Product Development Senior Engineer

Job DescriptionJob Description

The Senior Engineer applies aspects of subject matter expert knowledge and experience in the identified discipline of engineering. This senior-level position is responsible for proactively recommending solutions and projects to management within departmental objectives. Capable of leading project teams and supervising other engineers and technicians. Provides input to budget and resource allocation without direct hire/fire responsibility. Measured against performance plan goals and objectives. Responsible for functional performance when applicable.

Duties and Responsibilities:

· Develop and execute project plans from concept through manufacturing including regulatory submissions (510(k)).

· Develop all product documents as needed (Product Requirements through manufacturing documents) to facilitate the release of the product to market.

· Provide leadership to the team, setting high expectations for behaviors consistent with IMI business goals, objectives, and standard of conduct.

· Provide technical leadership and mentorship to Product Development organization to ensure the best design solutions for products.

· Work cross-functionally and across other boundaries to opportunities for collaboration, integration, and coordination to maximize the efficiency and effectiveness of the organization.

· Ensure prompt and appropriate attention to ECNs, CAPAs, supplier quotations and product quality issues requiring engineering support.

· Develop Intellectual Property position through active patent filling, participation in competitive surveillance.

· Promptly and effectively deal with compliance and other performance issues in a manner consistent with company policies and practices.

· Other duties as assigned by the manager.

Qualifications:

· Bachelor’s degree in the engineering field, mechanical or equivalent.

· Advanced degree (MS Eng, MBA, etc.) .

· Minimum 5+ years of progressive engineering experience within the medical device industry, preferably with 3+ years in a project leadership role within product development, engineering, design, etc.

· Experience leading an R&D or Product Development team in FDA-regulated, ISO 13485-certified environments.

· Prior hands-on customer interaction and proven experience understanding true customer needs.

· Change management: willing to make hard fact-based decisions, comfortable with an uninstructed and changing environment.

· Passion for creating a framework for future products and technologies.

· Skilled at developing new ideas from both a product and process perspective.

· Strong understating of the principles of Lean Manufacturing and how to implement the tools in support of operational performance goals.

· Demonstrated practical application of Design FMEA, Value Engineering, and Design for Manufacturability concepts.

· Extensive experience in 3D CAD modeling and 2D dimensioning using Solidworks.

Physical / Mental demands:

· Working conditions are normal for an office environment.

· Work may require frequent weekend and evening work and a willingness to travel as required.