Sr Reliability Engineer - Exempt

Must Have:
Ability to analyze data, create and track key performance indicators (KPIs), and make data-driven decisions to enhance process effectiveness
Adept at creating detailed reports, presentations, and summaries tailored to various audiences, from technical teams to senior leadership.
Excellent verbal and written communication abilities to clearly convey complex technical information to both technical and non-technical stakeholders.
Experience in leading change management initiatives within an organization.
Experience using statistical techniques to assess process performance and guide corrective actions based on quantitative insights.
Experience with process management software or tools (e.g., JIRA) and strong proficiency in Microsoft Office Suite.
• Previous *** experience • Good understanding of lean principles and project management methods and techniques. • Demonstrated problem solving and analytical skills. • Demonstrated success improving, optimizing, standardizing, and streamlining customer support processes that yielded improvements in customer satisfaction. • Ability to make sound and quick decisions. • Good understanding of the impact of change, the interdependencies and impact on the business and IT projects. • Excellent interpersonal skills including the ability to influence and build relationships across the organization. • Strong organizational skills with excellent attention to detail. • Familiarity with ServiceNow (or similar ITSM solution) and its capabilities.
Proficiency in statistical analysis methods and tools to monitor trends, identify patterns, and predict emerging issues.
Proven track record of collaborating across multiple teams, including engineering, quality, and operations, to align on goals and drive resolution of issues.
Strong interpersonal skills to facilitate meetings, discussions, and presentations, ensuring that key updates, data insights, and progress reports are effectively communicated.
Strong knowledge of data presentation methods, including dashboards, heatmaps, and graphs
Strong problem-solving skills with the ability to identify root causes and implement corrective actions.
Strong understanding of regulatory standards and compliance requirements relevant to the industry (e.g., ISO, FDA, CAPA).
Nice to Have:
4. Experience with medical devices sterilization methods (i.e., ethylene oxide, radiation, etc.) 5. Experience implementing appropriate risk mitigation actions with knowledge of packaging or process and process Risk Management as per FDA & ISO standards. 6. Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools. 7. Working knowledge of SolidWorks or other packaging CAD programs (i.e., TOPS, SolidWorks, CREO, etc.). 8. Experience with Minitab or other statistical software.
Familiarity with the medical device, robotics, or high-tech manufacturing industries.
Project management certification (e.g., PMP) or experience leading projects from initiation to completion.
JOB DESCRIPTION
**HM will also consider more experienced candidates as well
The Reliability Engineer will assume the role of Process Manager and be responsible for overseeing and optimizing the Issues Triage and Investigation (ITI) processes, which directs our issues handling and failure investigation workflows. This role will focus on improving process efficiency, enhancing communication between cross-functional teams, and ensuring that the process effectively facilitate the resolution of issues. The Process Manager will work closely with teams such as Fleet Management, Quality, Operations, Reliability Testing and Field Service to drive continuous improvements.
Key Responsibilities:
Process Development & Optimization: Design, implement, and continually refine the ITI processes and cross-functional communication. Identify bottlenecks, inefficiencies, and areas for improvement
Issue Monitoring & Analysis: Monitor reported issues across various sources. Categorize issues, identify trends, and analyze underlying causes to proactively address emerging problems
Stakeholder Collaboration: Act as a central point of contact for teams across the organization, ensuring that process updates are communicated effectively, and all stakeholders are aligned
Performance Monitoring: Regularly track and analyze process performance metrics (e.g., throughput, resolution times, error rates) to measure the effectiveness of current processes and identify opportunities for enhancement
Compliance & Risk Management: Ensure all processes are compliant with FDA regulations, quality standards, and internal policies
Training & Support: Provide training and support to team members on process improvements and best practices. Ensure that all staff understand their roles within the process and the importance of adhering to standards
Cross-Functional Leadership: Lead and facilitate cross-functional meetings to address process improvements, drive initiatives, and foster collaboration among teams such as R&D, Manufacturing, Quality, and Field Service
Documentation & Reporting: Develop, maintain, and update process documentation to ensure clarity and consistency. Provide regular reports to senior management on process performance, key metrics, and any necessary adjustments
Trending & Predictive Analysis: Utilize data from reported issues to establish trends, predict potential systematic problems, and work with teams to implement preventive measures
Top 3 technical skills that are required for the role:
Proficiency in statistical analysis methods and tools to monitor trends, identify patterns, and predict emerging issues
Ability to analyze data, create and track key performance indicators (KPIs), and make data-driven decisions to enhance process effectiveness
Experience using statistical techniques to assess process performance and guide corrective actions based on quantitative insights.
Education Required:
Bachelor Degree/Master Degree in Biomedical Engineering, Computer Science, Electrical or Software Engineering
Years' Experience Required:
Senior - Bachelor Degree (4 yrs), Master Degree (2 yrs)
Principal - Bachelor Degree (7 yrs), Master Degree (5 yrs)
Will the contractor be working 40 hours a week? If not, weekly estimate?
Yes
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like?
Hybrid, minimum 3 days onsite
What is your timeline for scheduling interviews?
2 weeks,
What product line will this person support?
Hugo
The Reliability Engineer will be responsible for overseeing and optimizing the Issues Triage and Investigation (ITI) processes, which directs our issues handling and failure investigation workflows. This role will focus on improving process efficiency, enhancing communication between cross-functional teams, and ensuring that the process effectively facilitate the resolution of issues. The Process Manager will work closely with teams such as Fleet Management, Quality, Operations, Reliability Testing and Field Service to drive continuous improvements.
Responsibilities may include the following and other duties may be assigned. Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. Completes risk analysis studies of new design and processes. Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. Ensures that corrective measures meet acceptable reliability standards. Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives. May develop mathematical models to identify units, batches or processes posing excessive failure risks. As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.