Job Title
Lead Product Development Engineer.
----------------------------------- Job Description: We are seeking an experienced Lead Product Development Engineer to join our team. The successful candidate will lead the development of new medical devices and manufacturing processes, working closely with cross-functional teams to deliver high-quality solutions that meet user needs. Key responsibilities include leading technical assessments of new product design inputs, collaborating effectively with teams, and delivering original solutions to meet user needs.
Role Responsibilities:
• Support product development by leading technical assessments of new product design inputs, collaborating closely and effectively with cross-functional teams, delivering high quality, original solutions to meet user needs.
• Translate multiple inputs from regulatory, quality, marketing, human factors etc., into product requirements, specifications, and detailed trace matrices.
• Interface with marketing, healthcare professionals, customers, and suppliers as necessary to identify product opportunities, develop product solutions, solve problems, and complete projects leading up to commercialization of new and/or modifications to existing products.
• Provide appropriate direction or directly lead higher-level engineering efforts to design products, processes, equipment, tooling, and components using engineering principles on a Computer-Aided Design (CAD) system and evaluating them using analysis techniques such as Finite Element Analysis (FEA).
• Perform product testing, create models and prototypes to prove out new designs and changes to existing designs.
• Lead higher-level Engineering Development projects as assigned, including Problem-Solving projects to resolve issues in Manufacturing or Product Performance. Provide uniform solutions for international manufacturing operations.
• Champion Continuous Improvement of manufacturing processes and equipment through the use of Lean Manufacturing and statistical data analysis techniques such as Total Measurement Value (TMV), Gage Studies, Process Capability Studies, Design of Experiments (DOE), and Statistical Process Control (SPC).
• Lead or participate in project, design, and technical reviews.
• Interview, recommend, and assist in the selection of department personnel including engineers and summer interns.
• Troubleshoot and coordinate improvements to existing products, manufacturing processes, machine test equipment.
• Support regulatory submissions and clinical trials as required.
• Ensure projects are developed and documented in compliance with the Quality Management System.
• Develop, approve, and revise Quality System Documents, including SOPs, Work Instructions, and Validation Protocols & Reports.
• Adhere to and ensure the compliance of company policies, QMS procedures, and housekeeping standards.
Skills / Experience:
• Bachelor of Science in Mechanical or Biomedical Engineering, Professional Engineer certification, or advanced degree preferred; other technical disciplines considered.
• 6 or more years of relevant experience in the engineering field related to manufacturing.
• Strong analytical, technical, and problem-solving skills.
• Hands-on experience preferred.
• Effective verbal and written communication skills.
• Team player with good interpersonal skills.
• Proficient in Microsoft Office Suite, SolidWorks or equivalent modeling system, statistical analysis, and computerized analysis (FEA) applications.
Key Relationships / Interfaces:
• Self-motivated, high energy, positive attitude individual with the initiative and drive for timely completion of goals.
• Excellent multi-tasking, analytical, communication, and prioritization skills.
• Ability to work independently with minimal supervision as well as in a team environment.
• Excellent communicator with ability to run meetings and workshops.
• Able to travel domestically and internationally.
For further information please contact: [Contact Name] or call in confidence [phone number].