Role & seniority: Senior/Staff level Product Quality Engineer (Sr. Product Quality Engineer)

Stack/tools: Medical device quality systems; design control; test method development/validation; risk management (FMEA); DOORS; JIRA; knowledge of QMS/EMS; regulatory alignment (FDA, EUMDR)

Top 3 responsibilities

Lead and/or support on-time completion of Design Control deliverables and risk management activities from concept to commercialization
Plan, execute and verify Design Verification/Validation; support test method development/validation and cross-functional investigations
Support manufacturing process development/qualification, component specifications, supplier qualifications, biocompatibility/sterilization qualifications, audits, and quality system improvements

Must-have skills

Bachelor's degree in engineering or technical field
5+ years in R&D, Process/Manufacturing Engineering, and/or Quality, with ≥2 years in product development
Experience in medical devices and related regulations/standards
Experience in test method development/validation; experience preparing risk assessments and FMEAs

Nice-to-haves

Advanced degree in engineering/technical field
Experience with active implantable medical devices
Knowledge of requirements management tools (e.g., DOORS) and problem-tracking systems (e.g., JIRA)
Working knowledge of statistics and its application to verification and validation
Location & work type: Not specified; de

Full Description

Job Description

The Sr. Product 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. This individual will be leading and managing a risk management team but could also work on other items. Looking for someone well rounded from a development quality perspective.

Roles & 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 Client, 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.

Requirements

Bachelor's degree in engineering or Technical Field. Minimum of 5 years of experience in R&D, 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.