Job Details
Join Our Team as a Senior Quality Design Engineer!
Are you passionate about ensuring products meet the highest standards of quality and design excellence? Do you thrive in a dynamic environment where innovation is key? Career Management Group is partnered with a leading company that manufactures and distributes medical equipment serving the respiratory, sleep and cardiology patients, caregivers, physicians, and providers. We are looking for a talented Senior Quality Design Engineer to join our team and play a pivotal role in driving quality assurance initiatives from conception to implementation.
We're dedicated to pushing the boundaries of what's possible, creating products that make a real difference in people's lives. As a Senior Quality Design Engineer, you'll be at the forefront of this mission, working collaboratively with cross-functional teams to develop and maintain rigorous quality standards throughout the product lifecycle.
Qualifications:
- 7+ years of experience or equivalent experience in Medical Device Design control and the application of ISO14971, 21CFR820, ISO13485, IEC62304, IEC 62366, IEC 60601.
- Experience with new design (NPD), design transfer, design changes and sustaining of mechanical and software driven devices.
- Experience with test method development and the validation of those test methods.
- Experience with risk management file creation and updates.
- Bachelor s degree in engineering, life sciences or related field.
Preferred Education:
- Master's degree in engineering or life sciences discipline.
Preferred Experience:
- Experience working with electronic circuit boards and cable assemblies.
- DHF (Design History File) remediation when moving from one design control system to another.
- EUMDR (European Medical Device Regulation).
- Design for Six Sigma.
- House of Quality.
- Familiarity with electronic quality management systems.
- Excellent written/oral communication skills required. Must be able to work effectively with diverse groups of people.
Duties and Essential Functions:
Each Employee consistently demonstrates the following essential functions:
- Initiate, review and/or approve Engineering Change Orders.
- Perform and document design controls for new products.
- Develop and maintain risk management files.
- Support specification development.
- Identify and implement improvements to the design control program.
- Coordinate and perform test method validation testing.
- Support verification and validation testing.
- Applies statistics to make business decisions.
- Ability to conduct failure investigation and root cause analysis.
- Identify and implement improvements to QMS.
- May support internal audits to verify compliance with procedures.
- Participate in, and support of, external regulatory audits and inspections.
- Attends and participates in departmental meetings.
- Attends seminars and training sessions necessary to maintain appropriate level of professional competence.
- Ensures all department compliance guidelines are met.
- Attends all meetings, in-services training, or continuing education as delegated by the supervisor. Provides customer focused interactions.
- Performs all duties necessary for the department as per department policies and procedures.
- Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department.
Why Join Us?
- Opportunity to work on cutting-edge projects and make a real impact.
- Dynamic and collaborative work environment where your ideas are valued.
- Competitive compensation package and comprehensive benefits.
- Career development and growth opportunities.
- Potential performance-based bonus and/or signing bonus.
If you're ready to take your career to the next level and make a meaningful contribution to our team, we'd love to hear from you! Apply now to join us as a Senior Quality Design Engineer and help shape the future of our products.