The Manager, Engineering - R&D Hardware Testing will oversee the daily operations of our state-of-the-art R&D hardware test lab, ensuring the efficient and accurate testing of medical device products. This is an onsite role that offers the opportunity to work with cutting-edge technology and make a significant impact on the development of life-saving medical devices. Work in an innovative environment, enjoy career growth opportunities, and play a key role in ensuring the safety and efficacy of medical devices that improve patient outcomes. Join a team of dedicated professionals who are passionate about making a difference.
Essential Duties & Responsibilities
Lead all operational aspects of our R&D hardware engineering lab by working closely with all users to maintain safe, compliant, clean, organized, and efficient lab spaces.
Own and maintain R&D lab safety and operating procedures while also ensuring compliance.
Ensure all equipment is maintained, calibrated and in compliance with lab operating procedures.
Support basic electrical and mechanical prototype assembly, debug, and modification.
Oversee all testing performed in the R&D lab, including direct supervision of lab technicians.
Collaborate with design and engineering teams to support product development, ensuring thorough documentation of testing and analysis of test data.
Prioritize lab work requests, allocate technician resources, and manage lab inventory and space.
Plan, execute, and report on product certification testing performed at external labs.
Troubleshoot product failures.
Lead consolidation of hardware test activities to the Lake Forest site and support all hardware test activities, including those requested by other global sites.
Manage product design releases in Agile PLM.
Train and mentor lab staff on best practices and safety procedures.
Knowledge, Skills & Qualifications
This role will require significant collaboration with cross functional R&D leaders and engineering peers to ensure proper prioritization and execution of product testing needs.
Strong understanding of hardware testing methodologies and tools.
Familiarity with safety-critical medical device standards and regulations (e.g., ISO 13485, IEC 60601-1, etc.).
Excellent organizational and project management skills.
Ability to analyze complex data and generate clear, concise reports.
Strong leadership and team management abilities.
Proficiency in using lab management software and tools.
Excellent communication and interpersonal skills.
Minimum Qualifications, Education & Experience
Must be at least 18 years of age
Bachelor's degree in Electrical Engineering or a related field.
Minimum of 8 years of experience in a hardware testing environment, preferably within the medical device industry.
Previous experience in a supervisory or managerial role is highly desirable.
Certification in relevant quality and safety standards is a plus.
Work Environment
This role requires being onsite full time.
This job operates in a professional office environment including an electrical engineering laboratory.
While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the test equipment they are using
Must be able to occasionally move and lift objects of up to 25 lbs and willing to transport equipment to 3rd party EMC labs for testing purposes.
Typically requires travel 5-10% of the time
Salary Range - $120,000 - $172,000
The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.
About Us
ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.
With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.
We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:
Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
Significant US IV solutions manufacturing and supply capabilities.
ICU Medical EEO Statement:
ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.