Project Engineer, Medical Safety

Intertek•Fridley, MN

About The Position

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 Project Engineer, Medical Safety position is responsible for developing and setting up biomedical test plans for a variety of customer products in collaboration with team members. This position requires 20% domestic travel, 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, when working with Intertek you can expect benefits including 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 EUT (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. This position outline is a general guideline and does not represent all encompassing details. The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties. 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 legislation, marijuana may be included in that screening. Intertek’s network of phenomenal people are our greatest assets, and the diversity they bring fuels our success. Intertek is an Equal Employment Opportunity Employer that values inclusion and diversity. We take affirmative action to ensure all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other legally protected characteristics. For individuals with disabilities who would like to request accommodation, or who need assistance applying, please email [email protected] or call 1-877-694-8543 (option #5) to speak with a member of the HR Department. Intertek does not accept unsolicited approaches from agencies and will not pay a fee for any placement resulting from the receipt of an unsolicited resume. Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification (ATIC) solutions for our customers' operations and supply chains. Working at Intertek means joining a global network of state-of-the-art facilities and passionate people who deliver superior customer service with a purpose of bringing quality, safety, and sustainability to life.

Requirements

Bachelor’s degree in Engineering, Materials Science and Engineering or related field of study
3 years’ experience as a Process Integration Engineer, Quality Assurance Engineer, Undergraduate Research Assistant or related role where required experience gained
Independently conducting on and off-site evaluations of products to determine compliance with applicable standards
Determining applicability of national codes and standards clauses for the EUT
Laboratory testing skills such as using test equipment, following protocols, developing test plans and documentation and reporting
Managing projects for key medical clients resulting in Net Promoter Scores of 70+ and repeat business secured from said client
Meeting additional 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 but not limited to IEC 61010 and 60601
Defining problems, collecting data, establishing facts and drawing valid conclusions
Interpreting an extensive variety of technical instructions in mathematical or diagram form
Analyzing abstract and concrete variables
Making technical decisions and engineering judgments independently within established parameters
Working 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.

Responsibilities

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 EUT (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.