Senior Design Engineer

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.