Sr. Design Quality Engineer

What You'll Do

• The responsibilities listed below are representative of the position and are not intended to be an exhaustive list of all duties that may be assigned.
• Execute quality assurance activities throughout product design and development in accordance with applicable regulations, standards, and company procedures.
• Support the development, maintenance, and review of design control deliverables.
• Support implementation and maintenance of the electronic Quality Management System (eQMS), including management of design inputs, risk management documentation, and other quality and product records.
• Author, review, and drive verification and validation activities, including protocols, reports, and closure documentation.
• Author and/or support test method validation activities, including Gauge R&R studies, Attribute Agreement Analysis, and software tool validation.
• Author, review, and drive risk management activities, including Risk Management Plans, Hazard Analyses, FMEAs, and Risk Management Reports.
• Collaborate with cross-functional teams to ensure design control activities are executed in accordance with company procedures and applicable regulatory requirements.
• Support Quality Management System (QMS) compliance, continuous improvement initiatives, and audit readiness activities.
• Support compliance activities related to medical device software lifecycle processes (IEC 62304) and usability engineering (IEC 62366-1).
• Work effectively within small, cross-functional teams while managing multiple priorities and assignments.
• Travel up to 10% as required.
• Education, Experience and Background Requirements Bachelor’s degree in Engineering, Life Sciences, or a related technical field. 7+ years of experience in Quality Engineering, Design Quality Engineering, or product development quality roles within the medical device industry.
• Strong experience supporting design controls, risk management, and verification & validation activities.
• Experience working in a startup or fast-paced product development environment preferred.
• For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S.
• Department of Commerce - Bureau of Industry and Security and/or the U.S.
• Department of State - Directorate of Defense Trade Controls.
• As such, applicants for this position – except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) – may have to go through an export licensing review process.
• We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.
• EEO is the Law: Notice of Applicant Rights Under the Law .
• Job Req Type: Experienced Required Travel: Yes, 10% of the time Shift Type: 1st Shift/Days The expected wage range for a new hire into this position is $95,600 to $131,450.
• Actual wage offered may vary depending on work location , experience, education, training, external market data, internal pay equity, or other bona fide factors.
• This position qualifies for a discretionary performance-based bonus which is based on personal and company factors.
• This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time , and other benefits.