Project Engineer

Project Engineer The Project Engineer will lead Product Realization and Revalidation projects under

ISO13485

Quality Systems through the project life cycle with continued day-to-day management of the project and team. The Project Engineer is responsible for ensuring that projects remain on track, technically correct and under budget. The Project Engineer will support commercial operations and manufacturing to close new business and provide technical support to improve operational quality and effectiveness of existing products.

Essential Duties and Responsibilities:

Utilize Stage Gate Management Process to organize, plan and deliver high quality, fully integrated end-to-end solutions that meet customer expectations and deliver promised results encompassing the following elements: Provides guidance and direction to project team members, contractors, service providers, for day-to-day project related activities with an onsite presence. Drives successful implementation and management of assigned projects through project's entire lifecycle including operational readiness of the organization, customer communications, etc. Manages costs to stay within budget constraints with responsibility for cost estimation, budgeting, forecasting and management of contingency and allowances, cash flow projections etc. Manages project schedule, defines project plan & execution strategies, and provides tactical coordination of project activities. Acts as a liaison between external parties supporting the project and internal departments and team members. Leads scope development, finalization, stakeholder alignment and scope change management. Plans, organizes and oversees the attainment of project performance goals, objectives, priorities and standards. Hosts regular project meetings to ensure team members are tracking to timely completion of assigned tasks and key issues, risks, and roadblocks are identified. Identifies key decisions that need to be made, develops recommendations, and aligns stakeholders on the ultimate decision. Ensures the completeness and quality of work packages and project deliverables. Coordinate with Procurement to manage vendor relationships relevant to project throughout the life cycle, including procurement processes, contract negotiations, and vendor/ contractor performance management. Proactively identifies, manages and reports to all relevant parties including upper management, any risks to cost, schedule, scope or intended use of the project or its business case. Ensures regular communications regarding project updates to involved parties on project goals, objectives, priorities, plans, financials, schedules, issues, risks and metrics. Ensures operation in accordance with company policies and procedures, local regulations, FDA regulations and ISO standards Designs and maintains project and technical documentation. Develops engineering solutions to technical problems. Extensive inter-department interaction with sales, marketing, operations, engineering, and customers, as well as being directly responsible for critical interface regarding in-house projects and custom proprietary projects. Supports quoting of new business including tooling and part pricing. Builds integrity and credibility at all levels.

Supervisory Responsibilities:

No direct reports Lead cross functional teams to effectively execute assigned projects.

Responsibilities:

Other Duties Other responsibilities, as necessary.

Expertise:

Qualifications - Experience/Training/Education/Etc.

Required:

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Plastics Engineering, or a related field. Minimum of 3 years project management experience leading engineering projects in

ISO-13485/ ISO-9001

certified manufacturing plants. Minimum of 2 years Medical product experience. Proven ability to influence, plan, manage and coordinate team to deliver on expectations of diverse set of clients such as Manufacturing, Commercial, Product Development, Quality & Regulatory and Supply Chain.

Preferred:

Experience in molded plastic part design and understanding of mold and tooling design. Project Management Professional (PMP) Certification. Experience with ERP systems such as DELMIAWorks (formally IQMS), Oracle, SAP or Microsoft Dynamics. Experience with Continuous Improvement and Quality Management techniques such as Six Sigma, Lean, TQM, DMAIC, etc.

Expertise:

Knowledge & Skill Requirements Ability to translate customer business needs into appropriate project scope; Implications of technical choices on scope, cost, schedule, standards used, business risks, regulatory compliance etc. Expertise in the process of project management; understands and champions role of engineering and need to maintain active participation; value of milestones and deliverables; Need of actively managing cost, schedule and scope; Change Management, Value Engineering etc. Experience in Start-up, Commissioning, Verification, Qualification, Validation. Experienced in Product Realization under

ISO13485

Quality Systems for medical devices. Understands fundamental design principles, regulatory requirements and acceptable practices for commissioning, qualification and validation of facility, equipment and systems in cGMP environments. Ability to coordinate with various resources and keep all parties on task, on time, and on budget. Ability to communicate clearly, both written and verbal, at all levels, both internally and externally. Customer facing. Ability to effectively lead cross-functional, cross-cultural, geographically dispersed teams to meet business objectives. Ability to support his/her own position on technical, business or organizational issues with logical reasoning, and ability influence others to support position. Ability to engage people with different opinions, thoughts and convictions on work-critical technical or business issues and to build alignment to move business forward. Good technical writing skills.

Additional Requirements:

Business travel up to 10% may be required. Valid driver's license, passport.