Location: Bedford, MA (Onsite – 5 days/week)
Employment Type: Contract (Hourly)
Duration: Ongoing, project-based
Compensation: $68–$72/hour
Job Summary
Drive the technical development of ophthalmic drug delivery medical devices and associated packaging systems. This position emphasizes mechanical design, risk assessment, verification and validation activities, and support for clinical trial manufacturing of combination products.
Key Responsibilities
Design mechanical components and packaging for medical devices
Conduct DFMEA and UFMEA risk assessments
Lead design verification, validation, and feasibility studies including prototyping and laboratory testing
Work closely with quality, regulatory, human factors, and manufacturing teams as well as external suppliers
Prepare technical documentation to meet FDA, EU, and ISO requirements
Create test protocols, reports, and documentation capturing product and process knowledge
Communicate project plans, progress, and milestones to cross-functional teams and leadership
Qualifications
Bachelor’s degree (advanced degree preferred) in Mechanical, Biomedical, or related engineering
8+ years in medical device design, development, and testing
Strong knowledge of design controls, product realization, ISO 13485, ISO 14971, and IEC 62366
Proficiency in 3D modeling software (SolidWorks/ProE) and GD&T practices
Experience with capital projects, DoE, statistical methods, and technical transfers
Excellent written/verbal communication, data analysis, and problem-solving skills
Self-motivated team player able to handle ambiguous challenges in cross-functional environments
What We Offer
Competitive senior engineering contract rates
Hands-on impact on combination product development
Platform resources and collaboration tools
How to Apply
To apply, visit our career portal and complete the quick and straightforward application process: enter your details, upload your CV, add your LinkedIn (optional), answer a few qualifying questions.
(Or visit: https://www.pharmasmarket.com/signup/talent)