Development Quality Engineer II

This position will support a new product development project and support completion of design control deliverables.

Primary work will include design verification/design validation master plans, test method validation, writing design verification protocols, coordinating sample builds and testing, analyzing test results, writing design verification reports, updating FMEAs and other risk documentation and maintaining traceability documentation.

Required Qualifications:

• Bachelor's degree within an Engineering field or related science-based discipline.
• 2-5 years of related work experience.
• Previous Quality engineering experience and demonstrated use of Quality tools/methodologies.
• Medical device/FDA industry background.
• Experience with Design Controls, design validation/verification, design assurance, risk management process etc.
• Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

Preferred:

• Advance degree preferred.
• Experience with ISO 13485, ISO 14971, EU-MDR is highly preferred.

As an equal opportunity employer, ICONMA prides itself on creating an employment environment that supports and encourages the abilities of all persons regardless of race, color, gender, age, sexual orientation, citizenship, or disability.