Project Manager, Operational Technology

Job Summary:

Smith+Nephew is looking for a Project Manager to join our Operational Technology (OT) team. This position is responsible for prioritizing and coordinating various OT projects worldwide as part of Smith+Nephew's Digital Transformation activities.

The Project Manager is responsible for working with project leaders within Operational Technology and with their associated multidisciplinary project teams to ensure that project timelines, budgets, and landmarks are realistic, reported, and achieved. The Project Manager will create and update project reports to the Vice President, Operational Technology, and for review by executive management. They will follow up on completed projects to report on KPI achievement.

Responsibilities:

• Develop concrete, detailed plans for technical projects, including schedule, budget, team roster and duties, project goals, and timelines
• Hold and run meetings to create and update project plans for presentation to senior management
• Work with project leaders to identify potential roadblocks or issues and develop mitigation plans
• Monitor projects to ensure they remain on track, meet timelines, stay under budget, and develop according to the plan, highlighting issues and managing solutions supported by RAID (Risk, Action, Issues, Dependencies log)
• Capture and detail all project related documentation and outcomes through governance to include reporting or presenting to appropriate stakeholders.
• Develop metrics and processes to constantly improve projects efficiency and quality
• Provides other duties as required

Minimum Requirements:

• Bachelors Degree in a Technical Discipline
• 3-5 years' experience in leading various projects or programs, including demonstrated success with change management projects influencing cultural change
• Strong knowledge of and practical application of project management methodology
• Certification in PMI/PMP/Agile
• Specific experience in Medical Device manufacturing or product development
• Excellent communication skills and attention to detail
• Strong planning, organizational, critical thinking and problem-solving skills
• Ability to interface and influence at multiple organizational levels
• Ability to manage multiple projects and tasks within tight timelines
• Customer first approach to anticipate and deliver customer needs and expectations

Nice to Have:

• Ability to analyze and resolve operational and process issues through liaison with stakeholders
• Ability to propose solutions within the context of the business by applying technical knowledge to evaluate the associated risks and implications
• Ability to identify technical and/or operational problems and resolves by implementing innovative, customer focused solutions
• Experience in development of product requirements into machine User Requirements Specifications (URS) that mitigate patient risk through pFMEA traceable URS risk mitigations
• Working knowledge of key Medical standards such as FDA 21 CFR Part 11, FDA CFR Part 820, ISO 14971, ISO 13485, ISO 9001, CMDCAS/CMDR. Understand medical device requirements for software validation, Installation Qualification (IQ), Operation Qualification (OQ) and Process Qualification (PQ) as it relates to production equipment validation.
• Experience in either direct role in the medical device/biopharma sector or consulting work on a medical device/biopharma project

Physical Demands:

• Regularly required to be independently mobile.
• Interact with a computer and communicate with peers and co-workers.
• Able to lift 25 pounds.

Travel Requirements:

• 10-25%

Comments:

This job description is an outline of the major recurring responsibilities of the job and is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives and special assignments.

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.

We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities.

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.