The Principal Engineer is Responsible for leading and managing high impact R&D initiatives including new opportunity identification, technology development, product development and line extensions in support of business objectives. They will interact with other departments such as management, research, engineering, marketing and new business development to identify core technical competencies that fit with current business focus and potential new markets. Apply sound technical and business principles to investigate new product development opportunities. Support Sales and Marketing in defining market and customer needs and in developing a business plan in target markets. Specify design requirements for current and future products by working closely with sales, marketing and healthcare providers, as well as, provide technical and project leadership over complex design, development and research projects and effectively provide guidance to project teams in development of products and technologies from concept to commercialization while adhering to medical device design controls/regulatory requirements. Define product specifications, design inputs, product design, verification testing and supporting design validation studies. Perform engineering analyses to support new and existing designs. Fabricate prototypes with assistance from junior staff, technical support team and internal and external suppliers, work with internal and external manufacturing partners to ensure producible designs (DFM), Contribute to company Intellectual Property Portfolio, Hold self and team members accountable to meet commitments and ensure budgets and schedules are well planned and followed. Effectively communicate activity status, issues and mitigation plans with key stakeholders
Minimum of B.S. Engineering discipline
Minimum of 10 years of experience in product development in the surgical, disposable products or related industries.
Experience interfacing and building relationships with Clinicians and KOL’s, familiar with Concept Engineering (i.e., VOC, observational research, ODI, etc.).
Proven track records of developing products from concept to launch,
Knowledge of cGMP’s and FDA/CE Mark regulatory requirements
Experience with Design for Six Sigma (DFSS) tools and methodology.
In addition: Sitting and standing for long periods of time ; bending ; squatting; lifting up to 30 lbs; attending tradeshows; observing surgery in OR. Travel up to 20%.