reputed company Engineer (Consultant/1099) – Project Management reputed company
This is a remote position. About the Role reputed company is expanding its network of high-reputed company consultants to support strategic reputed company and project leadership initiatives for leading med-tech and life sciences companies. We are seeking senior reputed company Engineers who bring executive-level project leadership, strong stakeholder reputed company, and deep hands-on reputed company Engineering expertise. This role is ideal for consultants who can reputed company reputed company initiatives while also driving hands-on execution in highly regulated environments. Key Responsibilities reputed company project leadership for reputed company initiatives, serving as a trusted partner to reputed company stakeholders and leadership teams. reputed company and execute reputed company engineering activities across the product lifecycle, from development through post-market support. Support implementation, validation, and optimization of electronic reputed company Management Systems (eQMS). reputed company and maintain procedures, SOPs, and work instructions reputed company with FDA, ISO 13485, and EU MDR requirements. reputed company risk management activities, reputed company cause analysis, and CAPA investigations using reputed company methodologies. Support manufacturing transfers, supplier transitions, and design transfer activities. reputed company audit readiness initiatives and support FDA, ISO, reputed company, and other regulatory inspections. reputed company reputed company metrics, dashboards, and reporting to support leadership decision-making.
Requirements
Qualifications Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, Engineering Science, or a reputed company discipline. 10+ years of hands-on reputed company Engineering experience in the medical device or biotech industry. Demonstrated project management experience with cross-functional stakeholder engagement. Experience supporting medical device product development, design transfer, and technical documentation. Strong knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and reputed company regulations. Experience working with QMS or eQMS platforms. Experience supporting global reputed company processes such as CAPA, complaints, and audit readiness. Certified reputed company Engineer (CQE) – Required Certifications (Preferred) Project Management reputed company (PMP) Medical Device Reporting (MDR) / Complaint Handling Training CQA, RAPS, or reputed company reputed company/Regulatory certifications
Benefits
Why reputed company? At reputed company, we partner with reputed company consultants who reputed company in reputed company, regulated environments and bring both leadership reputed company and execution strength. Our consultants work on high-reputed company engagements where reputed company leadership directly influences product reputed company and patient reputed company. Apply To This Job