Collabera · 4 hours ago
Product Development Engineer
North Chicago, IL
Contract
Onsite
Entry, Mid Level
$35/hr - $40/hr
1+ years expCollabera is a company in the Pharmaceutical industry, seeking a Product Development Engineer to support the design, development, testing, and scale-up of medical devices and drug delivery systems. The role involves laboratory experimentation, product and process development, and collaboration with various teams to ensure manufacturing readiness.
ConsultingInformation ServicesInformation Technology
Hiring Manager
Deepak Arya
Responsibilities
Support product development activities from laboratory scale through commercial manufacturing
Design and execute laboratory studies for medical devices and combination products
Conduct design of experiments to evaluate product functionality reliability and manufacturability
Perform data analysis summarize results and prepare technical reports and presentations
Support design verification and design validation testing activities
Develop experimental protocols test methods and investigation plans
Participate in risk assessments and creation of test plans based on risk priorities
Support technology transfer process development and scale up activities
Collaborate with cross functional teams including quality regulatory manufacturing and supply chain
Support interactions with contract manufacturing organizations
Troubleshoot manufacturing and process challenges and support investigations
Prepare and review technical documentation including SOPs batch records and validation protocols
Stay current with industry trends and best practices in pharmaceutical and medical device development
Qualification
Required
Bachelors degree in Biomedical Mechanical Chemical Materials Science Pharmaceutical or related Engineering field
One to five years of hands on experience in product development for medical devices drug delivery systems or combination products
Laboratory experience supporting product development and manufacturing processes
Hands on experience with biomedical and mechanical design development and lab testing
Experience with drug product stability and chemical reactions in primary containers
Product development experience with knowledge of commercial scale manufacturing
Strong understanding of medical device or pharmaceutical product development
Experience conducting design of experiments product testing and data analysis
Excellent technical writing data summarization and presentation skills
Preferred
Masters or Doctoral degree in Engineering or related field
Experience with electro mechanical pump devices
Experience with prefilled syringes cartridges auto injectors eye care devices or pumps
Familiarity with FDA ISO standards and design history file documentation
Knowledge of cGMP environments and regulatory requirements
Experience in human factors usability studies and design controls
Formal project management experience
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term disability insurance
Short-term disability insurance
Paid parking/public transportation
(paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)
Company
Collabera
Collabera is an end-to-end information technology services and solutions provider helping clients align their business and IT strategies.
10001+ employees
H1B Sponsorship
Collabera has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (141)
2024 (93)
2023 (120)
2022 (186)
2021 (180)
2020 (146)
Funding
Current Stage
Late StageTotal Funding
$30M2006-05-04Series Unknown· $30M
Leadership Team
Lalit Sharma
CFO
Michael H. Abraham
Chief Financial Officer
Recent News
2024-04-09
2023-01-20
2022-04-19
Company data provided by crunchbase