Manager, Engineering - R&D
ICU MedicalAbout the role
Position Summary
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.
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 S
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