About the position
As the Sr. Product Development Engineer, you will be the team/project leader who is responsible for the timely and quality execution and management of assigned design and development projects in order to meet the Company’s short term and long-term goals. You will be knowledgeable and vigilant with the IP protection of the Company’s ideas and products. Being a “hands on” development professional, you will be able to implement your excellent CAD knowledge and skills (Solidworks preferred) for the creation of parametric models that drive the creation of ASME Y14.5 compliant manufacturable prints.
Responsibilities
- Participate in and/or organize key customer interactions and communications in partnership with the sales and marketing team to document and develop design concepts.
- Develop design concepts through full production launch and maintenance in accordance with the Company design quality system.
- Be a productive member of cross-functional teams to assist in the creation of design documents for assigned projects, as required by applicable medical device standards and internal procedures.
- Work directly with cadavers and in surgical situations.
- Lead, participate in, and support product development activities including concept, planning, design and execution stages of major new products or product enhancements.
- Conduct risk assessment, prototyping, design for manufacturing, and design for inspection.
- Author testing protocols, conduct physical testing, and generate test reports.
- Oversee pilot production and design reviews.
- Conduct verification, validation, and pre-production activities.
Requirements
- Bachelor’s degree in Mechanical Engineering or equivalent engineering discipline.
- 5+ years of mechanical design and/or manufacturing experience.
- 3+ years of experience bringing products through the development cycle in a regulated industry, preferably in orthopedic medical device development.
- Familiarity with MS Office software including Word, Excel, PowerPoint, and Project.
