Senior Engineer, Product Development

• Device Design & Problem Solving: Research, design, develop, modify, and verify mechanical components for medical devices; translate design inputs into engineering specifications; and apply , both fundamental and advanced engineering principles to solve complex challenges.
• Clinical & Customer Insight: Demonstrate deep understanding of customer needs, product use, and clinical procedures to inform design decisions.
• Regulatory Compliance: Follow industry standards, design requirements, and test strategies to ensure compliance with regulatory requirements.
• Engineering Documentation & Design Controls: Independently create and refine engineering documentation-such as Design History Files-while adhering to R&D procedures including design controls and risk management in alignment with the Quality Management System.
• Cross-Functional Collaboration: Partner with R&D, Quality, Regulatory, Manufacturing, Marketing, Project Management, and Clinical teams to drive successful project execution.
• Independent Execution: Operate with minimal supervision, managing tasks, priorities, and deliverables across projects efficiently.
• Team Contribution & Adaptability: Work as a collaborative team member, quickly adapting to new systems and processes while fostering strong working relationships.

What You Need
Minimum Qualifications:
 

• Bachelor of Science in Engineering, Mechanical Engineering or Biomedical Engineering, or a related discipline
• 2+ years of work experience

Preferred Qualifications
 

• Experience with a parametric CAD design package. Creo preferred.
• Experience in FDA-regulated or highly regulated industry preferred.
• Working knowledge and understanding of mechanical engineering practices and design principles
• Technical ability to create engineering drawings and models, applying GD&T and CAE tools.
• Demonstrated ability to apply knowledge of materials and manufacturing processes to product design.
• Ability to communicate basic plans and technical information to team members