Principal Product Development Engineer

Responsibilitiesarrow_right

* 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.

Qualificationsarrow_right

* 12 years of Medical Device design & development experience.

* Bachelor of Science in Mechanical, Biomedical Engineering, or related discipline. Master's degree preferred.

* 21

CFR Part 820.30 Design Controls, ISO 13485, ISO 14971 ISO 10993 and IEC 62366.

* 3D solid modelling (e.g. Solid Works or related software).

* Hands-on experience with machining and 3D prototyping methods preferred.

* Knowledge of silicone and plastic molding preferred.

* Good communication & interpersonal skills.

* Excellent mechanical, analytical & problem-solving skills.