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.
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.