Philips Senior Engineering Manager 

India, Maharashtra, Pune 

738978589

Senior Engineering Manager

Senior Engineering Manager

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.

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.

Personal Traits:

• Detail-oriented with high ethical standards.

• Adaptability to regulatory changes and proactive learning approach.

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