If you would like to be more quickly considered for this position, or if you are interested in hearing about other opportunities I have available in the engineering field please reach out to me directly at [email protected]!

　　Description:

　　Own creation and implementation of all design control deliverables

　　Lead on-time Design Verification and Design Validation (and support Process Validation IQ/OQ/PQ/PPQ) planning & execution

　　Actively participate in and contribute to core team and customer facing meetings

　　Drive meaningful translation of User requirements into discrete, objective, measurable, verifiable, and traceable Product requirements

　　Oversee risk management activities throughout the device life cycle - from product concept through post launch

　　Create accurate and repeatable test & inspection methods

　　Support creation and execution of biocompatibility and sterilization qualifications

　　Analyze data and prepare product test reports

　　Oversee content of the Design History File, its completeness and integrity

　　Ensure component specifications are properly defined and evaluated through the creation of supplied component sampling plans, First Article Inspections, and supplier process qualifications

　　Support supplier management activities and external audits

　　Support external audit and certification efforts conducted by customers and regulatory bodies

　　Support manufacturing lines by resolving components issues or other manufacturing barriers in a timely manner.

　　Oversee and approve document change requests, non-conformances, deviations, and special work order processes

　　Lead root cause analysis and resolution activities

　　Review and approve equipment specifications and qualification activities

　　Develop/coach/mentor Design Quality Engineering Technicians

　　Skills:

　　Design control

　　Design assurance

　　Medical device

　　Dfmea

　　Risk management

　　ISO 13485

　　FDA compliance

　　Process validation

　　Design verification

　　Design validation

　　Design for manufacturing

　　First article inspection

　　Document changes

　　Non-conforming

　　Root cause analysis

　　Audit management

　　Process development

　　Minitab

　　Additional Skills & Qualifications:

　　Demonstrated use of quality tools and methodologies

　　Strong problem-solving proficiency

　　Ability to manage and prioritize multiple tasks and remain focused on personal objectives

　　High attention to detail and accuracy

　　Proven ability to work effectively independently and on a multi-disciplinary team

　　Good understanding of ISO 13485 and FDA QSR

　　ISO 13485 Lead Auditor training and certification

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.