Senior Quality Engineer (Product Development)

Nonin Medical, Inc.

Small company environment, global opportunities, infinite rewards.

Come be a part of something bigger.

 

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 an experienced Senior Quality Engineer to join our expanding Quality team!

 

The Senior Quality Engineer is responsible for ensuring that all new and existing products meet company specifications as well as national and international standards requirements for safety and performance.  The individual in this role establishes and implements standard test procedures which demonstrate acceptable product performance.  This position reports to the Quality Manager-Product Development.

 

The ideal candidate will possess a BS degree in electrical engineering and 5+ years of related experience with a product development quality focus in medical device or other high tech industry. 

 

Responsibilities:

· Provide management and direction to the product development team ensuring appropriate resource allocation, and project completion in accordance with company goals and objectives.

· Participate in department strategic planning activities and lead in the execution of department and company goals and objectives.

· Establish and implement validated test and inspection methods for use throughout the organization.

· Serve as the QA representative on product development teams providing clear and concise quality goals including national and international standards and requirements.

· Develop and communicate effective quality plans for new product development and continuation engineering activities.

· Participate in the development of world class quality standards and guidelines.

· Demonstrate a level of leadership capability recognized throughout the organization.

· Assist Regulatory Affairs in the preparation of regulatory submissions and interface with the FDA or other regulatory agencies during on-site audits.

· Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.

· Provide investigative support for product complaints and/or safety issues.

· Develop and conduct training programs pertaining to quality systems, quality practices and technical standards developments.

 

Minimum Qualifications:

· Education & Experience: Bachelor’s degree in electrical engineering or other relevant discipline along with 5+ years of QA experience in medical device or other high tech environment.

· Demonstrated ability to read schematics.

· Thorough knowledge of national and international product safety and performance standards.

· Strong leadership, communication and analytical skills.

· Strong proficiency in Microsoft Office suite (Word, Excel, Project & Outlook).

 

Preferred Qualifications:

· Knowledge of EMC and electrical safety testing.

· Knowledge of FDA QSR requirements.

· Knowledge of ISO 13485 and other recognized international quality system standards.

· Knowledge of world class quality techniques and implementation.

 

Nonin offers an excellent total compensation package including competitive salaries and comprehensive benefits with medical, dental, profit sharing and 401(k) contribution. 

 

Qualified candidates should submit resume, cover letter, and salary requirements to:

Nonin Medical, Inc.

Attn:  Human Resources

13700 1st Avenue North

Plymouth, MN  55441

jobs@nonin.com (e-mail preferred)

NO PHONE OR AGENCY CALLS PLEASE