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Sr. Product Development Engineer
2 months ago
Job Description
The Senior Product Development Engineer is responsible for designing and developing new products within a team environment and for providing sustaining engineering support for existing products in support of the company's innovative electrosurgical device program.
Roles & Responsibilities
- Translate customer and business needs into engineering specifications throughout the product design and development process.
- Develop detailed mechanical product designs and manufacturing fixtures through document control systems.
- Manage vendor supply chain sourcing including outsourcing of complex assemblies.
- Develop and execute test methods, protocols and reports to evaluate product acceptance criteria and document results.
- Participate in and/or lead design review meetings.
- Evaluate process and design alternatives based on Design for Manufacturability principles.
- Provide technical leadership to ensure project deliverables are met in a timely manner.
- Develop project timelines and schedules based on cross-functional team input.
- Manage project timelines and budgets. Experience with MS Project is preferred.
- Develop and execute process validation activities based on best practices
- Evaluate and implement design changes for existing products (sustaining engineering).
- Manage or mentor junior engineers.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
Qualification and Core Competencies
- Bachelor's Degree in engineering related field or equivalent.
- Minimum 7 years in design/engineering for medical device development and/or manufacturing.
Skills and Experience
- Experience with full life-cycle engineering, from concept (prototyping) to production transfer, for FDA-regulated Class II/III medical devices following design controls best practices.
- Expertise in component and assembly design using SOLIDWORKS.
- In-depth knowledge of commonly used manufacturing processes, construction, and assembly techniques, especially in the context of catheters and guidewires such as extrusion, molding, grinding, welding etc..
- Experience in material selection for medical devices especially for catheters and guidewires
- Experience in building and maintaining supplier relationships for sourcing key components and assemblies.
- Prior experience designing and developing catheters and/or guidewires in medium to high volumes
- Familiarity working in a dynamic office environment including laboratory, production areas, and controlled environment rooms.
