We are hiring an Engineering Manager, Product Development!!! This role will support our client's radiation protection wearables in a new division of our their company. This position can be fully remote within the US.
Ideally living in the within 2 hours of our PA and VA sites and/or must be willing to travel to any of our current or future locations. Estimated travel for the at least the first year will be 20 - 30% SUMMARY The Engineering Manager, Product Development is responsible for leading an engineering/technical team. The position is remote and reports to the VP, Product Development Engineering.
The Engineering Manager will manage associates in company locations as well as remote employees. Working closely with Marketing Product Managers and other cross-functional leaders, the individual will drive delivery of new products, line extensions, and product improvements for the business segments according to business strategy. The individual will also participate in strategic planning and budgeting.
ESSENTIAL RESPONSIBILITIES Manages team of 2-3 development engineers and technical specialists Drives execution of product development projects across one or more Product Lines. Considered a subject matter expert on FDA and ISO Design Controls, Risk Management and Design Transfer. Supports other Quality Management Systems (QMS) functions.
Teaches and assists on technical, compliance, standards and development of specifications. Coordinates, analyzes and supervises testing to support marketing claims. Reviews and approves projects, protocols, drawings and documentation for accuracy and to ensure they meet applicable internal and external standards.
Qualifies and engages outside design firms, testing labs and technical consultants. Assists in the development of PD strategy and tactics. Assists directly with discovering and articulating unmet customer needs.
As necessary, acts as project manager for highly complex and impactful PD projects Proactively identifies and brings forward to the commercial team new technologies, product concepts and designs for consideration EDUCATION AND EXPERIENCE BS Degree in Engineering (Mechanical, Chemical Engineering or Material Science preferred). 8 years experience as an engineer in a medical device company 3 years experience supervising, managing, and/or leading project teams. Some direct management experience of engineers and/or technical specialists preferred.
Significant experience in medical device development under FDA 21 CFR 820.30 Design Controls, ISO13485 and ISO 14971 Risk Management. Both reusable and disposable product development experience strongly preferred. Some Working knowledge of U.S.
and international standards as applicable to medical device development Experience developing medical devices produced in Asia and/or Mexico preferred. Strong engineering, analytical and technical skills Demonstrated ability to mentor and develop engineers Demonstrated effective communication skills Successful team player; demonstrated successful interpersonal and influence management skills Track record of successfully collaborating with multiple functions and teams to drive successful project outcomes Demonstrated project management skills. Ability to travel up to 10-15% of the time, with occasional travel to Mexico and/or Asia.
Energetic, self-motivated and can work independently; demonstrated strong work ethic. #J-18808-Ljbffr