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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.