Principal Product Development Engineer

Responsibilities

• Anticipates business challenges and/or regulatory issues, reviews and recommends products/services and process improvements to the board of the business group
• Looks beyond existing methodologies and the own discipline to define and resolve highly complex problems
• Internal and external thought leader influencing change and advancement of the industry and/or profession
• Recognized technical principal and internal thought leader in own area of responsibility w/in the business group
• Significantly contributes to the development of the functional strategy (e.g. R&D, Manufacturing, Sales) of the business group
• Requires broad and comprehensive expertise in theories, techniques and/or technologies within own field which have a broad impact on the business
• Anticipates business and regulatory issues; recommends product process or service improvements
• Oversees introduction of value-adding, technical solutions and leads/directs introduction of emerging technologies
• Requires conceptual and innovative thinking to develop solutions
• Impacts the direction and resource allocation for program, project or services; works within general functional policies and industry guidelines
• Communicates highly complex ideas, anticipates potential objections and persuades others at senior management levels to adopt a different point of view
• Lead others to solve unique and highly complex problems which have a significant impact on innovation and a broad impact on the business

Qualifications

• 12 years of Medical Device design & development experience
• Bachelor of Science in Mechanical, Biomedical Engineering, or related discipline. Master’s degree preferred
• 21CFR Part 820.30 Design Controls, ISO 13485, ISO 14971 ISO 10993 and IEC 62366
• Knowledge of silicone and plastic molding preferred
• Hands-on experience with machining and 3D prototyping methods preferred
• Good communication & interpersonal skills
• Excellent mechanical, analytical & problem-solving skills