Duties require on-site activity (Franklin Lakes NJ) 2-3 days per week. Will consider applicants outside of local area if they are able to relocate to NJ within 2 weeks.
Roles & Responsibilities
Duties & Responsibilities
Contribute to planning through all project phases with a focus on the change control strategy, development of design verification strategies, and execution of said strategies
Support technical gap assessments, development of remediation plans, and execution of said plans
Craft, edit, and interpret technical drawings and write protocols, reports, work instructions, presentations, etc.
Apply engineering principles for design/analysis and complete statistical analysis and sample plan development.
Demonstrate accountability for the successful and timely achievement of goals.
Experience Required
Education & Experience
Minimum 3 years of experience in medical device or other regulated industry
Experience with design controls activities and change management including DHF documentation is required
Experience with technical gap assessments and remediation strategy development / execution is required
Experience with test method development, validation strategy, and execution is required.
Experience with design verification strategy development and execution is required
Proficiency in solid mechanics/mechanics of materials and experience to statistical methods / tools is required.
Experience in solid modeling (SolidWorks or equivalent) is desirable
Skills & Certifications
Work independently with minimal guidance to complete objectives assigned by project team
Eligibilities & Qualifications
Bachelors Degree
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