Electrical Engineer

Job Description

The Urology R&D organization is seeking a highly skilled and motivated Electrical Engineer, with a focus in Test Method Validation to support an acquisition and integration project for a duration of 9 months, with the option to extend.

In this role, you will be responsible for creating, validating, and documenting test methods for electrical and medical electrical equipment, ensuring compliance with work instructions, SOPs, and applicable standards. A major focus of this position is test method development and validation, including the creation of approximately 60 test method protocols, execution or oversight of validation activities, and preparation of final technical reports. This role will assess acquired company test methods to determine validation needs, perform or coordinate validation testing (e.g., Gauge R&R), and update documentation to justify when validation testing is not required. You will also support technician scheduling and training, perform statistical data analysis using Minitab, and generate final validation and engineering reports.

As a key team member, you will provide technical testing solutions and engineering support under guidance from subject matter experts, applying your background in electrical/systems engineering, test method design, test method validation, verification testing, and statistical analysis.

Test Method Development & Validation

-Develop, write, and maintain test method protocols, with an expected workload of approximately 60 test method protocols during the project.

-Create new test methods and improve existing methods for electrical and medical electrical equipment.

-Perform and/or oversee test method validation activities, including Gauge R&R and other statistical validation techniques, to ensure compliance with Boston Scientific standards.

-Assess acquired company test methods to determine whether validation is required and either execute appropriate validation testing, or update technical documentation with a sound engineering rationale when validation is not required.

-Identify gaps in test method validation compliance and define strategies to close those gaps.

Testing Execution & Technical Support

-Provide hands-on technical support for verification and validation testing activities.

-Assess feasibility and soundness of alternative test methods, engineering processes, products, or equipment.

-Complete complex or novel assignments requiring the development of new or improved testing techniques and procedures.

-Support efficient and effective integration of acquired medical device technologies into the Boston Scientific portfolio.

Technician Coordination & Training

-Assist with scheduling test technicians to support validation and verification activities.

Ensure technicians are properly trained on test methods, protocols, and procedures.

Provide technical guidance to technicians during test execution.

Data Analysis & Reporting

-Perform statistical data analysis using Minitab, including Gauge R&R and process capability studies.

-Analyze test results, draw conclusions, and make engineering recommendations based on data from multiple sources.

-Write clear, concise final reports, including test method validation reports and technical summaries.

Complete high-quality engineering documentation in accordance with Boston Scientific quality systems.

Communication & Project Support

-Provide input to project goals, timelines, and progress.

-Communicate technical progress, risks, and trade-offs to project leadership.

-Recommend revisions to testing strategies, documentation, or plans as needed.

-Demonstrate strong knowledge of Technology Development and Product Development systems through delivery of high-impact deliverables.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

-BS or higher in Electrical Engineering or a related field

-4+ years of engineering experience with a Bachelor's degree, or 2+ years with a Master's degree

-Strong background in test method development and test method validation, particularly for electrical or medical electrical equipment

-General knowledge and hands-on experience creating test methods from concept through validation

-Strong electrical and/or systems engineering skills with high attention to detail

-Ability to analyze technical data, draw conclusions, and make sound engineering recommendations

-Experience writing test protocols, validation documentation, and final reports

-Strong written and verbal communication, judgment, decision-making, collaboration, and critical thinking skills

-Personal drive, accountability, and a strong bias for action

Willingness to travel up to 10%

-Ability to work onsite a minimum of 3 days per week at the Arden Hills, MN location -Experience validating test methods for electrical equipment and medical devices

-Familiarity with IEC 60601 Medical Electrical Equipment standards, including laser-specific sections

-Familiarity with IEC 14708 and IEC 45502 Active Implantable standards

-Experience with Gauge R&R, process capability studies, and Minitab

-Experience with single-use devices or active implantable devices

-Experience coordinating or supporting technician teams

-Ability to build strong relationships across cross-functional teams and with external stakeholders