PH
Job Description
- Experienced Senior Engineering Manager to lead our R&D X-ray Image Chain (Detectors, Grids, Collimator, Tubes and Generators etc.) team and oversee our Norm Compliance Officers. This dual role requires a blend of technical acumen and people leadership to ensure the successful development and compliance of our diagnostic X-ray systems.
- Job Responsibility:
- Engineering Management
- Lead and mentor the R&D Image Chain Components (flat panel X-ray detectors, anti-scatter grids, generators, collimators and tubes)
- Oversee pre-development, product introductions, and lifecycle management of Image Chain Components.
- Manage Image Chain components road mapping in collaboration with external suppliers & releases with an international, cross-functional team.
- Coordinate technical investigations into customer complaints.
- Supervise Image chain advanced development activities.
- Ensure product quality through thorough tests and requirements engineering.
- Collaborate on software development projects.
- Norm Compliance Leadership
- Review product requirements related to safety, EMC, and environmental standards like IEC, EN, and ISO.
- Oversee compliance test plans, including standards such as IEC60601 series and ISO 10993.
- Oversee risk assessment and mitigation for product safety.
- Support usability and software teams in creating certification documentation.
- Ensure third-party component compliance and liaise with certification agencies (like TUV/CSA).
- Oversee technical file deliverables for MDD, MDR, RED, REACH, and RoHS regulations.
- Support audits and regulatory submissions (FDA, Notified Body, INMETRO).
- Maintain DXR compliance lab qualifications according to ISO17025.
- Train and guide cross-functional teams on regulatory standards and compliance execution.
- Stay updated on regulatory changes and timely closure of standards gap assessments.
- Job Knowledge, Skills and Experience:
- Educational Background : BE, BTech, ME, or MTech degree, preferably in Biomedical, Electrical, Electronics, or Instrumentation.
- Experience :
- Minimum 15 years in R&D and engineering roles, with 3 to 5 years in System Engineering (preferably in product safety and norm compliance)
- Minimum 3 years of people management experience
- Technical Skills:
- Medical device design and development experience in imaging modalities (like X-Ray, CT, MRI, Ultrasound)
- System Engineering - preferred experience with Image Chain/Acquisition, product safety and compliance
- Proficiency in regulatory submissions and relevant compliance standards (e.g., CE Marking, FDA, Health Canada).
- Preferred experience in product design and managing compliance documentation.
- Preferred familiarity with IEC62304, ISO14971, IEC60601 series and ISO 10993
- Leadership Skills:
- Proven leadership and mentoring abilities.
- Strong problem-solving and project management skills.
- Excellent communication and stakeholder management capabilities.
- Ability to train and develop team members on compliance and regulatory standards.