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 Principal Systems Engineer to join our Product Development team.
This role is responsible for leading or assisting in the design and implementation of system and software solutions for new products, major product enhancements, and critical subsystems. Certain aspects of this role will require strong modeling and algorithm development skills. Assignments are broad in nature, usually requiring appreciable initiative, originality, and ingenuity. This candidate will serve as a technical lead for a variety of design activities and will regularly give technical guidance to other Product Development engineers and management.
Essential Duties and Responsibilities:
As part of product development team, perform one or more of the following duties as assigned by Product Development Manager to support the team’s goals:
- Provide expertise on engineering systems; plan, advise, analyze, design, test, and manage highly complex engineering software systems.
- Develop, maintain, and apply a variety of system (patient/sensor/hardware) models through the use of clinically derived data.
- Responsible for design and development of systems that, while focusing on software, will span the engineering disciplines of mechanical, electromechanical, electrical, and application software.
- Provide broad technical leadership in area of expertise helping company set technical direction and course for future programs.
- Research and recommend design options and perform experiments to determine potential design feasibility or application.
- Serve as technical leader for major development projects including development of devices in new technology or multiple simultaneous sub-projects. Responsible for ensuring that design activities are coordinated per the development procedure. Establish and maintain project schedules.
- Strong mentor to other engineers and technicians.
- Exercises wide latitude in determining objectives and approaches to critical assignments.
- Possess a highly polished degree of personal communication skills, both written and verbal.
- Communicates both within and external to the company.
- Responsible for design/development activities which may include leading, participating, or supporting Concept, planning, design and execution stages, including:
- Risk assessment
- Concept validation
- Verification testing
- Desk reviews
- Product validation
- Participate in the all phases of development across multiple projects; investigate interchangeability, replacement, cost factors, and ease of manufacture. Coordinate with project team to create and release Product Requirements, Design Specifications and Design Descriptions for assigned designs applicable standards and procedures. Work with all Project team members throughout the development in order to ensure that products are produced in a safe, efficacious and quality manner while keeping within established time frames.
- Prepare technical reports including Design of Experiments (DOE), external interfaces, internal interfaces, component qualification, product testing, FMEA, statistical analysis.
- Assess and recommend design and development activities to determine time for completion and appropriate staffing and/or use of outside resources to reach goals.
- Evaluate potential product improvements and recommend design modifications.
- Education & Experience:
- Bachelor’s Degree in Engineering, Biotechnology, Computer Science, Engineering Technology or equivalent technical Degree; or equivalent combination of education and experience.
- 15+ years related engineering experience
- Demonstrated technical experience in developing complex software and/or hardware systems from an end user perspective.
- Experience in system modeling, system simulation, and/or design of experiments.
- Strong computer based analytical skills (using tools such as Matlab, Mathcad, R, NumPy)
- Software: Experience with assembly-level and C code development, real time signal processing, and I/O control.
- Self-starter; highly-organized; detail-oriented; highly-motivated; team player; analytical; strong interpersonal & verbal/written communication;
- Customer-Focused; Results-Driven; Initiative; “Can-Do” Attitude.
- Advanced Degree (Masters or PhD) in Engineering, Biotechnology, Computer Science, Engineering Technology
- Strong background in development of system solutions for medical devices.
- Background in sensing, especially near infrared optics.
- Strong background in development of microprocessor controlled hardware.
- Software development experience in an embedded environment for medical devices.
- Experience with Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment.
- Proven technical expertise in technical area directly applicable to development of Nonin’s new devices.
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