Project Engineer, Medical Safety

Project Engineer, Medical Safety

Intertek, a leading provider of quality and safety solutions to many of the top recognized brands and companies, is actively seeking a Project Engineer, Medical Safety to join our team in Fridley, MN
.

What are we looking for? This position is responsible for developing and setting up biomedical test plans for a variety of customer products in collaboration with team members. The role requires 20% domestic travel and 5% international travel.

Salary & Benefits Information – Salary range: $113,277 - $114,277/year. Individual compensation packages are based on a variety of factors unique to each candidate including skill set, experience, qualifications, and other job‑related reasons. In addition to competitive compensation packages, benefits include medical, dental, vision, life, disability, 401(k) with company match, generous vacation/sick time (PTO), tuition reimbursement and more.

What you’ll do: (Listed examples are illustrative and representative of the tasks required of this position and are not intended to be complete or exclusive.)

• Develop and set up biomedical test plans for a variety of customer products in collaboration with team members.
• Review test specifications and biomedical instructions to determine conditions under which tests are to be conducted.
• Analyze and interpret test data.
• Read and determine applicability of national codes and standards clauses for the equipment under test.
• Review sequences and phases of test operations and prepare technical reports based on findings.
• Perform evaluations on a variety of biomedical and medical safety products to the provisions of U.S., Canadian and other international product safety standards.
• Collaborate with quality assurance staff to prepare product specification and safety sheets, standard operating procedures, user manuals, qualification and validation reports.
• Report test results to management and recommend changes to medical safety testing in an effort to improve company efficiency and the quality of manufacturing.
• Build and configure medical testing systems and equipment.
• Build and calibrate test fixtures.
• Conduct thorough construction review and report results to management.

Minimum

Requirements & Qualifications:

• Bachelor’s degree in Engineering, Materials Science and Engineering or related field of study.
• 3 years of experience as a Process Integration Engineer, Quality Assurance Engineer, Undergraduate Research Assistant or related role.
• Independently conduct on‑ and off‑site evaluations of products to determine compliance with applicable standards.
• Determine applicability of national codes and standards clauses for the equipment under test.
• Laboratory testing skills such as using test equipment, following protocols, developing test plans and documenting results.
• Manage projects for key medical clients resulting in Net Promoter Scores of 70+ and repeat business from said clients.
• Meet individual KPIs including but not limited to Conforming Workflow, Promised Completion Dates (PCD), TAT (Turnaround Time) and Accrual target.
• Demonstrated experience with U.S., Canadian, and other international product safety standards including IEC 61010 and 60601.
• Define problems, collect data, establish facts and draw valid conclusions.
• Interpret an extensive variety of technical instructions in mathematical or diagram form.
• Analyze abstract and concrete variables.
• Make technical decisions and engineering judgments independently within established parameters.
• Work with medical clients on their regulatory needs.
• Applicants will be required to complete an I‑9 to verify their eligibility to work in the U.S.

Intertek Total Quality Assured

Intertek is a world leader in the Quality Assurance market, with a proven, high‑quality business model and a global network of customer‑focused operations and highly engaged subject‑matter experts. With passion, pace, and precision we work to exceed our customers’ expectations, while engaging with our employees to be 10X in their performance and professional growth.

Intertek is a drug‑free workplace. For certain safety‑sensitive roles, a pre‑employment drug screen will be required. Based on local law and…