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 dynamic Senior Biomedical Engineer to join our Advanced Development team.
The senior engineer will be responsible for conceptualizing and prototyping new, noninvasive physiological monitoring devices. Assignments are broad in nature, requiring appreciable initiative, originality, and ingenuity. Coordinates design activities, reviews and reports design progress, and evaluates results. Guides technical course of the company in biomedical engineering expertise.
Essential Duties and Responsibilities:
As part of the Advanced Development team, perform one or more of the following duties as assigned by the Product Development Manager to support the team's goals:
- Provide physiological expertise in medical and biological sciences to facilitate advances in non-invasive monitoring devices. This expertise will be leveraged for device design, clinical study design, clinical study data analysis, design of experiments, and usability.
- Provide software and algorithm development expertise for engineering systems; plan, advise, analyze, design, test, and manage highly complex engineering systems.
- Interact with end users to develop a robust understanding of unmet needs for current and future device designs.
- 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 advanced development projects including development of devices in new technology or multiple simultaneous sub-projects. Responsible for ensuring that design activities are coordinated per the requirements. Establish and maintain project schedules.
- 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.
- Responsible for design and development of systems that span the engineering disciplines of biomedical, algorithm development, electrical, embedded software, and PC software.
- Strong mentor to other engineers and technicians.
- Responsible for design/development activities which may include leading, participating, or supporting:
- Concept, planning, and feasibility stages
- Risk assessment
- Concept validation
- Verification testing
- Design reviews
- Participate in the all phases of development across multiple projects; investigate interchangeability, replacement, cost factors, and ease of manufacture. Coordinate with project team to define Product Requirements through interactions with end users.
- Evaluate potential product improvements and recommend design modifications.
- Education & Experience:
- Bachelor’s Degree in Biomedical Engineering, Biotechnology, or equivalent technical Degree; or equivalent combination of education and experience.
- 7+ years related engineering experience
- Required Knowledge, Skills & Abilities:
- Strong physiological background, preferably in the areas of perfusion and ventilation
- Demonstrated technical experience in applying bioscience theory to engineering
- Strong root cause analytical skills
- Experience in system modeling, system simulation, and design of experiments
- 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 or equivalent technical Degree; or equivalent combination of education and experience.
- Proven technical expertise in technical area directly applicable to development of Nonin’s new devices.
- Strong background in development of system solutions for medical devices.
- Background in sensing, especially infrared optics.
- Background in development PC applications.
- 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.
- Demonstrated experience in successful project management.
- Ability to sit, stand, and/or walk for 8 hrs/day.
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