Project Engineer- Sustaining, Ligation (18 Month Contract Role)

Position Summary

The Project Engineering position will be responsible for all aspects of product sustainability for the Ligation portfolio from design control related design changes to investigations and root cause analysis and working with the supplier on any design related changes or improvements.   This engineer will serve in a technical role with key responsibilities of project management inclusive of collaboration and leadership with key internal and external stakeholders.  A successful candidate will understand and be knowledgeable in key aspects of project management, design control, supply chain, manufacturing, and inspection requirements as these relate to Product Sustainability.

We are looking for someone who is:  

•    A motivated self-starter with effective interpersonal and leadership skills
•    An organized and detailed orientated individual who is adept at problem solving 
•    Committed to collaboration and teamwork with internal and external stakeholders 
•    Able to balance competing interests and lead to resolution with mutual commitment 
 

Principal Responsibilities

•    As an integral part of the project team and or leader of a project team, provides design, manufacturing, supply, component, timing, and assembly expertise to projects.
•    Work closely with SME’s to define sample/product acquisition required for aging, packaging, ship test, sterilization, customer labs, samples etc. 
•    Managing project related communications, upward and downward through the organization; escalating key issues and presenting options for resolution to the Senior Leadership Team
•    Responsible for managing / communicating validation schedules including IQ/OQ/PQ, product production within agreed upon scope, budget, timeline, and quality with external partners. 
•    Interface with suppliers and manufacturing when implementing new processes.
•    Ensure all supporting documentation is drafted, approved, and documented with SAP and Agile. 
•    Support and lead efforts to generate, review and approve design control documentation.
•    Develop test plans, protocols, and reports. Analyze and present results, applying engineering analysis as necessary.
•    Proactively identify issues, achieve resolution, and resolve problems of highly significant complexity on designing parts, components, and subsystems
•    Drives quality improvements by risk assessment/mitigation eliminating sources of defects in the design, new product introduction and manufacturing processes. 
•    Remain current with all internal and appropriate external developments and policies in related areas of activity.

•    Establish SOP(s) where appropriate and initiate training, adherence to:
•    TMV(s) (Test Method Validation)
•    Real Time Aging retention, testing
•    V&V testing including IQ/OQ/PQ and PPQ Documentation, lab notebooks.
•    Support Engineering Evaluation of returned product when required.
•    Support Design and Development plans and Change Orders, technical reviews, and implementation. 
•    Provide other department support as requested by immediate supervisor.
 

Education / Experience Requirements

•    Prefer Bachelor level degree in Engineering / Technology or equivalent experience in medical device operation, planning and new product introduction
•    At least 3 years minimum engineering experience within a medical device environment
•    Experience working with manufacturing suppliers preferred
•    Excellent communication, presentation and multi-functional departmental leadership
•    A comprehensive understanding of ISO, GMP and FDA regulations
•    Experience in the commercialization of medical devices in U.S., globally is preferred.
 

Specialized Skills / Other Requirements

•    Strong analytical and problem-solving skills and comprehensive understanding of design control processes and validation of processes and designs.
•    Effective verbal, presentation and written communication skills.
•    Excellent interpersonal skills with demonstrated leadership, organizational influence and decision making competencies.
•    Proficient in Microsoft Office, and MS project.
•    Adept at CAD, ideally Solidworks
•    Working knowledge of medical device development, sterilization requirements and techniques, medical device regulations, and implantable medical device design requirements
•    Large company experience working with mulitple departments and locations
•    Willingness to travel out of country as required
#LI-DR1