Massachusetts Green Jobs

• Accomplished Senior Staff Engineer with over 10 years of specialized expertise in Verification and Validation within the Medical Device Industry.

• Demonstrated proficiency in adhering to IEC 60601 product safety standards and implementing rigorous statistical analysis and engineering strategies

• Proven track record includes successfully leading projects through the design validation and verification phases for Class 2 and Class 3 medical devices.

• Skilled in mentorship, project management, and ensuring full project lifecycle completion from planning to dissemination of results. Adept at integrating technical responsibilities with a deep understanding of regulatory requirements to achieve organizational goals effectively.

Major Duties and Responsibilities:

• Conducted rigorous testing and validation of medical device designs.

• Coordinated with cross-functional teams to ensure alignment with regulatory standards.

• Detail-oriented with strong analytical skills.

• Effective communicator and team player.

• Proven ability to thrive in fast-paced environments.• Developed and executed comprehensive test plans for product verification.

Requirements/Qualifications:

• IEC 60601: Product Safety Standards for Medical Devices

• 10+ years of experience.

• REQUIRED - 5 years working at a company in the Medical Device Industry. (He does not want to see any resumes less than 5 years. Please identify company that qualifies in your submission notes)

• Experience and understands statistical analysis and engineering strategies.

• Is able to understand how to complete the technical responsibilities, understands why they exist and the purpose and can master the planning and preparation stages of executing the goal.

• Is well versed enough to be a mentor and teach others.

• REQUIRED - Has experience with Class 2 and Class 3 Devices

• REQUIRED - Has completed at least one project of Design Validation vs Verification for Med Device Development and dissemination test validation cycle.

• If a candidate has a series of contract work in their work history, this worker will need to provide solid examples of how they fulfilled their project from start to finish.

• A huge plus would be experience with fusion pumps!

Education Required: Any degree

Technical Skills:

• Statistical Analysis

• Regulatory Compliance (IEC 60601)

• Design Validation and Verification

• Project Management

• Mentorship and Training

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To learn more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.