What are the responsibilities and job description for the Mechanical / Product Design Engineer position at I3 INFOTEK INC?
Job Description
The Mechanical/Product Design Engineer will support product development, testing, and ongoing sustaining activities for the Infusion Pump platform. The role requires strong mechanical design expertise, risk management knowledge, and the ability to collaborate across engineering and manufacturing teams.
Responsibilities
Product Design & Mechanical Engineering
- Perform mechanical design changes including part and product modifications and BOM updates.
- Support sustaining engineering activities, including addressing component obsolescence and product lifecycle needs.
- Collaborate in design transfer activities and provide ongoing manufacturing support.
Verification & Validation (V&V)
- Develop and execute test protocols and test method validations.
- Support V&V activities to ensure design robustness and compliance.
Risk Management (ISO 14971)
- Perform Risk File Updates at both System and Sub-System levels.
- Participate in Risk Reviews (PRR, EBRR) ensuring compliance with medical device risk standards.
Cross-functional Collaboration
- Work with cross-functional teams during TRB, CCB, and CIT meetings.
- Participate in technical and final design reviews.
- Coordinate with external vendors to support development and sustaining needs.
- Assist with onboarding new internal team members.
General Support
- Provide additional engineering support as required to maintain business continuity for the product line.