New Product and Sustained Product Engineering with high technical responsibility. Take technical lead to define, design, build, and testing novel medical equipment from concept through to manufacturing. Will be responsible for supporting large design projects and rapid prototyping in a small team environment. Will work with an engineering manager to provide technical guidance and direction with expectations to deliver quality work in a timely manner.
Duties and Responsibilities include the following. Other responsibilities may be assigned:
• Work with an Engineering Manager to support management of both product development and manufacturing operations
• Provide technical leadership and guidance on engineering projects; make technical direction assessments, assist junior engineers, provide mentorship
• Work with manufacturing partners and supply partners to integrate components into a system, transfer designs to manufacturing, and support manufacturing operations. Work with contract manufacturers to ensure good quality practices and to drive down costs
• Be responsible for technical decision making to move a project forward while balancing business interests, technical feasibility, and quality.
• Make detailed 3D CAD models of assemblies and components of device
• Search out materials, components and systems for the product
• Build and troubleshoot prototypes of project components and full builds
• Support, redesign, and optimize products already on the market based on customer and manufacturing needs
• Lead documentation efforts with project team to maintain design and development documentation, including but not limited to CAD drawings, schematics, the project Masterfile, and design outputs.
• Lead documentation efforts related to regulatory submissions by working with the project team and RA/QA teams at Genetesis
• Work adaptively in a fast-paced small team environment with aggressive deadlines
• Travel to offsite locations as required
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Must have at least 10 years of experience in mechanical engineering or product design
• Design experience on mechanical systems and optimization for manufacturing operations
• Professional in 3D CAD modeling using Solidworks or similar program
• 5+ years experience in medical device or related industry
• Preferred Basic Shop Skills: Milling, Lathing, CNC machining, Wood Shop
• Be familiar with medical device design standards and best practices (ISO, IEC, CFR)