- Company Name
- Intellijoint Surgical Inc.
- Job Title
- Sustaining Engineer
- Job Description
-
**Job Title**: Sustaining Engineer
**Role Summary**
Ensure ongoing regulatory, quality, and safety compliance for commercialized medical device products. Drive supplier issue resolution, product and process improvement, and technical design changes while coordinating cross‑functional teams across R&D, Quality, Operations, and Supply Chain.
**Expectations**
- Strong engineering foundation in mechanical and software design for medical devices.
- Analytical and methodical approach to data interpretation and root‑cause analysis.
- Excellent collaboration and communication skills for stakeholder engagement without direct authority.
**Key Responsibilities**
1. Supplier Management
- Resolve technical issues, manage obsolescence, and support supplier quality improvements.
2. Data & Trend Analysis
- Analyze product complaints, field feedback, and post‑market surveillance to identify systemic issues.
3. Corrective & Preventive Actions (CAPA)
- Partner with QA to address CAPAs, NCRs, and audit findings with timely resolutions.
4. Equipment Qualification
- Own calibration and IQ/OQ/PQ for operations assets.
5. Design Change & Documentation
- Evaluate, approve, and lead design change activities; perform risk assessments; facilitate design transfer; draft work instructions and production risk reports.
6. Process Improvement
- Contribute to sustaining process and documentation enhancements.
7. Project Management
- Prioritize and coordinate resources; manage timelines, budgets, and stakeholder alignment.
8. New Market Expansion
- Assess regional regulatory, operational, and engineering requirements for market entry and implement compliant processes.
**Required Skills**
- Mechanical/Biomedical engineering expertise with medical device manufacturing experience.
- Proficiency in reading and interpreting engineering drawings, specifications, and change documentation.
- Knowledge of medical device regulations (ISO 13485, FDA, MDR) and quality systems.
- Supplier relationship and obsolescence management experience.
- Data‑driven decision making, root‑cause analysis, and CAPA implementation.
- Equipment qualification (IQ/OQ/PQ) and calibration skills.
- Project management, cross‑functional coordination, and influence without authority.
- Strong written and verbal communication.
**Required Education & Certifications**
- Bachelor’s degree in Mechanical, Biomedical, or related engineering field.
- 3–7 years of experience in medical device, life sciences, or regulated manufacturing environment supporting commercialized products.
- Familiarity with ISO 13485, FDA, and MDR regulatory requirements.
- (Optional) Certifications such as Six Sigma Green/Black Belt, QA, or Regulatory Affairs preferred.