 21 CFR Part 820 / the Quality Management System Regulation. 
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• Experience creating and maintaining design-control and Design History File documentation. 
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• Hands-on experience with medical-device verification and validation, test-method development, protocol execution, data analysis, and technical report writing. 
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• Experience applying ISO 14971 risk-management methods such as hazard analysis and FMEA. 
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• Demonstrated ability to independently solve technical problems and manage multiple project priorities. 
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• Strong written, verbal, and cross-functional communication skills. 
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Preferred Qualifications 

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• Experience establishing and operating a fluid-characterization laboratory, including equipment and fixture selection, calibration controls, data capture, and repeatable testing of fluid-delivery systems using representative fluids under simulated-use conditions. 
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• Experience with injection-molded plastics, flexible tubing, bonded joints, and electromechanical assemblies. 
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• Experience supporting FDA 510(k) submissions and product changes. 
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• Familiarity with IEC 62366-1, ISO 10993, ISO 80369-3, IEC 60601, or IEC 62304, as applicable. 
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• Experience with competitive product teardowns and performance, feature, and usability benchmarking; ability to translate findings into design inputs and development priorities. 
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• Experience working with domestic and international suppliers or contract manufacturers. 
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Core Competencies 

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Independent technical judgment; structured problem-solving; project ownership; design-control discipline; risk-based thinking; collaboration; clear communication; commitment to patient safety and product quality. 

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Physical and Travel Requirements 

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• Ability to work in office, engineering laboratory, and manufacturing environments and to handle prototypes, test equipment, and production components. 
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• Ability to travel periodically to suppliers, contract manufacturers, test laboratories, customer sites, and other Vesco locations, including occasional international travel. 
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About Vesco Medical 

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Vesco Medical develops and supplies enteral feeding products designed to support safe, effective, and reliable nutritional delivery. Our teams collaborate across engineering, quality, regulatory, manufacturing, supply chain, and commercial functions to deliver practical solutions that improve patient care and customer experience. 

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Vesco Medical is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, or any other status protected by applicable law. 

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