Design and Mechanical Engineer – Medical Devices

Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below. Join a global leader medical device company. Design and manufacture technology used in spine and orthopedic surgeries You will work on the design and development of surgical implants and instruments, collaborating with engineers, surgeons, and cross-functional teams to bring innovative products to market. Full‐time | W2 | M-F 8am- 5pm | On site Audubon PA (outside of Philadelphia) Qualifications 4+ years of mechanical and medical device design engineering experience. II and III medical device experience Experience with CREO or SolidWorks for mechanical design and documentation. Experience working within regulated environments (ISO 13485 / FDA). Ability to work in both engineering and clinical environments, including operating rooms and labs Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Bioengineering, or related field. Benefits: Visa sponsorship supported within US W2 contract Audubon, PA (outside Philadelphia) Bonus for relocation within US and annual bonuses Work directly with surgeons Full product development lifecycle exposure Key Responsibilities Product Development Lead the design and development of surgical instruments and implants using CAD software (CREO). Develop and maintain project plans and FDA-compliant Design History Files (DHF). Perform design verification and validation to ensure designs meet technical specifications. Manage assigned projects to ensure timely completion while maintaining compliance with regulatory requirements. Collaborate with internal prototype teams and external vendors for rapid prototyping and testing. Support preparation of regulatory submissions to the FDA. Customer Engagement Work directly with surgeons and clinical users to gather product feedback and translate clinical needs into design requirements. Participate in product launches, sales training, and customer visits. Support surgical cases in the operating room to observe device performance and identify opportunities for improvement. Cross-Functional Collaboration Partner with marketing and product management to develop market strategies and forecasts. Collaborate with operations and manufacturing to support production and commercialization. Conduct competitive and industry research to ensure innovative product development. Product Lifecycle & Sustaining Support the lifecycle management of commercialized products. Drive design improvements, cost reduction initiatives, and engineering changes. Work closely with Quality, Regulatory, Manufacturing, and Supply Chain teams to ensure product performance and compliance. The IN group is here to support you specifically with the recruitment and hiring process for job opportunities. xsgimln Our role is focused on guiding you through these steps. If you have any questions related to your application or next steps in the hiring process, Apply, and please feel free to reach out.