Staff Engineering Project Manager - Oxinium Hip VS

Job Summary:

Responsible for ensuring successful completion of engineering projects through multi-functional coordination of technical engineers in conjunction with the Manufacturing Engineering Director. Requires conceptual and practical expertise managing the development, implementation, and evaluation of designs. Supports production process design and testing to ensure completion of projects as efficiently and effectively as possible.

Provides recommendations to strategic decisions that affect the functional area of responsibility, supports the development of schedules for manufacturing transfer of legacy product, deliver on landmarks to ensure that the project is delivered on time and on budget. Provides the voice of the factory during manufacturing transfer or product sustaining meetings. Drives factory level execution.

Requires specialized depth in project scheduling and reporting tools inclusive of risk registers. Create project plans for large projects requiring significant multi-functional team effort. Maintains and audits project documents, project plans, weekly reporting of project status, communication plans, risk registers, resource plans, etc. Assists through the preparation of various presentations, workshop preparation, and project updates. Leads projects with global scope and routinely reports to Executive Staff regarding status.

Works independently on situations which require application of project/improvement methods across a range of programs/projects/areas to build the capability of others. Swiftly visualizes processes, problems and opportunities and uses both graphical and statistical analysis to deliver improvements.

Develops, improves, and maintains all manufacturing documentation per compliance in assigned areas under limited supervision; documenting manufacturing processes through validation, ensuring production and distribution of Orthopedic Medical Devices are compliant to regulatory authorities' regulations which include ISO13485 Medical Devices, FDA 21CFR 820 & EU/MDR guided by functional policies. Trains and develops junior and senior level engineers in manufacturing documentation compliance. Approve procedures as appropriate.

Develop effective work relationships with business leaders, simultaneously linking key projects while identifying and engaging with domain experts and key stakeholders.

Communicates difficult concepts and negotiates with others to create a collaborative work environment. Explains in-depth information to others in straightforward/non-contentious situations. The role impacts quality of own work and the work of others on the team, requiring judgements and collaboration to identify innovative solutions.

Responsibilities:

• Responsible for leading multi-functional projects and change programs for the Engineering Department, relevant to the overall project of building, equipping, staffing, validating, and delivering on a world-class manufacturing facility. As Engineering coordinator, ensure each engineering project team is reaching their work and managing project governance. Ensures measurable success, by reporting project management metrics and targets, including but not limited to timelines, resourcing, budget, etc. Implements best-practice project management practices, applying takeaways and continuous improvement principles as needed to ensure the highest quality of operations. Ensures all project issues and risks are clearly communicated and raised as appropriate
• Develop/Improve methods for manufacturing components and assemblies in line with leadership expectations, focusing on Oxinium product transfer from Memphis to SNOM.
• Create/Update work instructions and routers with efficient flow. Design, develop, construct, update, and implement tools, fixtures, and gauges. Release instructions, drawings, PM and calibration requirements and spare parts' list. Consistently lead multiple Process Validation activities, including all aspects of IQ/OQ/PQ.
• Write protocols for processes, provide guidance and review protocols developed by junior engineers prior to submission and execution. Assist in the writing of protocols to provide SME guidance as needed. Collect data and apply Minitab to run a capability analysis. Understand Cp, Cpk, normal distribution and ability to determine study sample sizes through hypothesis testing. Support the writing process characterization/engineering study protocols. Determine if data is statistically valid and write reports.
• Lead investigations, provide engineering inputs to appropriately disposition material. Train and develop junior engineers in CAPAs, complaints analysis and MRB. Conduct investigations, identify, and implement corrective and preventative actions, support the appropriate disposition of material by providing technical expertise and guidance with the Quality group.
• Lead multiple multi-functional teams on projects with significant business impact, works independently with minimal guidance. Analyzes technical manufacturing problems of high complexity in the manufacture or purchase of raw material through finished goods and provides solutions/recommendations to maintain efficient flow of product and leads implementation improvements
• Develop proposed Risk Assessments for assigned projects under general supervision. Align with all HSE training requirements and procedures. Identify and lead actions for HSE improvements with guidance from leaders as needed.

Education:

• BS in Engineering, Science, or related field

Licenses/ Certifications:

• L4 Improvement Practitioner (Greenbelt) training towards L5 Improvement specialist (Black Belt) advantageous.

Experience:

• 5+ years engineering experience in Medical Devices CNC machining environment & extensive knowledge of cleaning system for medical devices as per ISO 19227-2018
• 2+ years of experience in Project Management including planning, organizing, monitoring, and helping lead sophisticated projects.
• 2+ years leading projects in a manufacturing operation with experience working in a machining environment a plus.
• Expertise in advanced Lean/Six Sigma, Project and tools to enable identification and delivery of improvement opportunities aligned to key business goals.
• Track record of leading projects, using appropriate processes and tools, delivering desired results.
• Experience working with all levels of the organization and possess platform skills, presence, and confidence.
• Substantial and demonstrated applicable hands on engineering and Lean experience

Competences:

• Resolves problems by identifying and selecting solutions and applying technical experience and precedents with a hands-on approach, previous working experiences with CNC environments is required. Lead projects with limited supervision. Able to perform Root Cause Analysis, VSM, DFM analysis and complete Design Transfer/Risk Management work. Basic understanding of VAVE, MSA, Lean manufacturing principles, and 6 Sigma
• Leading teams with in-depth knowledge of handling personality types, identifying team development stages, use of motivational techniques, understanding of learning styles and knowledge of situational leadership with an understanding of leadership styles to suit the working environment
• Project planning, financial planning, cost benefit analysis and risk management. Ability to present and communicate successfully at leadership meetings which require an excellent presentation, verbal, and written communication skills.
• Knowledge of coaching and motivational models including GROW, Maslow's Hierarchy, Hertzberg's Motivational Two Factor Theory, etc.
• Commercial environment for business and economic risk, including legislation changes, government regulations or trading conditions which can impact Project selection and implementation.
• Knowledge of resource management, allocation, and project management tools such as MS Project, PlanView, and Excel.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform this job. Reasonable accommodation may be made to enable individuals with disabilities.

• Regularly required to sit and use hands to handle or feel objects, tools, or controls.
• Occasionally lift and/or move 25 pounds.
• Frequently reach with hands and arms.

Travel Requirements:

• Between 25% - 50% on location in Penang, Malaysia as required to support the technical transfer, validation, and critical process implementations. This may include weeks or months at a time, often considered a "commuter assignment". Travel is subject to the approval of visa, permits and any tests or vaccinations to align with Malaysian immigration. Any costs incurred securing work or residency permits will be covered by the company and meeting the travel requirements is a prerequisite for the position.

About Us:

Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living! We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential!

Care, Collaboration, & Courage:

Care means that we show empathy and understanding for each other, our customers, and patients.

Collaboration means we work together as a team, based on mutual trust and respect.

Courage is about continuous learning, innovation, and accountability.

Veterans are strongly encouraged to apply.

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.