Sr Software Quality Engineer Job

Sr Software Quality Engineer

Requisition 80768
Category Regulatory Affairs and QA
Business Surgical Technologies
Division RTG ST-Surgical Navigation
Location USA-MA-Littleton
Relocation No relocation assistance
Job Type Full Time - Regular
Exempt/Non-Exempt Exempt
Shift First
Travel Percentage 10 - 20%
Experience Required 5 years
Education Required Bachelors Degree

Medtronic is an Equal Opportunity/Affirmative Action Employer


Position Description

Works with minimal guidance to support the design, development, test, and market release of software used in both surgical navigation applications and other medical devices. Contribute to the processes and tools used to create and test software applications. Develop and assess the quality programs and systems of Medtronic Navigation to applicable standards.

Position Responsibilities

- Provide guidance on Quality System Practices as defined by Medtronic Navigation Littleton’s practices, policies and Standard Operating Procedures to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.
- Actively participate in product development cycle to ensure Quality issues are addressed and resolved prior to release. Work closely with R&D to develop appropriate qualifications, validations, inspection plans and gauging including reliability assessment for both new design and changes to released product. Assure the resolution of all issues raised by the testing.
- Assess, provide recommendations, and lead implementation of systems, processes and equipment for improvement and compliance to Good Manufacturing Practices within the R&D, Operations and QA/RA processes to ensure safe and effective products are produced. Provide written reports and supporting documentation for recommendations.
- Lead problem solving efforts to identify and resolve recurring and new quality issues to ensure production of safe and effective medical devices.
- Perform DHF audits and conduct independent review of product verifications and validations.
- Lead software complaint investigations and trending; document findings and provide reports and analysis. Recommend and implement corrective action and appropriate follow-up when necessary. Ensure documentation and findings are completed in a timely manner and in compliance with FDA and European Regulatory agency standards and procedures; recommend and implement actions or changes to improve quality.
- Conduct risk management activities and recommend an appropriate course of action via CAPA systems.
- Devise, implement, and conduct methods and procedures to validate software tools utilized in the production environment.

Basic Qualifications

EDUCATION REQUIRED
- BS/MS in Engineering or a related field

YEARS OF EXPERIENCE
- 5+ years engineering experience with BS

SPECIALIZED KNOWLEDGE REQUIRED
- Excellent oral and written communication skills.
- Ability to work in a team environment.
- Previous experience in a quality position in a regulated environment
- Strong working knowledge of electromechanical assemblies, special processes, process validation techniques, software life cycle management, software test methodology, FMEA and design control.

Desired/Preferred Qualifications

- Experience in the medical device industry with emphasis on capital equipment a plus.
- Preference given to local talent

Physical Job Requirements

PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, sit, walk, talk, hear and reach with hands and arms. The employee frequently is required to use hands to finger, handle, or feel objects, tools, or controls. Specific vision abilities required by this job include normal vision.

WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet to moderate.

Nearest Major Market: Boston
Job Segments: CAPA, Compliance, Developer, Engineer, Engineering, Finance, Healthcare, Inspector, Law, Legal, Management, Manufacturing Engineer, Medical Device, Medical Device Engineer, Medical Technology, Product Development, QA, Quality, Quality Assurance, Quality Engineer, R&D, R&D Engineer, Regulatory Affairs, Research, Risk Management, Senior Quality Engineer, Software Engineer, Technology, Testing