Sr Design Quality Engineer

Additional details from the hiring manager.

About the role

This role is a member of the Design Quality team supporting Global Quality (GOSC) efficiency projects across multiple products in Neuromodulation and Pelvic Health. The target experience range is 5–7 years, depending on education and background.

Top skills required

• General quality experience in the medical-device industry
• Design Assurance / Design Quality expertise
• Self-driven, independent ability to engage with cross-functional teams and manage multiple project workloads
• Lean / Six Sigma project-improvement experience

Responsibilities

• Serve as the quality-lead representative on global quality-improvement, cost-down, and efficiency projects
• Engage in, review, and approve design-control and qualification deliverables, protocols, and processes
• Ensure products and quality processes maintain regulatory compliance while achieving cost-down and efficiency targets
• Develop, modify, apply, and maintain quality standards and protocols for processing materials into finished or partially finished product
• Collaborate with engineering and manufacturing functions to establish and uphold quality standards
• Devise and implement inspection and testing methods and procedures for products and production equipment
• Design or specify inspection and testing mechanisms and equipment; conduct quality-assurance tests
• Perform statistical analysis to assess the cost of and assign responsibility for products or materials that do not meet required standards
• Ensure corrective measures meet acceptable reliability standards and that documentation complies with requirements
• May specialize in design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality

Qualifications

• University degree (advanced degree preferred)
• Minimum of 4 years of relevant experience (2 years if holding an advanced degree)
• Advanced knowledge of job area, combining breadth and depth, typically obtained through education and experience
• Practical knowledge of project management

Differentiating factors

• Autonomy: Seasoned individual contributor who works independently under limited supervision, determines approach to solutions, and coaches or reviews the work of lower-level specialists; may manage projects or processes.
• Organizational Impact: Responsible for entire projects or processes within the job area; contributes to work-group objectives by building relationships and consensus.
• Innovation & Complexity: Tackles difficult problems that may span multiple issues, job areas, or specialties; provides in-depth analysis and recommends process improvements.
• Communication & Influence: Communicates with senior internal and external customers and vendors to exchange information, influence decision-making, and achieve objectives.
• Leadership & Talent Management: May provide guidance, coaching, and training to other employees; may delegate work and review others’ work products.