Project Engineer

IntePros is currently looking for a Project Engineer to join one of our growing Medical Device clients in Audubon, PA. The Project Engineer will be responsible for all engineering functions of their product lines. This includes bringing a product from idea/concept through design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. The Project Engineer will work with surgeons and all other functions of the company to ensure high quality and on-time product introductions.Project Engineer Responsibilities:Obtains market feedback from surgeons and other customers to determine functional and design specifications for new product developmentCreates and maintains project plans and FDA complaint Design history Files (DHF) for each projectManages all aspects of assigned projects to ensure timely completion of tasks while remaining in full compliance with client quality system and other applicable regulatory bodiesDesigns and develops instruments and implants using Pro/E and SolidWorks softwarePartners with in-house prototype shop and outside vendors for rapid prototyping and evaluationPerforms design verification and validation activities to ensure designs meet specificationsCollaborates with marketing and product managers to develop forecasts and market plansAssists in the writing of regulatory applications to the FDA and other regulatory bodiesPartners with the operations department to setup manufacturing and/or purchasing as appropriate for each projectParticipates in product introductions through sales training, customer calls/visits, etc.Maintains diligent post introduction monitoring to address and customer requests for changesResearches industry and direct competitors on an ongoing basis to ensure that client has cutting edge technology in all markets enteredAdheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your roleRepresents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third partiesReasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.Project Engineer Qualifications:3-7 years experience in mechanical design engineering; Medical device experience strongly preferredBachelor's Degree in Mechanical Engineering, Bioengineering, Biomedical Engineering or a similar degreeProficiency in Pro/E and/or SolidWorks software for design and draftingWell organized, detail oriented, and team player capable of working in a deadline driven environmentExperience in preparing reports and managing project budgetsStrong knowledge of Microsoft OfficeAbility to attend surgeries and/or labs#LI-DR2