Design Assurance Engineer II

About the role

The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures.

Responsibilities

• Supports new product development to ensure desired design performance meets regulatory requirements.
• Ensures successful transfer of newly developed products to production, supporting design phases from concept to launch.
• Works closely with other departments to coordinate design engineering activities.
• Reviews, initiates, or approves engineering drawings, layouts, changes orders, and specifications.
• Plans process flow, evaluates process capability, modifies tooling, builds tooling, and designs tooling.
• Plans, schedules, conducts, or coordinates detailed phases of engineering work in a part of a major project.
• Develops and/or reviews test procedures and plans prior to implementation, conducts failure analysis, and inspects products, processes, and materials.
• Evaluates, selects, and applies standard engineering techniques and procedures while making minor adaptations and modifications.
• Devises new approaches to problems encountered.
• Prepares all necessary paperwork and documentation for all projects undertaken.
• Embeds Quality within the Engineering discipline.
• Supports Integer’s Manufacturing Excellence and Market Focused Innovation Strategies.
• Champions the development of and deployment of systems and tools to drive innovation and continuous improvement.
• Embraces the Manufacturing Excellence culture based on the Integer Production System and its five focus areas.
• Engages in sustained change by ensuring production monitoring & improvement activities and deployment of Leader Standard Work.
• Standardizes through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs.
• Adopts standardized problem solving methodologies, behavior-based safety programs, and improvement idea and suggestion systems.
• Optimizes systems & processes through adoption of principles of built in quality, optimized scheduling & material system designs, work cell design, and total productive maintenance.

Requirements

• Earned, as a minimum, a Bachelor’s Degree in an engineering or related technical field.
• May have earned a Master’s Degree.
• 3+ years of progressive engineering and/or technically focused roles and experiences.
• Strong technical and problem solving foundation, preferably training and certifications in 6-Sigma (green belt as a minimum, black belt preferred), 8D, RCA, 5-Why, Ishikawa (Fish Bone), Kepner-Tregoe, PMP.
• Ability to observe, analyze, and develop solutions to challenging technical issues resulting in measurable results in productivity, technical capabilities, capacities, or other competitive differentiators.
• Works independently and collaboratively with cross-functional teams.
• Demonstrates leadership in team activities and acts as a coach for other less experienced associates.
• Maintains clear and professional communications to all levels of the organization.
• Possesses a positive, can-do attitude with an underlying belief that failure is not an option.

Qualifications

• U.S. Applicants: Equal Opportunity Employer.
• Veterans and individuals with disabilities are encouraged to apply.