Senior Engineering Program Director, Quality Strategy – Investigation Excellence

This is a fully remote position, open to applicants in Colorado, +3 more states.

📋 Description

• Establish and spearhead a centralized capability for Investigation Excellence Engineering.

• Formulate an organizational strategy focused on Root Cause Analysis and advanced quality analytics.

• Drive the deployment and governance of sophisticated investigation methodologies, including Shainin Red X, Lean Six-Sigma, and other structured problem-solving techniques.

• Oversee escalation support for critical investigations, major quality incidents, recalls, and CAPAs.

• Create communities of practice and technical career pathways for Quality Reliability Engineers.

• Cultivate and mentor technical experts in investigative disciplines.

• Set standards for investigation quality, analytical rigor, and root cause analysis.

• Collaborate with leaders in Quality, Engineering, Manufacturing, and R&D to identify emerging signals and enhance product performance.

• Promote predictive, data-driven, and proactive quality management practices.

• Plan, direct, and execute the design and development of new medical device products or software systems.

• Develop, assess, implement, and uphold technical quality assurance, control, or reliability systems and standards.

• Supervise the investigation and evaluation of existing technologies.

• Guide the conceptualization of new methodologies, materials, machines, processes, or products.

• Lead the development of new concepts from initial design through to market release.

• Manage feasibility studies for design projects.

• Ensure documentation is maintained throughout the research and development phases.

• Coordinate activities with external suppliers and consultants.

• Select, develop, and evaluate personnel effectively.

• Oversee multiple strategic programs and initiatives across the organization.

• Define program portfolio objectives, timelines, milestones, and budgets.

• Communicate strategic program proposals and critical outcomes to senior and executive leadership.

• Lead matrixed teams and vendors, influencing stakeholders across various functions.

⛳️ Requirements

• A Bachelor’s degree or an equivalent qualifying degree for degrees obtained outside the United States is required.

• At least 15 years of relevant experience with a minimum of 10 years in a managerial role, or an advanced degree with at least 13 years of relevant experience and 10 years of managerial experience.

• Advanced knowledge in management and leadership to guide cross-department project teams or manage across multiple functions.

• Mastery in a specific technical discipline or broad expertise across related disciplines.

• Unrestricted U.S. work authorization at the time of hire and throughout employment; this role does not offer sponsorship.

• For Bachelor’s degrees from outside the United States, a degree that meets the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is necessary.

• Preferred: Advanced degree (MS or PhD) in Engineering, Reliability Engineering, Statistics, Applied Mathematics, Data Science, Materials Science, or a related field.

• Preferred: Experience in high-reliability industries such as Medical Device, Aerospace, Defense, Semiconductor, Automotive, or Energy.

• Preferred: Proficiency in Shainin Red X, Fault Tree Analysis (FTA), Apollo RCA, Event & Causal Factor Analysis, Physics of Failure, Reliability-Centered investigations, and 6-Sigma.

• Preferred: Background in building or leading Reliability Engineering, Failure Analysis, Investigation Excellence, or Quality Intelligence organizations.

• Preferred: Expertise in Weibull analysis, reliability growth, accelerated life testing, and reliability modeling.

• Preferred: Knowledge in DOE, regression modeling, predictive analytics, Bayesian methods, and complex data interpretation.

• Preferred: Experience in implementing enterprise-wide technical training and certification programs.

• Preferred: Experience in developing communities of practice and technical career frameworks.

• Preferred: Formal certifications in Reliability Engineering, Six Sigma, Shainin Red X, Quality Engineering, Statistics, or related fields.

🏝️ Benefits

• Competitive salary and flexible Benefits Package.

• Health, Dental, and vision insurance.

• Health Savings Account.

• Healthcare Flexible Spending Account.

• Life insurance.

• Long-term disability leave.

• Dependent daycare spending account.

• Tuition assistance/reimbursement.

• Simple Steps (global well-being program).

• Incentive plans.

• 401(k) plan with employer contribution and matching.

• Short-term disability.

• Paid time off.

• Paid holidays.

• Employee Stock Purchase Plan.

• Employee Assistance Program.

• Non-qualified Retirement Plan Supplement.

• Capital Accumulation Plan.

• Temporary employees are entitled to paid sick time, as mandated by applicable state law.

• Reasonable accommodations for qualified individuals with disabilities.