Product Development Engineer

1 PURPOSE The Product Development Engineer is an active contributor to Bridge to Life’s (BTL) new product development initiatives across the full product development lifecycle—from early concept and specification development through verification, validation, design transfer, as well as product improvements. This role is expected to contribute meaningfully to V&V testing, design controls, risk management, and technical documentation. 2 DUTIES AND RESPONSIBILITIES Verification & Validation Plans, executes, and documents V&V testing in accordance with approved protocols, test methods, and work instructions. Authors and reviews test protocols and reports, ensuring traceability to design inputs and outputs. Assembles prototypes, prepares test samples, evaluates components, and performs bench testing in support of new product development. Performs basic troubleshooting of test equipment and product prototypes; escalates complex issues as appropriate. Maintains laboratory organization, equipment readiness, and calibration records. Collaborates with external test houses to coordinate and support testing activities. Supports installation qualification (IQ) and operational qualification (OQ) of analytical and test equipment. Design & Documentation Contributes to the preparation and maintenance of design history file (DHF) documentation, including design inputs, design outputs, and traceability records. Assists in writing and reviewing product and material specifications, engineering drawings, and related technical documents. Assists in writing and reviewing engineering change orders. Participates in the development and review of risk management documentation, including FMEAs, in accordance with ISO 14971. Completes formal design reviews (PDR, CDR, design input / output reviews). Supports NCR and CAPA processes. Supports compliance with applicable industry standards and regulations (FDA QSR, ISO 13485, and others) throughout the product development lifecycle. Product Development Lifecycle Actively contributes to new product development projects across the full development lifecycle, from concept and feasibility through design transfer and launch. Conducts feasibility studies to assess viability and potential impact of new design concepts. Collaborates cross-functionally with Engineering, Quality, Manufacturing, Regulatory, and external partners to ensure development tasks are executed accurately and on schedule. Contributes to design control activities, risk management processes, and technical documentation across all active development projects. 3 QUALIFICATIONS Education & Experience Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related technical field required. 2+ years of experience in product development, V&V testing, or a related engineering role in the medical device or similarly regulated industry required. Hands-on experience executing V&V testing and authoring technical documentation (protocols, reports, specifications) required. Technical Skills Understanding of design controls, including design inputs, design outputs, verification, validation, and design traceability as applied to medical device development. Familiarity with risk management principles and tools (FMEA, ISO 14971) required. Knowledge of Good Laboratory Practices (GLP) and Good Documentation Practices (GDP). Familiarity with quality management systems including FDA QSR and ISO 13485. Understanding of accuracy, precision, repeatability, and proper use of significant figures in test data. Knowledge of basic electronic troubleshooting, including voltage checks, soldering, and sensor functionality checks. Proficiency with Microsoft Office; ability to use and navigate software associated with laboratory and test equipment as required. Professional Skills Strong written and verbal communication skills, with the ability to author clear, concise technical documentation. Strong analytical and problem-solving skills with excellent attention to detail. Effective time management and the ability to manage multiple tasks across concurrent development projects. Collaborative mindset with the ability to work effectively across cross-functional teams. 4 WORKING CONDITIONS This position is hybrid and reports into our Duluth, Georgia office. Workstation area: office, facility, and/or cubicle. The position requires a combination of desk work and active laboratory time. Ability to lift and carry objects weighing up to 15 lbs. Ability to travel up to 10% of the time, as needed. #J-18808-Ljbffr