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Product Development Engineer (1 of 2)-7435131219
Description
DePuy Synthes Spine is currently recruiting for a Product Development Engineer located in Raynham, MA. DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world.
DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
DePuy Synthes Spine is the Spine business offering a comprehensive portfolio of spinal care solutions for the treatment of the most simple to the most complex spine disorders using traditional and minimally invasive techniques.
In the short term this position coordinates and conducts the review and remediation of Design History Files (DHFs) according to approved company policies and procedures. Work will involve addressing both active development projects as well as the DHFs of on-market products identified through the Global Remediation Quality Plan (GRQP). The Product Development Engineer will be responsible for conducting the review and remediation of Design History Files with the goal of revising and updating existing documentation to comply with company procedures. In the long term this position conducts design and product development activities associated with new spinal products and procedures.
The individual will be tasked with performing detailed and in-depth analysis’ of all aspects of design control documentation, including Functional and Design Requirements, Risk Analysis, Verification and Validation activities, Project Planning, and Design Change documentation practices. In addition to reviewing Design History Files, the candidate will also be responsible for conducting the remediation of all aspects of design control documentation to comply with company procedures. This work will include coordinating review and remediation activities within the GRQP team and along with external third party contractors.
Qualifications
A minimum of a Bachelor’s degree in Mechanical Engineering or another Engineering discipline is required. A minimum of 4+ years of product development or design control experience or equivalent is required. Experience with Class I and II medical devices is required. Experience in spine or orthopedic medical device industry is highly preferred. Experience in medical device design principles, material selection, ability to verify and validate design concepts, and understand design failure modes is required. Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T are required. Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc) is required. Experience with FDA Medical Device guidelines is required. The ability to effectively communicate with other team members is also required. This position may require up to 15% travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
Primary Location:North America-United States-Massachusetts-Raynham
Organization: DePuySynthes Products LLC (6149)
Job: R&D Engineering (R&D)
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Product Development Engineer (1 of 2)-7435131219
Description
DePuy Synthes Spine is currently recruiting for a Product Development Engineer located in Raynham, MA. DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world.
DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
DePuy Synthes Spine is the Spine business offering a comprehensive portfolio of spinal care solutions for the treatment of the most simple to the most complex spine disorders using traditional and minimally invasive techniques.
In the short term this position coordinates and conducts the review and remediation of Design History Files (DHFs) according to approved company policies and procedures. Work will involve addressing both active development projects as well as the DHFs of on-market products identified through the Global Remediation Quality Plan (GRQP). The Product Development Engineer will be responsible for conducting the review and remediation of Design History Files with the goal of revising and updating existing documentation to comply with company procedures. In the long term this position conducts design and product development activities associated with new spinal products and procedures.
The individual will be tasked with performing detailed and in-depth analysis’ of all aspects of design control documentation, including Functional and Design Requirements, Risk Analysis, Verification and Validation activities, Project Planning, and Design Change documentation practices. In addition to reviewing Design History Files, the candidate will also be responsible for conducting the remediation of all aspects of design control documentation to comply with company procedures. This work will include coordinating review and remediation activities within the GRQP team and along with external third party contractors.
Qualifications
A minimum of a Bachelor’s degree in Mechanical Engineering or another Engineering discipline is required. A minimum of 4+ years of product development or design control experience or equivalent is required. Experience with Class I and II medical devices is required. Experience in spine or orthopedic medical device industry is highly preferred. Experience in medical device design principles, material selection, ability to verify and validate design concepts, and understand design failure modes is required. Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T are required. Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc) is required. Experience with FDA Medical Device guidelines is required. The ability to effectively communicate with other team members is also required. This position may require up to 15% travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
Primary Location:North America-United States-Massachusetts-Raynham
Organization: DePuySynthes Products LLC (6149)
Job: R&D Engineering (R&D)
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.