Sr. Development Quality Engineer

Description

The Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety customer satisfaction and organizational success.

RESPONSIBILITIES

- Lead and/or support on-time completion of Design Control deliverables

- Support the establishment of objective measurable and verifiable product requirements

- Support Design Verification and Validation planning execution including any cross-functional investigation resolution activities

- Lead Risk Management activities from product concept through commercialization

- Support test method development and lead test method validation activities

- Support manufacturing process development qualification for new product and design changes

- Support the establishment of component specification definitions supplied component sampling plan development and vendor qualifications

- Support biocompatibility and sterilization qualifications

- Support audits and quality system improvement activities

- Support Company initiatives as identified by management and in support of Quality Management Systems QMS Environmental Management Systems EMS and regulatory requirements.

- Comply with U.S. FDA EUMDR and other requirements as applicable.

- Maintain positive and cooperative communications and collaboration with all levels of employees customers contractors and suppliers.

Basic Qualifications:

- Bachelors degree in Engineering or Technical Field.

- Minimum of 5 years of experience in RD Process/Manufacturing Engineering and/or Quality with at least 2 years supporting product development.

- Experience in medical devices and associated regulations/standards.

- Experience in test method development and validation

- Experience in preparing risk assessments FMEA and other risk documents.

Preferred Qualifications:

- Advanced Degree in Engineering/Technical Field

- Experience in active implantable medical devices.

- Knowledge of requirements management tools e.g. DOORS and use of problem reporting systems e.g. JIRA.

- Working knowledge of statistics and its application to verification and validation?

Skills

medical device, quality engineering, quality assurance

Experience Level

Expert Level