Senior Product Engineer

Lead end-to-end product development activities including design, prototyping, testing, and validation

Drive technical decisions and provide engineering expertise throughout the product lifecycle

Develop and review engineering specifications, design documents, and technical reports

Identify and resolve complex engineering challenges using systematic problem-solving approaches

Partner with R&D, Quality, Manufacturing, Marketing, and Regulatory teams to ensure alignment

Serve as a technical resource and mentor for junior engineers

Communicate technical concepts clearly to both technical and non-technical stakeholders

Lead or contribute to multiple concurrent engineering projects

Define project scope, timelines, and deliverables

Track milestones and proactively manage risks and dependencies

Ensure products meet regulatory requirements (e.g., ISO, FDA, MDR) and internal quality standards

Support design verification and validation (V&V) activities

Participate in design reviews, FMEAs, risk assessments, and change control processes

Identify opportunities to improve products, processes, and engineering practices

Apply data-driven methods to analyze performance and drive decisions

Stay current with industry trends, emerging technologies, and best practices

Education B.S. in Mechanical, Electrical, Biomedical, or related Engineering field

Experience 5–8+ years of product engineering experience

Technical Skills Validation experience, design analysis, V&V testing

Domain Knowledge Understanding of product lifecycle management (PLM)

Communication Strong written and verbal communication skills

B.S. in Engineering or related field

Experience in medical device or regulated industry environments

Knowledge of ISO 13485, FDA 21 CFR Part 820, or similar regulatory frameworks