Test Engineer (NPD & On-Market Support)

Ecomed Solutions is currently seeking a Test Engineer to join its team in Lindenhurst, IL (60046).

WHO WE ARE:
Ecomed Solutions is a rapidly growing medical device company dedicated to creating a healthier future through the manufacture and supply of high-quality products and consumables. Our innovative portfolio delivers essential solutions across Diagnostic Imaging, Blood Management, Infusion Therapy, and the Veterinary and Animal Care markets. Trusted by clinicians and healthcare providers worldwide, we combine quality and reliability with a customer-first mindset to provide a true one-stop solution for our partners.
At Ecomed Solutions, our success is built on collaboration, integrity, and the ability to deliver meaningful value to the patients and providers who rely on us every day. We are looking for result-driven individuals who are passionate about quality and reliability and ready to grow with a leader in medical device innovation. Join our team and be part of a company making a real impact on the global healthcare landscape.

ABOUT THE ROLE:
The Test Engineer is a versatile role responsible for supporting the technical execution of New Product Development (NPD) and on-market product support. The role demands a balance of hands-on laboratory testing, root-cause analysis of field complaints, and authorship of formal engineering documentation within a highly regulated medical device environment.
Location: On-Site (Lindenhurst, IL), five days per week
Reports to: Director, Engineering & Development
Travel: Negligible (< 1%)
Physical Demands:
Lifting: Occasionally required to lift and/or move up to 50 pounds.
Dexterity: Frequently required to utilize hand and finger dexterity for small component evaluation, fixture assembly, etc.
Postures: Continually required to sit for prolonged periods (documentations/analysis); occasionally required to stand for prolonged periods (lab execution).

KEY RESPONSIBILITIES:
New Product Development (NPD)
Test Execution: Perform functional testing (e.g., tensile, leak, and flow characterization) for new IV consumables and delivery systems. Testing shall be documented in a laboratory notebook following Good Documentation Practices. Coordinate testing with suppliers and external test labs.
Test Method Design & Test Strategy: Develop novel test methods and custom fixtures as required. Procure test supplies and samples. Assist in developing efficient test plans that minimize cost and lead time while ensuring compliance and statistical relevance.
Technical Documentation: Author Product Specifications, Change Control forms, Verification Plans, Test Protocols, and Verification Summary Reports.
On-Market Support & Complaint Investigation
Defect Evaluation: Conduct physical evaluations of returned defect samples and analyze clinical photographs to identify failure modes.
Root Cause Analysis: Support formal investigations into product performance issues, collaborating with Quality and Manufacturing teams to determine if failures are due to design, material, process deviations, or user error.
Investigation Reporting: Draft comprehensive Complaint Investigation Reports that clearly document findings, testing data, and conclusions. Maintain the Complaint Log including complaint closure and entry of new complaints.
Statistical Analysis: Use statistical tools to identify trends in complaint data and document defect rates.

WHAT WE OFFER:
A high-impact role within the rapidly growing medical device manufacturer.
Competitive salary and a comprehensive benefits package available on day one, featuring medical, dental, life insurance, and a retirement savings program with a company contribution.
Hands-on medical device engineering training and exposure to broader organization functions.
A clear path for professional development supported by direct mentorship and continuous learning opportunities.

QUALIFICATIONS:
Education & Experience
Required: Associate’s Degree in a related technical discipline paired with 1-3 years of experience in an engineering or laboratory setting.
Preferred: Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline with 1 year of experience (Open to high-potential new graduates).
Technical Skills
Analytical Mindset: Ability to look at a failed component and logically "reverse-engineer" the sequence of events that led to the defect.
Mechanical Aptitude: Proficiency with lab equipment (calipers, gauge pins, pressure gauges, force gauges, scales).
Technical Writing: Strong ability to draft clear, objective, and evidence-based reports that can withstand regulatory audits (FDA/ISO).
Software Proficiency: Skilled in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) for data analysis and reporting.
Competencies
Teamwork: Balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests.
Quality: Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
Dependability: Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; completes tasks on time or notifies appropriate person with an alternate plan.
Professionalism: Approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
General Requirements
Willingness to perform other related duties as assigned to support departmental, cross-functional, or organizational goals. Responsibilities may evolve based on business needs and team priorities.
Valid driver's license and acceptable background check.
Must be legally authorized to work in the United States without the need for employer sponsorship.
Plus Factors
Prior medical device, combination products, or pharmaceutical industry experience.
Familiarity with Good Documentation Practices (GDP).
Basic knowledge of Quality Management Systems (ISO 13485) and Risk Management (ISO 14971).
Experience with Root Cause Analysis tools (e.g., Fishbone diagrams, 5 Whys, or Failure Mode and Effects Analysis).

Ecomed Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, disability, age, genetic information, veteran status, or any other protected characteristic under applicable laws.
Show more Show less