Engineering Specialist

The Engineering Specialist I supports the design, development, and integration of medical device products, including new product introductions (NPI) and sustaining engineering for legacy systems. This entry level role is ideal for candidates with a background in mechanical, biomedical, or electrical engineering and an interest in medical device manufacture and associated analysis software. Familiarity with medical physics including medical device imaging and analysis (CT, MRI, X-Ray) is a plus. The position emphasizes hands-on technical work, documentation, and collaboration with cross-functional teams in a regulated environment. This role is fully on-site. Only applicants who do not require Visa sponsorship will be considered for this role. Key Areas of Responsibility: Assist in new product development and introduction (NPI) activities: o Support concept generation, design, prototyping, and testing. o Participate in risk assessment, verification, and validation tasks. o Help prepare design documentation in compliance with ISO and FDA standards. Collaborate with other engineers, Operations’ Management and Associates, and other key departments to ensure design feasibility and smooth production transition. Conduct basic experiments and feasibility studies under guidance. Provide technical support and troubleshooting To improve production quality and foster continuous improvement. Maintain accurate records and contribute to continuous improvement initiatives. Create and revise engineering data in our Enterprise Management Program to ensure accurate and efficient product manufacturing and quality control. Qualifications and Experience: Knowledge, Skills and Experience: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or Electrical Engineering. 0–2 years of engineering experience (internships or co-op experience preferred). Understanding of medical manufacturing processes or software integration is a plus. Familiarity with CAD tools (e.g., SolidWorks) andProduct Lifecycle Management (PLM) tools. Knowledge of of Enterprise Resource Programs (ERP systems) is a plus. . Experience in mechanical, electrical or software design is a plus. Strong attention to detail, organizational skills, and ability to learn quickly. Effective communication and teamwork skills. Ability to learn and adapt in a fast-paced environment to meet all deliverables including safety, cost, and milestone dates Problem-solving mindset and willingness to take initiative. Commitment to quality and regulatory compliance.