Project Engineer

Comar•Woodville, WI

4d•Onsite

About The Position

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. This role is responsible for ensuring that projects remain on track, technically correct, and under budget. The Project Engineer will also support commercial operations and manufacturing to close new business and provide technical support to improve operational quality and effectiveness of existing products. This involves utilizing a 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.

Requirements

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
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
Understand 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
Business travel up to 10% may be required
Valid driver’s license, passport

Nice To Haves

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.

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
Provide guidance and direction to project team members, contractors, service providers, for day-to-day project related activities with an onsite presence
Drive successful implementation and management of assigned projects through project’s entire lifecycle including operational readiness of the organization, customer communications, etc.
Manage costs to stay within budget constraints with responsibility for cost estimation, budgeting, forecasting and management of contingency and allowances, cash flow projections etc.
Manage project schedule, define project plan & execution strategies, and provide tactical coordination of project activities
Act as a liaison between external parties supporting the project and internal departments and team members
Lead scope development, finalization, stakeholder alignment and scope change management
Plan, organize and oversee the attainment of project performance goals, objectives, priorities and standards
Host regular project meetings to ensure team members are tracking to timely completion of assigned tasks and key issues, risks, and roadblocks are identified
Identify key decisions that need to be made, develop recommendations, and align stakeholders on the ultimate decision
Ensure 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 identify, manage and report to all relevant parties including upper management, any risks to cost, schedule, scope or intended use of the project or its business case
Ensure regular communications regarding project updates to involved parties on project goals, objectives, priorities, plans, financials, schedules, issues, risks and metrics
Ensure operation in accordance with company policies and procedures, local regulations, FDA regulations and ISO standards
Design and maintain project and technical documentation
Develop 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
Support quoting of new business including tooling and part pricing
Build integrity and credibility at all levels
Lead cross functional teams to effectively execute assigned projects
Other responsibilities, as necessary