Sr Test Engineer - Exempt

Top 3 technical skills that are required for the role:
Verification & Validation Strategy Leadership Test Method Development & Validation Expertise Execution Discipline & Regulatory Documentation

Education Required/Years'Experience

Required:

Bachelor’s degree in engineering or scientific discipline and 6 years experience in technical testing or engineering experience OR Advanced Degree in engineering or scientific discipline and 4 years experience in technical testing or engineering experience

Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours a week Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Hybrid - 4 days in office, 1 day remote What is your timeline for scheduling interviews? Asap What product line will this person support?

Emprint product line

At *** , we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

As a Test Engineer within the Neuromodulation Interventional organization, you will utilize your expertise in test and engineering to deliver cutting edge products that focus on ablating tumors in patients.
*** has been shaping the approach to minimally invasive tumor treatment for over 25 years and is redefining standard of care for metastatic cancer in the liver with the revolutionary EmprintTM microwave ablation system with Thermosphere TM Technology.

The
*** Interventional team also invented the first balloon kyphoplasty devices for the treatment of vertebral compression fractures and continue to deliver breakthrough innovative RF ablation systems to treat metastatic and benign spinal tumors and alleviate chronic pain through targeted nerve ablation.

Within our R&D Department in
*** Neuromodulation, this employee will be part of a team that defines, develops and tests new products for the Neuromodulation business. The position responsibilities will primarily focus on system verification and validation (V&V) for Interventional products. This role is integral in the development cycle of any new product within this business.

They will be responsible for partnering with Systems Development engineering lead and design teams, Quality engineers and Program managers to drive meaningful design inputs, robust designs and ultimately an efficient and effective V&V strategy.

• Develop comprehensive plans for verification testing, including test method validation
• Create verification protocols with sample size justifications and acceptance criteria definitions
• Drive design input verification for sterilized disposable instruments, including but not limited to system compatibility, reliability, mechanical and tissue performance, partnering with design quality, systems, mechanical and electrical engineering partners and laboratory technicians
• Develop test methods, test method validation plans, and test method validation reports
• Clearly document a verification body of evidence through regulatory submission ready engineering reporting
• Support design validation of user needs with real end-users in real or simulated use environments
• Support design reviews and risk management activities
• Partner with manufacturing, quality, marketing, human factors, and regulatory teams to ensure the design is verified in compliance with medical device standards
• Execute minimally invasive therapy procedures and products in soft tissue per medical device standards and internal procedures
• Effectively communicate and present test findings, analysis and conclusions cross-functionally
• Provide senior-level technical leadership to internal engineers and external development partners

• Minimu…