At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow's challenges. If you'd like to join a high-reward, truly inspiring environment with an experienced, diverse team working at their best every day, and take your career to the next level, apply today!
We are looking for an experienced and highly motivated Principal Design Quality Engineer to join our Quality Assurance team and help us develop and demonstrate exciting technologies from ideation through clinical trials. We truly understand the need for balance and, among other things and offer a 9/80 schedule with every other Friday off. That's 26 long weekends a year!
Position summary:
The Principal Design Quality Engineer will lead Quality Engineering function to support design development activities assuring products and processes meet the customer, internal and regulatory requirements. You will represent Quality Assurance on new product development projects while working closely with R&D and other core team members to create and support design control deliverables, lead risk analysis activities, analyze data, apply quality engineering best practices, and creation of technical documentation supporting early feasibility clinical trials. This role is also engaged in working closely with Manufacturing to plan and execute pilot production activities for clinical trials.
Main responsibilities:
Lead risk management activities, including the creation and maintenance of risk management documentation, such as FMEAs, hazard analysis, plans, reports, and trace matrices in accordance with ISO 14971 and cybersecurity requirements.
Actively support the creation and approval of technical documentation for medical devices, specifically, implantable medical systems, including Requirements, Specifications, V&V plans, reports, and manufacturing documentation.
Represent the Quality Organization on Product Development teams. Support the design control activities required for early design feasibility studies design. Provide critical feedback to project teams during the document review and approval process.
Develop quality assurance specifications, inspection procedures, test methods, sampling plans and written procedures.
Prepare technical documentation to support design control activities and regulatory submissions.
Collaborate with R&D and Manufacturing Engineering in the creation of design and manufacturing documentation to establish the pilot production processes and procedures required to support early feasibility studies.
Drive improvements in quality system processes and procedures.
Support the assigned CAPA and supplier quality activities by implementing effective solutions
Education/Experience:
Bachelor's degree and 8+ years of experience in the medical device industry, Class III preferred
Demonstrated command and knowledge of FDA and ISO medical device quality system requirements (21CFR820, ISO 13485, and ISO 14971) and audit programs (MDSAP)
Demonstrated ability to support multiple projects.
Experienced leading design assurance activities for new product development.
Proficient computer skills including MS Word, Excel, Teams, Outlook, and statistical software (e.g., MiniTab, Design of Experiment DOE, etc.)