Product Approval Engineer

Thermo Fisher Scientific Inc. is the world leader in serving science. With annual revenue exceeding $32 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create meaningful contributions to the world. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

This key role will be based in Asheville, NC, a vibrant and artistic city with world class outdoor experiences and eclectic culinary scene. You will work with our Laboratory Products Division in the Controlled Temperature Technologies (CTT) Business Unit. You will be immersed in a collaborative culture with resources to deliver the refrigerated lab equipment that our customers need to achieve their scientific goals - quickly, reliably and safely. Some support of other locations may be required occasionally.

How will you make an impact?

As the Product Approval Engineer, you will collaborate with R&D engineering teams that execute project initiatives & strategies across the Business Unit. This position will help drive a culture of detailed and well-reasoned evaluations of new products with insight to customer needs, engineering specifications, and regulatory requirements. A broad multi-disciplinary mechanical, electrical & refrigeration experience coupled with a knowledge of the relevant regulatory landscape will be instrumental to drive successful verification and validation plans for medical devices.

What will you do?

• Coordinate a product approval process for design, development, and qualification of products within a medical device development framework.
• Ensure compliance to regulatory standards by coordinating between design teams and the Regulatory Affairs team. Verify all required compliance activities are identified and executed.
• Develop and document V&V plans collectively with R&D teams. Assist in the testing and compilation of the data package vital to supporting those plans in a timely fashion.
• Coordinate the creation of verifiable product requirements that will improve product success and delight customers.
• Support the successful completion of audit activities by internal or external authorities by having documentation properly organized and accurately completed to relevant procedures.
• Ensure a robust product approval process by collaborating with multiple functions such as Reliability, Software, Quality, and Manufacturing.

How will you get here?

Education/ Experience

• Bachelor's degree in Mechanical or Electrical Engineering with 8 years related industry experience.
• An advance degree with 6 years of related experience. Master's Degree highly preferred.
• Educational equivalence may be considered with additional years of related industry experience.
• 3+ years of proven experience in the development and approval of electromechanical systems.
• Specialization in Systems Engineering preferred.
• Refrigeration and Medical Device experience required.

Knowledge, Skills, Abilities:

• An in-depth understanding of multiple engineering fields including mechanical, electrical, electronics, and thermal.
• Knowledge of regulatory and safety requirements for electrical equipment for measurement, control, and laboratory use as well as medical device requirements through standards similar to UL61010, ISO13485, & ISO14971.
• Proven history of influencing the design and development of commercial products.
• A track record of implementing process changes in an organization.
• Ability to manage multiple tasks and priorities.
• Excellent verbal and written communication skills with experience communicating in a global environment and across differing levels of technical understanding.
• Ability to maintain strict confidentiality.
• Ability to travel up to 10%

Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.