Biomedical Engineer

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 Power Point .
• 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."