- Responsible for participating in and/or organizing key customer interactions and communications in partnership with the sales and marketing team to document and develop design concepts and develop them through full production launch and maintenance in accordance with the Company design quality system
- Willingness to 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 the following product development activities:
- Concept, planning, design and execution stages of major new products or product enhancements
- Risk assessment, Prototyping, Design for Mfg. and Design for Inspection
- Testing (Protocol authorship, Physical Testing, and Test Report generation)
- Pilot Production
- Design reviews
- Verification, Validation, Pre-production
- Bachelor's degree in Mechanical Engineering or equivalent engineering discipline with 5+ years of mechanical design and /or manufacturing experience, of which 3+ years of bringing product through the development cycle in a regulated industry is required (Preference is given to orthopedic medical device development).
- Familiarity with MS Office computer software including Word, Excel, PowerPoint, and Project
- This position is required to travel up to 30% of the time for trade shows, labs, surgeon training events, and other events as scheduled.
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Senior Product Development Engineer - Ponte Vedra Beach, United States - Treace
Description
Job Description
Job DescriptionCompany DescriptionTreace's mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers' expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.
Job DescriptionAs 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.
What you will be responsible for:
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