5+ years of experience in medical device industry focused on New Product Development (NPD) Engineering and Design Quality.
Strong creative, analytical, and problem-solving skills.
Experience observing and understanding manufacturing processes.
Proficient in using PC applications, including word processing, presentation software, and spreadsheets.
Good knowledge of validation processes (IQ, OQ & PQ).
Ability to read and interpret engineering drawings, GD&T, and schematics.
Preferred in-depth knowledge of medical device design.
Responsibilities
Collaborate effectively with globally located cross-functional teams to meet project requirements.
Drive and support design quality activities across multiple new product development projects.
Complete and approve verification and validation activities.
Conduct validation for Time Savor Fluid change and new Silkscreen ink.
Create, update, and review risk management reports and DFMEAs.
Benefits
Opportunity to work on innovative medical device projects.
On-site position fostering collaboration and teamwork in Warsaw, IN.
Exposure to global client networks and cross-functional teams.
Full Job Description
Role : Design Quality Engineer Location: Warsaw, IN (On-Site)
Must have Medical Devices Exp.
Job Description:-
Strong creative, analytical and problem-solving skills.
Process experience, ability to observe and understand manufacturing processes.
Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)
Good experience in Validation (IQ, OQ & PQ).
Ability to read engineering drawings, GD&T, terminology, schematics.
In-depth knowledge of design of medical devices preferred.
Roles & Responsibilities:
The candidate will need to have effective communication skills and be a team player to work with globally located client cross-functional teams to execute and deliver as per projects requirements.
The candidate will be responsible for the following.
Driving and supporting design quality activities for multiple new product development projects
Completing and approving verification and validation activities.
Time Savor Fluid change validation, New Silkscreen ink
