Centers for Disease Control and Prevention (CDC), Continuous Improvement, Contract Manufacturing, Customer Relations, Customer Satisfaction, Document Management, Documentation Design, Engineering, Entrepreneurship, FDA (Food and Drug Administration), FDA Requirements, ISO (International Organization for Standardization), Maintain Compliance, Manufacturing, Manufacturing Operations, Medical Equipment, Medical Protocols, Process Improvement, Product Design, Product Development, Product Support, Project Design, Quality Metrics, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Requirements Management, Risk Management, Team Player, Technical/Engineering Design, Validation Testing
About Medicom
Do you think you have what it takes to work in an organization where creativity, ambition and initiative are valued, and where integrity drives everything we do?
Medicom has been in business for over 35 years and has retained its entrepreneurial spirit. By working with us, you will have the opportunity to get involved, make a real impact and contribute to the continued growth of the company. We live our values every day by focusing on customer satisfaction while promoting teamwork, accountability and empathy.
Our team thrives in fast-paced environments. You will benefit from flexibility to balance your work, personal life and well-being.
The Opportunity
Medicom is looking for a Technical Specialist to join our team. This role is 100% on-site and focused on supporting product design and development activities for our medical device portfolio. You will play a key role in the successful execution of design control, technical development, and process improvement initiatives to bring new and enhanced products to market while ensuring compliance with global regulatory and quality standards.
What You Will Do
- Execute product design and development tasks supporting Medicom's United Medical Enterprise (UME) contract manufacturing operations and NAM Product Development objectives
- Support new product development and sustaining engineering projects from concept to commercialization
- Participate in design control activities: specification definition, verification & validation, design reviews, labeling development, and risk management
- Support design transfer and continuous improvement initiatives across manufacturing sites
- Ensure compliance with medical device standards and regulations including CMDR, FDA QSR, ISO 13485, CDC NIOSH, and EU MDR
- Support regulatory audits (FDA, notified bodies) and remediation projects related to design control documentation