The Product/Process Development Engineer is a primary engineering resource for the continuous improvement of current device, and development of new platform and derivative products as necessary. This role will be responsible for ensuring that the requisite design controls are in place for all product development activities, from concept through design transfer. Additionally, the Engineer will be responsible for completion of all phases of the product development lifecycle as well as understanding and mitigating any product risks, evaluating safety and effectiveness, and implementing and executing proper test plans at the various stages of development. This role is primarily responsible for the underlying design history file for any product developed as well as for assisting in sustaining engineering and continuous improvement activities.
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Duties and Responsibilities
Designs and develops new products, product improvements and line extensions in accordance with corporate objectives.
Manages projects on schedule and within budget; ensuring design, deliverables and documentation are performed to company, industry, and regulatory requirements.
Leads DFM activities internally and with suppliers to create robust designs capable of high-volume manufacturing.
Develops and executes test protocols to ensure product safety and efficacy.
Works within a cross-functional team and provides oversight of third-party vendors and service providers such as design firms, component suppliers, and test laboratories.
Collaborates with Marketing, Medical Affairs, Scientific Affairs, and others to document user and product requirements.
Designs, documents, implements, and validates methods for production as necessary to support new products or product improvements.
Designs experiments (DOE) and analyzes data to present for submission to regulatory bodies. Works with CROs to execute GLP studies.
Support Quality and Regulatory activities including preventative and corrective actions, reviewing Engineering Change Notifications, engaging in internal and third-party audits, and participating in change control and quality system reviews as the engineering representative.
Works with Project Management to coordinate testing activities and ensuring on-time submission of design projects.
Identifies user requirements product requirements for specific improvements or revisions of current device and associated accessories and develops the corresponding URS and PRD documentation.
Technical Knowledge
Familiarity with 21 CFR 820 and ISO 13485 and 14971 – design controls and risk management in the medical device space.
Strong technical background in medical device design, verification and validation, systems engineering, product development workflows, product testing and transfer of validated methods to manufacturing.
Proficiency in 3D CAD modeling, preferably Solidworks and project scheduling.
Cell culturing and analysis or regenerative medicine devise expertise is a plus.
Scientific understanding of devices used in soft tissue injuries and/or dermatological diseases preferred
Founded in 1986 by a group of real-time automation & system solution engineers, Xyntek Incorporated, a CXV Global Company is a global leader in real-time IT and industrial automation solutions. Xyntek is headquartered in Philadelphia, PA with offices across the US. Xyntek’s mission is to form technological partnerships with world-class R&D and Manufacturing organizations to provide Validated Automation and Information Technology solutions, customized per your business and technology requirements. Our Engineering Business Units offer a full range of IT & engineering design, development, implementation, and quality & compliance solutions that deliver flexibility, scalability, operational efficiencies and integrity in controlled production environments.
