Senior Engineer, Device Development - Ophthalmic Design Expert

Senior Engineer, Device Development - Ophthalmic Design Expert at Pharmas Market Senior Engineer, Device Development - Ophthalmic Design Expert at Pharmas Market in Bedford, Massachusetts Posted in 1 day ago.

Type:

full-time

Job Description:

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 (optional), answer a few qualifying questions. (Or visit: https://www.pharmasmarket.com/signup/talent)