Nonin Medical, Inc. is a rapidly growing international medical device manufacturer that has been designing and distributing high quality medical monitoring devices since 1986. Headquartered in Plymouth, MN, we offer a rewarding work environment with global opportunities while maintaining a small company, employee-focused atmosphere. We are currently searching for a Lead Project Engineer to join our Product Development team
The Lead Project Engineer manages Product Development department projects with significant scope. These projects are typically multi-disciplinary and complex in nature. The Lead Project Engineer defines all design resource needs within the department and company to ensure the successful and timely release of new products. As part of the product design process, the Lead Project Engineer also determines the need and recommends the services of outside design firms (e.g., industrial design, prototyping services, specialized test services, etc.). The Lead Project Engineer is also one of the main contacts between the Product Development group and its customers, both internal and external.
The Lead Project Engineer will interface with all functional groups within Nonin but there is an emphasis on the ability to work with the Sourcing and Manufacturing groups to ensure an efficient development process and smooth transition into manufacturing.
This position will report to the Director of New Product Development.
Essential Duties and Responsibilities:
- Work collaboratively with Product Marketing or Business Development personnel to define the scope of potential development projects and initial product requirements.
- Create, maintain, and communicate product development schedules with sufficient detail to ensure that all assigned personnel and groups external to the department are aware of their tasks and due dates.
- Develop and maintain a project development budget that includes parts, tooling and external professional services for assigned projects.
- Identify internal and external resources required to support the product development schedule; work with department management to ensure that these resources are assigned to the project.
- Ensure that required product documentation (requirements and design/product specifications) is created and released in a timely manner to allow efficient design progress.
- Maintain the design history file (DHF) for the project throughout the development process.
- Adhere to Nonin’s Product Development Process (PDP).
- Represent the Product Development department on cross-functional teams.
- Participate in required management reviews for assigned projects and present the Product Development status in these reviews.
- Coordinate and communicate project status with appropriate levels of management throughout the company.
- Required Education & Experience:
- Bachelor’s degree in Engineering, Biotechnology, Engineering Technology, or equivalent technical degree; or equivalent combination of education and experience.
- 10+ years of engineering or product development experience.
- 4+ years of project lead experience
- Demonstrated experience in successful project management.
- Demonstrates excellent organizational and team leadership skills.
- Experience in building and leading cross-disciplinary project teams.
- Demonstrates strong negotiating skills.
- Excellent written and oral communication skills.
- Strong computer skills (MS Word, Excel, PowerPoint, Outlook, Internet).
- Significant experience using project management software tools (MS Project or equivalent).
- Experience utilizing enterprise resource planning (ERP) tools.
- Familiarity with the essential requirements of the Medical Device Directive (MDD).
- Advanced degree in Engineering (eg., MSEE), Engineering Management, or Business (eg., MBA).
- Experience leading medical device (Class II or Class III) development projects.
- Experience with Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment.
- PMP or NPDP certification.
Qualified candidates can mail, e-mail, or fax resume and salary requirements to:
Nonin Medical, Inc.
Attention: HR Department
13700 1st Avenue North
Plymouth, Minnesota 55441-5443