Position #1521: Project Engineer
- Posted: 06/08/2017
- Closes: 08/31/2017
- Our client is a manufacturer and supplier of surgical instrumentation, sterilization case and tray systems to the medical industry and healthcare facilities worldwide.
Our client is seeking a qualified candidate as one of the key members of Case and Tray Engineering. They will, with general supervision from the Project/Program Manager, own and lead projects from solicitation and proposal through design transfer for medical device components.
They will lead the design and development of complex new products. This includes, but is not limited to:
• Manages all aspects of the project as required. (timelines, prototypes, testing, suppliers)
• Leads cross-functional project teams to support design and development.
• Understands all assigned project tasks and schedules and communicates status regularly.
• May work on multiple projects simultaneously.
• Drives problem solving of design related issues.
• Communicates and works with manufacturing to ensure design manufacturability.
• Meets with and works closely with the engineering team and customer to ensure all requirements are defined and met.
• Researches, specifies and makes recommendations for materials and/or alternative solutions that meet project requirements.
• Specifies and coordinates all prototype requirements and applicable testing through appropriate sources, either internal or external.
• Generates appropriate documentation as required per Paragon Design Control Procedures.
• Supports all departmental goals and objectives, and understands and follows corporate policies and procedures.
• Insures compliance with ISO, FDA and other applicable regulations.
• Remains up-to-date on market requirements & trends and suggest creative ways to improve designs both from cost and functional perspectives.
• Travel for but not limited to: training, departmental planning session, customer support.
• Under limited supervision, conceptualizes, designs and develops complex new products.
• Special projects as assigned.
• May support other functional areas within corporation.
• May provide supervisory assistance when assigned.
• May be responsible for performance management, including selection, training, employee development, performance reviews, cross training and disciplinary action.
• Once employee demonstrates competency in position, he/she may be required to train others in similar roles.
Successful candidates MUST HAVE these capabilities to be considered for this position:
• Bachelors degree in Engineering is required (Mechanical Engineering or Biomedical Engineering is preferred).
• Three (3) years, or more, of experience in product development within medical device, ideally in orthopaedics.
• Prior knowledge and experience in manufacturing processes of metals and plastics
• Project management skills (strategic/tactical planning and implementation capabilities) coupled with strong technical and technical skills.
• Ability to handle multiple priorities simultaneously.
• Knowledge of Design for Manufacturability (DFM) principles, biocompatibility requirements for material, ISO 13485, US QSR 21 CFR, and Part 820 Medical Devices, and basic understanding of human anatomy.
• Understanding of geometric dimensioning and tolerance (GD&T) requirements for application to design projects.
• 3D CAD modeling experience required (UniGraphics or SolidWorks preferred) along with Microsoft 2101 Suite or newer (particularly Excel).
- Location: Fort Wayne, IN
- Compensation: $70K - $86.5K
Qualified candidates please reference Position #1521
when submitting your resume to Search
or mail to: The Lake City Group.
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