Test Engineering Manager

Cambridge, MA

We have an opportunity for a test engineering leader with a medical device background to join our client: an early stage company that is hitting its stride nicely, with an impressive investment team and partnerships with some of the most respected names in the industry.

• Oversee, coach, mentor and develop test engineering competence and state-of-the-art expertise. Specify engineering tools and upgrades
• Planning, deploying and managing the testing effort for any given engagement, conduct statistical analysis of test results
• Apply the appropriate test measurements and metrics for the product and the organization
• Resolve impediments to project progress, escalate when appropriate
• Communicate project test status to cross functional team and management
• Organize, monitor and control the testing process
• Ensuring traceability and controls of the testing process to deliver high-quality product
• Provide test strategy including applying automation where applicable
• Actively evaluate projects for opportunities to improve performance, cost reduction and schedule improvement whenever possible
• Continuously monitor risk and mitigate as appropriate
• Supervise test activities with third party (Test labs) for Standards and Reliability testing

• Bachelor of Science
• 8+ year’s medical device development experience (class II or III) along with a solid working knowledge of ISO 13485, IEC 60601-1-1 -2 -6 -8, IEC 62304, ISO 14971, FDA Quality System Regulations, and EU MDD/MDR
• Management experience preferred
• Ability to analyze requirements and develop a risk-based approach to testing
• Proficient computer skills with applicable software packages (e.g. Microsoft Office, Microsoft Project, Microsoft Power Point, etc.) and test data analysis software packages (such as Minitab)
• Good technical writing skills, including development of test methods, protocols, reports
• Familiarity with requirement management tools leading to generation of complete traceability matrices (i.e. Doors, Jama, Test Track, etc.)

Inquiries and resumes to: Kathy Provost at kathy@agilesearchinc.com OR 978/952-6425

For more information, please visit http://www.agilesearchinc.com/

Nov, 19, 2019