Mechanical Engineer III (Direct Hire)
Job Requisition: 7069
Description for Mechanical Engineer III:
As a Mechanical Engineer III you will lead team collaboration with peer engineering teams, manufacturing, suppliers, and customers to drive product designs across all phases of the product life cycle. Your efforts will generate best in class, unique and innovative product offerings and/or solutions while assuring technical quality excellence, and timely completion of project timelines. You will use your expertise to aid the mechanical engineering team’s development, planning and growth.
Responsibilities for Mechanical Engineer III:
- Work with internal and external customers to influence, design, develop, and launch new products and/or product or process solutions that satisfy requirements for manufacturability, service, installation, customer, and applicable international standards/regulations.
- Collaborate with suppliers during design and development to understand and establish requirements that align with supplier processes capabilities.
- Initiate, lead, and/or contribute to problem solving and continuous improvement initiatives for new development projects and sustaining efforts for mature products.
- Provides leadership, technical direction and support to engineering team to promptly identify, define and resolve engineering, design and development issues to meet multiple project needs and objectives.
- Develop product requirements based on customer needs, various design inputs, and generally accepted state-of-the-art clinical data, applicable international standards and regulations, and customer feedback.
- Establish, communicate, and optimize development timelines to accelerate project schedules.
- Lead and participate in design reviews, design/usability FMEA efforts, risk mitigation/risk management, and defect resolution while adhering to established timelines.
- Design and development of products in compliance with the company’s Quality Management System, design, safety, regulatory and customer requirements.
- Lead and collaborate with internal departments, customers and/or suppliers related to pre- and post-market investigations, corrections, corrective actions, and improvements.
- Adhere to Quality Management System requirements applicable to work performed, including but not limited to, Good Documentation Practices, Document Control, Record Control.
- Perform duties in a safe manner, following all safety policies and procedures, to prevent injury to self or others.
Requirements for Mechanical Engineer III:
- Bachelor’s degree in Mechanical Engineering, or Biomedical Engineering with mechanical focus.
- 8+ years’ experience working in the medical device industry, or other regulated industry.
- Experience as a technical leader owning product designs from concept through design transfer, and post-market product sustaining efforts.
- Possess a strong understanding of systems engineering, engineering concepts and manufacturing processes, as well as the ability to apply to issues and identify novel solutions.
- Extensive experience using solid modeling CAD software for solid models, surface modeling, assembly management and engineering drawing creation; SolidWorks/ SolidWorks PDM experience preferred.
- Ability to balance competing technical, cost, and timing demands.
- Ability to communicate complex systems or concepts in a way that is understandable to non-technical individuals.
- Ability to work collaboratively and lead collaborative efforts in a multidisciplinary setting.
- Conceive new ideas and approaches not readily apparent or previously tried that enhance the organization's systems or products.
- Utilize a systematic approach to problem solving and issue resolution combined with a good understanding of the relevant technologies and their practical applications.
- Must exhibit a high level of initiative, as well as demonstrate the ability to work independently and to develop technical solutions to complex problems that require ingenuity and creativity.
- Ability to apply fundamental engineering concepts through computation and analysis, analyze and synthesize information in order to examine assumptions.
- Ability to adapt approach/method to meet organizational needs, customer, applicable regulatory requirements, and/or based on new information.
- Experience in designing to international product standards including, but not limited to: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, ISO 14971, ISO 15223-1.