Collabera · 2 hours ago
Product Development Engineer-Medical Devices/ Drug Delivery Systems/ Combination products
Collabera is focused on innovative solutions in the medical field, and they are seeking a Product Development Engineer to support the development and scale up of medical devices and drug delivery systems. This role involves laboratory execution, experimental design, and collaboration with cross-functional teams to ensure successful product verification and manufacturing readiness.
Responsibilities
Provide technical support for product development and laboratory scale up for medical devices and combination products
Plan, design, execute, document, and analyze verification and validation testing activities
Conduct design of experiments and functional testing to assess product performance and reliability
Generate and summarize experimental data and prepare technical reports and slide presentations
Support technology transfer, process development, optimization, and scale up activities
Collaborate with cross functional teams including quality, regulatory, manufacturing, and supply chain
Interface with contract manufacturing partners to ensure technical and operational alignment
Assess risks, create test plans, analyze results, and document conclusions for compliance purposes
Develop and review technical documentation including standard operating procedures and validation protocols
Troubleshoot manufacturing challenges and support investigations related to deviations or process failures
Qualification
Required
Bachelor's degree in biomedical engineering, mechanical engineering, chemical engineering, materials science, biotechnology, or a related field
Experience in developing medical devices, drug delivery systems, or combination products
Hands on laboratory experience in product design, development, testing, and characterization
Knowledge of design verification, design validation, and usability applications
Understanding of commercial scale manufacturing processes for pharmaceutical or medical device products
Familiarity with regulatory and quality requirements including design controls and documentation
Strong technical writing, data analysis, and presentation skills
Excellent problem solving, communication, and collaboration abilities
Preferred
Master's degree or Doctorate in a relevant engineering or scientific discipline
Experience with electromechanical pump devices, primary containers, or drug delivery platforms
Knowledge of pre filled syringes, cartridges, auto injectors, eye care devices, or pumps
Experience with technology transfer, process validation, and contract manufacturing organizations
Familiarity with FDA and ISO standards and design history file documentation
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 off
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.
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
Recent News
2024-04-09
2023-01-20
2022-04-19
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