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 oversee a centralized Investigation Excellence Engineering function.

• Formulate the organizational strategy for Root Cause Analysis and advanced quality analytics.

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

• Manage escalation support for critical investigations, significant quality events, recalls, and CAPAs.

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

• Develop and mentor technical experts in investigation disciplines.

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

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

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

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

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

• Oversee the investigation and evaluation of existing technologies.

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

• Direct the development of new concepts from initial design to market launch.

• Manage design feasibility studies.

• Monitor documentation throughout the research and development process.

• Coordinate activities with external suppliers and consultants.

• Select, develop, and evaluate personnel.

• Manage multiple strategic programs and initiatives across the organization.

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

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

• Lead matrixed teams and vendors across various functions.

⛳️ Requirements

• Bachelor's degree or an equivalent qualifying foreign degree.

• At least 15 years of relevant experience, including 10+ years in a managerial role.

• OR an advanced degree with a minimum of 13 years of relevant experience and 10+ years of managerial experience.

• Advanced knowledge in management and leadership.

• Mastery in a specific technical area or extensive expertise across multiple related disciplines.

• Unrestricted U.S. work authorization at the time of hire and for the duration of employment; U.S. sponsorship is only available for Principal-level roles and higher.

• Preferred: advanced degree in Engineering, Reliability Engineering, Statistics, Applied Mathematics, Data Science, Materials Science, or a related field.

• Preferred: experience in medical device, aerospace, defense, semiconductor, automotive, energy, or other high-reliability industries.

• Preferred: expertise in Shainin Red X, Fault Tree Analysis, Apollo RCA, Event & Causal Factor Analysis, Physics of Failure, reliability-centered investigations, and Six Sigma.

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

• Preferred: experience in deploying 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 insurance.

• Dental insurance.

• 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 match.

• Short-term disability.

• Paid time off.

• Paid holidays.

• Employee Stock Purchase Plan.

• Employee Assistance Program.

• Non-qualified Retirement Plan Supplement.

• Capital Accumulation Plan for Vice Presidents and above, or subject to IRS earning minimums.

• Paid sick time for temporary employees as required by applicable state law.