Sr. Project Engineer

IntePros is currently looking for a Sr. Project Engineer to join one of our growing Medical Device clients in Audubon, PA. The Sr. 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. This individual will work closely with spine surgeons and all other functions of the company to ensure high quality and on-time product introductions.Sr. Project Engineer ResponsibilitiesObtain market feedback from spine surgeons and other customers to determine functional and design specifications for new product developmentCreate and maintain project plans and FDA complaint Design history Files (DHF) for each projectManage of all aspects of project to ensure timely completion of tasks while remaining in full compliance with client quality system and other applicable regulatory bodiesDesign and develop instruments and implants using Pro/E softwarePartner with in-house prototype shop and outside vendors for rapid prototyping and evaluationPerform design verification and validation activities to ensure designs meet specifications Partner with marketing and product managers to develop forecasts and market plansAssist in the writing of regulatory applications to the FDA and other regulatory bodies.Collaborate with the operations department to setup manufacturing and/or purchasing as appropriate for each projectParticipate in product introductions through sales training, customer calls/visits, etc.Maintain diligent post introduction monitoring to address and customer requests for changesResearch market and competition on an ongoing basis to ensure that client has cutting edge technology in all markets enteredAdhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policiesEnsure 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 roleRepresent 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 parties of clientReasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.Sr. Project Engineer QualificationsMinimum five years of mechanical design engineering experience, preferably in the medical device fieldBachelor's degree in Mechanical Engineering or similar area of studyProficiency in Pro/E software for design and drafting requiredProven leader of people with strong self-starting skillsAbility to work in fast paced environment; Multi-tasking abilities required for successful job completionWell organized, detail oriented and team player capable of working in a deadline dictated environmentAbility to adequately represent and reflect company philosophy to customers, investors, regulatory agencies, and industry peersProficient in preparation of reports and budgetsProficient in Microsoft OfficePhysical DemandsThe physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.Required to sit; climb or balance; and stoop, kneel, crouch or crawlRequired to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 poundsRequired to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus