Biomedical Engineer

Mindlance; North Chicago (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

Mindlance is seeking product development engineers to support the development, testing, manufacturing, and scale-up of medical devices, drug-device delivery systems, and combination products. The role focuses on laboratory studies, DOE, product characterization, design verification/validation, process development, troubleshooting, and technical documentation.

Responsibilities include designing and executing DOE and reliability tests, supporting technology transfer and scale-up, and preparing

Qualifications

• BS degree in Biomedical, Mechanical, Chemical, or related engineering.
• Experience with medical devices or drug-device products.
• Laboratory experience in product development and manufacturing.
• Experience with DOE, testing, characterization, and data analysis.
• Knowledge of product/process development for commercial scale.

Responsibilities

• Design and execute DOE, functional, reliability, and characterization testing for medical devices and combination products.
• Support product and process development, optimization, technology transfer, scale-up, and commercial manufacturing.
• Plan, execute, document, and analyze laboratory experiments and testing programs.
• Analyze data, summarize results, prepare technical reports and PowerPoint presentations, and present findings to cross-functional teams.
• Develop and review SOPs, test protocols, validation documentation, and technical reports.
• Support manufacturing investigations, troubleshooting, deviations, and process failures.
• Collaborate with Quality, Regulatory, Marketing, Supply Chain, CMOs, and other cross-functional teams.
• Apply FDA, ISO, cGMP, design control, design verification, and design validation requirements.

Skills

DOE testing

Lab testing

Data analysis

Technical writing

Presentation

Cross-functional

Problem solving

Independent work

Manufacturing processes

Education

Biomedical/Mechanical/Chemical or related engineering

MS/PhD preferred

Tools

PowerPoint

Word

Excel

Job description

Duration: 12+ Months Contracts (possible extension)

Job Summary:

The client is seeking product development engineers to support the development, testing, manufacturing, and scale-up of medical devices, drug-device delivery systems, and combination products. The role will focus on laboratory studies, DOE, product characterization, design verification/validation, process development, troubleshooting, and technical documentation.

Key Responsibilities:

• Design and execute DOE, functional, reliability, and characterization testing for medical devices and combination products.
• Support product and process development, optimization, technology transfer, scale-up, and commercial manufacturing.
• Plan, execute, document, and analyze laboratory experiments and testing programs.
• Analyze data, summarize results, prepare technical reports and PowerPoint presentations, and present findings to cross-functional teams.
• Develop and review SOPs, test protocols, validation documentation, and technical reports.
• Support manufacturing investigations, troubleshooting, deviations, and process failures.
• Collaborate with Quality, Regulatory, Marketing, Supply Chain, CMOs, and other cross-functional teams.
• Apply applicable FDA, ISO, cGMP, design control, design verification, and design validation requirements.

Required Qualifications:

• BS degree in Biomedical, Mechanical, Chemical, Materials Science, Biotechnology, Pharmaceutical Engineering, or a related engineering field.
• Experience with medical devices, drug-device delivery systems, and/or combination products.
• Hands-on laboratory experience with product development and manufacturing processes.
• Experience with DOE, product testing, characterization, and data analysis.
• Knowledge of product/process development and commercial-scale manufacturing.
• Strong technical writing, communication, problem-solving, and presentation skills.
• Ability to work independently and effectively in a fast-paced environment.

Preferred Qualifications:

• MS or PhD in a relevant engineering/scientific discipline.
• Experience with electromechanical pump devices, pre-filled syringes, cartridges, auto-injectors, eye-care devices, or drug delivery systems.
• Knowledge of technology transfer, process validation, analytical methods, and process characterization.
• Experience working with CMOs.
• Familiarity with electronic notebooks, Word, Excel, and PowerPoint.
• Knowledge of FDA/EMA regulations, ISO standards, design history files, and human factors/usability studies.

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."