Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, efficiency, change, and outcomes.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
What you will do
As a Senior Design Assurance Engineer, you will support New Product Development (NPD) Design Assurance Engineering activities for orthopedic medical devices, with a primary focus on risk management, usability engineering, design control documentation, and the transition of risk management content from Integrity to Jama. This role may also support active NPD programs and related design assurance activities based on project and business needs.
This role requires strong technical judgment, the ability to quickly organize and manage work, and clear communication of status, risks, barriers, and next steps. You will engage cross-functionally with Design Assurance, Product Development, Regulatory, Marketing, Operations, and other stakeholders to support compliant and timely execution in a highly regulated environment.
Knowledge of FDA QSRs, ISO 13485 Design Control Procedures, IEC 62366-1, and ISO 14971
Knowledge of EU Medical Device Regulation preferred
- Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poka Yoke.
Experience with risk management, usability engineering, and/or design control documentation within medical device product development
Experience using an application or software system to document, manage, or trace risk management, usability, requirements, or design control information; Jama, Integrity, or similar systems preferred
Ability to support implementation of new systems, tools, or processes in a highly regulated environment
Demonstrated ability to communicate complex plans, technical information, project status, risks, and open actions to team members and stakeholders
Demonstrated ability to independently manage priorities, own assigned deliverables, respond to project needs, and meet deadlines
What you need:
• Bachelor’s Degree in Engineering; Biomedical, Mechanical, or related discipline
• Minimum 2+ years of experience as a Quality Engineer, Design Assurance Engineer, or Engineer in a regulated design environment preferred
• Experience within the medical device product development life cycle highly preferred
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